Upper GI Tract

The prevalence of eosinophilic esophagitis (EoE) has increased fivefold in the United States since 2009, now affecting about 1 in 700 people and totaling $1.32 billion in annual healthcare costs, according to recent research.

Although EoE has been considered a rare disease, the chronic condition is becoming more common, and healthcare providers should expect to encounter EoE in clinical settings, the study authors wrote.

“Our last assessment of the prevalence and burden of EoE was more than 10 years ago, and we had a strong suspicion we would continue to see increased numbers of patients with EoE and an increasing cost burden related to the condition in the United States,” said senior author Evan S. Dellon, MD, MPH, AGAF, professor of gastroenterology and hepatology and director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, Chapel Hill, North Carolina.

“EoE is becoming more common,” Dellon said. “Healthcare providers should expect to see EoE in their practices, including in the primary care setting, emergency departments, allergy practices, GI [gastrointestinal] practices, ENT clinics, and endoscopy suites.”

The study was published in Clinical Gastroenterology and Hepatology.

Estimating EoE Prevalence

Dellon and colleagues analyzed the Merative MarketScan Commercial Claims and Encounters and Medicare Fee-for-Service databases to calculate the annual prevalence of EoE, as well as age- and sex-stratified estimates standardized to the US population. They also calculated healthcare utilization, including medications and endoscopic procedures, to estimate annual EoE-associated costs. Since the EoE billing code was introduced in 2008, the analysis included 2009-2022 MarketScan and 2009-2017 Medicare data.

In the MarketScan database, the research team identified 20,435 EoE cases in 2022, with a mean age of 38 years, 16% younger than 18 years, 62% men, and 41% with a comorbid allergic disease code. The most common symptoms and diagnoses were dysphagia (39%), abdominal pain or dyspepsia (24%), and esophageal stricture (19%). Over time, patients also had previous codes for comorbid allergic diseases (64%), dysphagia (62%), or esophageal stricture (32%).

In the Medicare database, the research team identified 1913 EoE cases in 2017, with a mean age of 73 years, 47% men, 90% non-Hispanic White, and 36% with a comorbid allergic disease. The most common symptoms and diagnoses were dysphagia (49%), abdominal pain or dyspepsia (35%), and esophageal stricture (30%). Over time, patients also had codes for comorbid allergic diseases (64%), dysphagia (65%), or esophageal stricture (42%).

The database numbers translated to EoE prevalences of about 163 cases per 100,000 people in MarketScan in 2022 and 64 cases per 100,000 people in Medicare in 2017. Since 2009, there has been a fivefold increase in prevalence in both databases.

In MarketScan, the prevalence was higher among men than among women, at 204 vs 122 cases per 100,000 people. For both sexes, peak prevalence occurred between ages 40 and 44.

In Medicare, prevalence was also higher among men than among women, at 79 vs 55 cases per 100,000 people. Peak prevalence occurred between ages 65 and 69.

Standardized to the US population, EoE prevalence was 142.5 cases per 100,000 people, extrapolating to 472,380 cases. The overall prevalence was approximately 1 in 700, with rates of 1 in 617 for those younger than 65 years and 1 in 1562 for those aged ≥ 65 years.

“The rapidly increasing prevalence year over year for the entire timeframe of the study was surprising, as were our estimates of the total number of EoE patients in the US, which suggests that EoE is no longer a rare disease and is now seen in about 1 in 700 people,” Dellon said. “This almost triples our prior estimates of 1 in 2000 from 10 years ago, with all trends suggesting that the prevalence will continue to increase.”

 

Calculating EoE Costs

In terms of procedures, endoscopy with dilation or biopsy was used in about 60%-70% of patients with EoE in both MarketScan and Medicare during the years analyzed. In addition, upper endoscopy with biopsy was coded in 80%-90% of patients, guidewire-based dilation in 11%-17% of patients, and balloon-based dilation in 13%-20% of patients.

In terms of prescription medications, proton pump inhibitors (41%) and topical steroids (26%) were the most common in MarketScan in 2022, as well as in Medicare in 2017, at 32% and 9%, respectively.

When looking at costs by age and sex, the male cohort with the highest costs was aged 10-14 years, estimated at $106.7 million. Among the female cohort, the highest costs were associated with ages 15-19, estimated at $46.5 million.

Overall, total EoE-associated healthcare costs were estimated to be $1.04 billion in 2017, and when adjusted for inflation, the costs were estimated at $1.32 billion in 2024. This is likely an underestimate, the authors wrote, given that EoE prevalence has likely increased for ages 65 or older since 2017 and for all ages since 2022.

“Researching the prevalence and costs is essential to improving patient care by highlighting the growing burden of this recently recognized and growing chronic disease, guiding policy and insurer decisions, and advocating for better access to effective treatments and support for patients,” said Joy Chang, MD, assistant professor of medicine in the Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan.Chang, who wasn’t involved with this study, specializes in eosinophilic GI diseases and researches patient-physician preferences and decision-making in EoE care.

“Clinicians should remain vigilant for symptoms, utilize guideline-based diagnostic approaches, and consider both medical and dietary treatment strategies to optimize patient outcomes and reduce long-term costs,” she said. “Increased awareness and timely intervention can help mitigate the growing impact of this chronic condition.”

The study was supported by a National Institutes of Health grant and used resources from the University of North Carolina Center for Gastrointestinal Biology and Disease. Dellon reported receiving research funding from and having consultant roles with numerous pharmaceutical companies and organizations. Chang reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

The prevalence of eosinophilic esophagitis (EoE) has increased fivefold in the United States since 2009, now affecting about 1 in 700 people and totaling $1.32 billion in annual healthcare costs, according to recent research.

Although EoE has been considered a rare disease, the chronic condition is becoming more common, and healthcare providers should expect to encounter EoE in clinical settings, the study authors wrote.

“Our last assessment of the prevalence and burden of EoE was more than 10 years ago, and we had a strong suspicion we would continue to see increased numbers of patients with EoE and an increasing cost burden related to the condition in the United States,” said senior author Evan S. Dellon, MD, MPH, AGAF, professor of gastroenterology and hepatology and director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, Chapel Hill, North Carolina.

“EoE is becoming more common,” Dellon said. “Healthcare providers should expect to see EoE in their practices, including in the primary care setting, emergency departments, allergy practices, GI [gastrointestinal] practices, ENT clinics, and endoscopy suites.”

The study was published in Clinical Gastroenterology and Hepatology.

Estimating EoE Prevalence

Dellon and colleagues analyzed the Merative MarketScan Commercial Claims and Encounters and Medicare Fee-for-Service databases to calculate the annual prevalence of EoE, as well as age- and sex-stratified estimates standardized to the US population. They also calculated healthcare utilization, including medications and endoscopic procedures, to estimate annual EoE-associated costs. Since the EoE billing code was introduced in 2008, the analysis included 2009-2022 MarketScan and 2009-2017 Medicare data.

In the MarketScan database, the research team identified 20,435 EoE cases in 2022, with a mean age of 38 years, 16% younger than 18 years, 62% men, and 41% with a comorbid allergic disease code. The most common symptoms and diagnoses were dysphagia (39%), abdominal pain or dyspepsia (24%), and esophageal stricture (19%). Over time, patients also had previous codes for comorbid allergic diseases (64%), dysphagia (62%), or esophageal stricture (32%).

In the Medicare database, the research team identified 1913 EoE cases in 2017, with a mean age of 73 years, 47% men, 90% non-Hispanic White, and 36% with a comorbid allergic disease. The most common symptoms and diagnoses were dysphagia (49%), abdominal pain or dyspepsia (35%), and esophageal stricture (30%). Over time, patients also had codes for comorbid allergic diseases (64%), dysphagia (65%), or esophageal stricture (42%).

The database numbers translated to EoE prevalences of about 163 cases per 100,000 people in MarketScan in 2022 and 64 cases per 100,000 people in Medicare in 2017. Since 2009, there has been a fivefold increase in prevalence in both databases.

In MarketScan, the prevalence was higher among men than among women, at 204 vs 122 cases per 100,000 people. For both sexes, peak prevalence occurred between ages 40 and 44.

In Medicare, prevalence was also higher among men than among women, at 79 vs 55 cases per 100,000 people. Peak prevalence occurred between ages 65 and 69.

Standardized to the US population, EoE prevalence was 142.5 cases per 100,000 people, extrapolating to 472,380 cases. The overall prevalence was approximately 1 in 700, with rates of 1 in 617 for those younger than 65 years and 1 in 1562 for those aged ≥ 65 years.

“The rapidly increasing prevalence year over year for the entire timeframe of the study was surprising, as were our estimates of the total number of EoE patients in the US, which suggests that EoE is no longer a rare disease and is now seen in about 1 in 700 people,” Dellon said. “This almost triples our prior estimates of 1 in 2000 from 10 years ago, with all trends suggesting that the prevalence will continue to increase.”

 

Calculating EoE Costs

In terms of procedures, endoscopy with dilation or biopsy was used in about 60%-70% of patients with EoE in both MarketScan and Medicare during the years analyzed. In addition, upper endoscopy with biopsy was coded in 80%-90% of patients, guidewire-based dilation in 11%-17% of patients, and balloon-based dilation in 13%-20% of patients.

In terms of prescription medications, proton pump inhibitors (41%) and topical steroids (26%) were the most common in MarketScan in 2022, as well as in Medicare in 2017, at 32% and 9%, respectively.

When looking at costs by age and sex, the male cohort with the highest costs was aged 10-14 years, estimated at $106.7 million. Among the female cohort, the highest costs were associated with ages 15-19, estimated at $46.5 million.

Overall, total EoE-associated healthcare costs were estimated to be $1.04 billion in 2017, and when adjusted for inflation, the costs were estimated at $1.32 billion in 2024. This is likely an underestimate, the authors wrote, given that EoE prevalence has likely increased for ages 65 or older since 2017 and for all ages since 2022.

“Researching the prevalence and costs is essential to improving patient care by highlighting the growing burden of this recently recognized and growing chronic disease, guiding policy and insurer decisions, and advocating for better access to effective treatments and support for patients,” said Joy Chang, MD, assistant professor of medicine in the Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan.Chang, who wasn’t involved with this study, specializes in eosinophilic GI diseases and researches patient-physician preferences and decision-making in EoE care.

“Clinicians should remain vigilant for symptoms, utilize guideline-based diagnostic approaches, and consider both medical and dietary treatment strategies to optimize patient outcomes and reduce long-term costs,” she said. “Increased awareness and timely intervention can help mitigate the growing impact of this chronic condition.”

The study was supported by a National Institutes of Health grant and used resources from the University of North Carolina Center for Gastrointestinal Biology and Disease. Dellon reported receiving research funding from and having consultant roles with numerous pharmaceutical companies and organizations. Chang reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

The prevalence of eosinophilic esophagitis (EoE) has increased fivefold in the United States since 2009, now affecting about 1 in 700 people and totaling $1.32 billion in annual healthcare costs, according to recent research.

Although EoE has been considered a rare disease, the chronic condition is becoming more common, and healthcare providers should expect to encounter EoE in clinical settings, the study authors wrote.

“Our last assessment of the prevalence and burden of EoE was more than 10 years ago, and we had a strong suspicion we would continue to see increased numbers of patients with EoE and an increasing cost burden related to the condition in the United States,” said senior author Evan S. Dellon, MD, MPH, AGAF, professor of gastroenterology and hepatology and director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, Chapel Hill, North Carolina.

“EoE is becoming more common,” Dellon said. “Healthcare providers should expect to see EoE in their practices, including in the primary care setting, emergency departments, allergy practices, GI [gastrointestinal] practices, ENT clinics, and endoscopy suites.”

The study was published in Clinical Gastroenterology and Hepatology.

Estimating EoE Prevalence

Dellon and colleagues analyzed the Merative MarketScan Commercial Claims and Encounters and Medicare Fee-for-Service databases to calculate the annual prevalence of EoE, as well as age- and sex-stratified estimates standardized to the US population. They also calculated healthcare utilization, including medications and endoscopic procedures, to estimate annual EoE-associated costs. Since the EoE billing code was introduced in 2008, the analysis included 2009-2022 MarketScan and 2009-2017 Medicare data.

In the MarketScan database, the research team identified 20,435 EoE cases in 2022, with a mean age of 38 years, 16% younger than 18 years, 62% men, and 41% with a comorbid allergic disease code. The most common symptoms and diagnoses were dysphagia (39%), abdominal pain or dyspepsia (24%), and esophageal stricture (19%). Over time, patients also had previous codes for comorbid allergic diseases (64%), dysphagia (62%), or esophageal stricture (32%).

In the Medicare database, the research team identified 1913 EoE cases in 2017, with a mean age of 73 years, 47% men, 90% non-Hispanic White, and 36% with a comorbid allergic disease. The most common symptoms and diagnoses were dysphagia (49%), abdominal pain or dyspepsia (35%), and esophageal stricture (30%). Over time, patients also had codes for comorbid allergic diseases (64%), dysphagia (65%), or esophageal stricture (42%).

The database numbers translated to EoE prevalences of about 163 cases per 100,000 people in MarketScan in 2022 and 64 cases per 100,000 people in Medicare in 2017. Since 2009, there has been a fivefold increase in prevalence in both databases.

In MarketScan, the prevalence was higher among men than among women, at 204 vs 122 cases per 100,000 people. For both sexes, peak prevalence occurred between ages 40 and 44.

In Medicare, prevalence was also higher among men than among women, at 79 vs 55 cases per 100,000 people. Peak prevalence occurred between ages 65 and 69.

Standardized to the US population, EoE prevalence was 142.5 cases per 100,000 people, extrapolating to 472,380 cases. The overall prevalence was approximately 1 in 700, with rates of 1 in 617 for those younger than 65 years and 1 in 1562 for those aged ≥ 65 years.

“The rapidly increasing prevalence year over year for the entire timeframe of the study was surprising, as were our estimates of the total number of EoE patients in the US, which suggests that EoE is no longer a rare disease and is now seen in about 1 in 700 people,” Dellon said. “This almost triples our prior estimates of 1 in 2000 from 10 years ago, with all trends suggesting that the prevalence will continue to increase.”

 

Calculating EoE Costs

In terms of procedures, endoscopy with dilation or biopsy was used in about 60%-70% of patients with EoE in both MarketScan and Medicare during the years analyzed. In addition, upper endoscopy with biopsy was coded in 80%-90% of patients, guidewire-based dilation in 11%-17% of patients, and balloon-based dilation in 13%-20% of patients.

In terms of prescription medications, proton pump inhibitors (41%) and topical steroids (26%) were the most common in MarketScan in 2022, as well as in Medicare in 2017, at 32% and 9%, respectively.

When looking at costs by age and sex, the male cohort with the highest costs was aged 10-14 years, estimated at $106.7 million. Among the female cohort, the highest costs were associated with ages 15-19, estimated at $46.5 million.

Overall, total EoE-associated healthcare costs were estimated to be $1.04 billion in 2017, and when adjusted for inflation, the costs were estimated at $1.32 billion in 2024. This is likely an underestimate, the authors wrote, given that EoE prevalence has likely increased for ages 65 or older since 2017 and for all ages since 2022.

“Researching the prevalence and costs is essential to improving patient care by highlighting the growing burden of this recently recognized and growing chronic disease, guiding policy and insurer decisions, and advocating for better access to effective treatments and support for patients,” said Joy Chang, MD, assistant professor of medicine in the Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan.Chang, who wasn’t involved with this study, specializes in eosinophilic GI diseases and researches patient-physician preferences and decision-making in EoE care.

“Clinicians should remain vigilant for symptoms, utilize guideline-based diagnostic approaches, and consider both medical and dietary treatment strategies to optimize patient outcomes and reduce long-term costs,” she said. “Increased awareness and timely intervention can help mitigate the growing impact of this chronic condition.”

The study was supported by a National Institutes of Health grant and used resources from the University of North Carolina Center for Gastrointestinal Biology and Disease. Dellon reported receiving research funding from and having consultant roles with numerous pharmaceutical companies and organizations. Chang reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — A novel generative artificial intelligence (AI) framework known as trajectory flow matching (TFM) can predict the need for red blood cell transfusion and mortality risk in intensive care unit (ICU) patients with acute gastrointestinal (GI) bleeding, researchers reported at Digestive Disease Week^® (DDW) 2025.

Acute GI bleeding is the most common cause of digestive disease–related hospitalization, with an estimated 500,000 hospital admissions annually. It’s known that predicting the need for red blood cell transfusion in the first 24 hours may improve resuscitation and decrease both morbidity and mortality.

However, an existing clinical score known as the Rockall Score does not perform well for predicting mortality, Xi (Nicole) Zhang, an MD-PhD student at McGill University, Montreal, Quebec, Canada, told attendees at DDW. With an area under the curve of 0.65-0.75, better prediction is needed, said Zhang, whose coresearchers included Dennis Shung, MD, MHS, PhD, director of Applied Artificial Intelligence at Yale University School of Medicine, New Haven, Connecticut.

“We’d like to predict multiple outcomes in addition to mortality,” said Zhang, who is also a student at the Mila-Quebec Artificial Intelligence Institute.

As a result, the researchers turned to the TFM approach, applying it to ICU patients with acute GI bleeding to predict both the need for transfusion and in-hospital mortality risk. The all-cause mortality rate is up to 11%, according to a 2020 study by James Y. W. Lau, MD, and colleagues. The rebleeding rate of nonvariceal upper GI bleeds is up to 10.4%. Zhang said the rebleeding rate for variceal upper gastrointestinal bleeding is up to 65%.

The AI method the researchers used outperformed a standard deep learning model at predicting the need for transfusion and estimating mortality risk.

 

Defining the AI Framework

“Probabilistic flow matching is a class of generative artificial intelligence that learns how a simple distribution becomes a more complex distribution with ordinary differential equations,” Zhang told GI & Hepatology News. “For example, if you had a few lines and shapes you could learn how it could become a detailed portrait of a face. In our case, we start with a few blood pressure and heart rate measurements and learn the pattern of blood pressures and heart rates over time, particularly if they reflect clinical deterioration with hemodynamic instability.”

Another way to think about the underlying algorithm, Zhang said, is to think about a river with boats where the river flow determines where the boats end up. “We are trying to direct the boat to the correct dock by adjusting the flow of water in the canal. In this case we are mapping the distribution with the first few data points to the distribution with the entire patient trajectory.”

The information gained, she said, could be helpful in timing endoscopic evaluation or allocating red blood cell products for emergent transfusion.

 

Study Details

The researchers evaluated a cohort of 2602 patients admitted to the ICU, identified from the publicly available MIMIC-III database. They divided the patients into a training set of 2342 patients and an internal validation set of 260 patients. Input variables were severe liver disease comorbidity, administration of vasopressor medications, mean arterial blood pressure, and heart rate over the first 24 hours.

Excluded was hemoglobin, since the point was to test the trajectory of hemodynamic parameters independent of hemoglobin thresholds used to guide red blood cell transfusion.

The outcome measures were administration of packed red blood cell transfusion within 24 hours and all-cause hospital mortality.

The TFM was more accurate than a standard deep learning model in predicting red blood cell transfusion, with an accuracy of 93.6% vs 43.2%; P ≤ .001. It was also more accurate at predicting all-cause in-hospital mortality, with an accuracy of 89.5% vs 42.5%, P = .01.

The researchers concluded that the TFM approach was able to predict the hemodynamic trajectories of patients with acute GI bleeding defined as deviation and outperformed the baseline from the measured mean arterial pressure and heart rate.

 

Expert Perspective

“This is an exciting proof-of-concept study that shows generative AI methods may be applied to complex datasets in order to improve on our current predictive models and improve patient care,” said Jeremy Glissen Brown, MD, MSc, an assistant professor of medicine and a practicing gastroenterologist at Duke University who has published research on the use of AI in clinical practice. He reviewed the study for GI & Hepatology News but was not involved in the research.

“Future work will likely look into the implementation of a version of this model on real-time data.” he said. “We are at an exciting inflection point in predictive models within GI and clinical medicine. Predictive models based on deep learning and generative AI hold the promise of improving how we predict and treat disease states, but the excitement being generated with studies such as this needs to be balanced with the trade-offs inherent to the current paradigm of deep learning and generative models compared to more traditional regression-based models. These include many of the same ‘black box’ explainability questions that have risen in the age of convolutional neural networks as well as some method-specific questions due to the continuous and implicit nature of TFM.”

Elaborating on that, Glissen Brown said: “TFM, like many deep learning techniques, raises concerns about explainability that we’ve long seen with convolutional neural networks — the ‘black box’ problem, where it’s difficult to interpret exactly how and why the model arrives at a particular decision. But TFM also introduces unique challenges due to its continuous and implicit formulation. Since it often learns flows without explicitly defining intermediate representations or steps, it can be harder to trace the logic or pathways it uses to connect inputs to outputs. This makes standard interpretability tools less effective and calls for new techniques tailored to these continuous architectures.”

“This approach could have a real clinical impact,” said Robert Hirten, MD, associate professor of medicine and artificial intelligence, Icahn School of Medicine at Mount Sinai, New York City, who also reviewed the study. “Accurately predicting transfusion needs and mortality risk in real time could support earlier, more targeted interventions for high-risk patients. While these findings still need to be validated in prospective studies, it could enhance ICU decision-making and resource allocation.”

“For the practicing gastroenterologist, we envision this system could help them figure out when to perform endoscopy in a patient admitted with acute gastrointestinal bleeding in the ICU at very high risk of exsanguination,” Zhang told GI & Hepatology News.

The approach, the researchers said, will be useful in identifying unique patient characteristics, make possible the identification of high-risk patients and lead to more personalized medicine.

Hirten, Zhang, and Shung had no disclosures. Glissen Brown reported consulting relationships with Medtronic, OdinVision, Doximity, and Olympus. The National Institutes of Health funded this study.

A version of this article appeared on Medscape.com.

SAN DIEGO — A novel generative artificial intelligence (AI) framework known as trajectory flow matching (TFM) can predict the need for red blood cell transfusion and mortality risk in intensive care unit (ICU) patients with acute gastrointestinal (GI) bleeding, researchers reported at Digestive Disease Week^® (DDW) 2025.

Acute GI bleeding is the most common cause of digestive disease–related hospitalization, with an estimated 500,000 hospital admissions annually. It’s known that predicting the need for red blood cell transfusion in the first 24 hours may improve resuscitation and decrease both morbidity and mortality.

However, an existing clinical score known as the Rockall Score does not perform well for predicting mortality, Xi (Nicole) Zhang, an MD-PhD student at McGill University, Montreal, Quebec, Canada, told attendees at DDW. With an area under the curve of 0.65-0.75, better prediction is needed, said Zhang, whose coresearchers included Dennis Shung, MD, MHS, PhD, director of Applied Artificial Intelligence at Yale University School of Medicine, New Haven, Connecticut.

“We’d like to predict multiple outcomes in addition to mortality,” said Zhang, who is also a student at the Mila-Quebec Artificial Intelligence Institute.

As a result, the researchers turned to the TFM approach, applying it to ICU patients with acute GI bleeding to predict both the need for transfusion and in-hospital mortality risk. The all-cause mortality rate is up to 11%, according to a 2020 study by James Y. W. Lau, MD, and colleagues. The rebleeding rate of nonvariceal upper GI bleeds is up to 10.4%. Zhang said the rebleeding rate for variceal upper gastrointestinal bleeding is up to 65%.

The AI method the researchers used outperformed a standard deep learning model at predicting the need for transfusion and estimating mortality risk.

 

Defining the AI Framework

“Probabilistic flow matching is a class of generative artificial intelligence that learns how a simple distribution becomes a more complex distribution with ordinary differential equations,” Zhang told GI & Hepatology News. “For example, if you had a few lines and shapes you could learn how it could become a detailed portrait of a face. In our case, we start with a few blood pressure and heart rate measurements and learn the pattern of blood pressures and heart rates over time, particularly if they reflect clinical deterioration with hemodynamic instability.”

Another way to think about the underlying algorithm, Zhang said, is to think about a river with boats where the river flow determines where the boats end up. “We are trying to direct the boat to the correct dock by adjusting the flow of water in the canal. In this case we are mapping the distribution with the first few data points to the distribution with the entire patient trajectory.”

The information gained, she said, could be helpful in timing endoscopic evaluation or allocating red blood cell products for emergent transfusion.

 

Study Details

The researchers evaluated a cohort of 2602 patients admitted to the ICU, identified from the publicly available MIMIC-III database. They divided the patients into a training set of 2342 patients and an internal validation set of 260 patients. Input variables were severe liver disease comorbidity, administration of vasopressor medications, mean arterial blood pressure, and heart rate over the first 24 hours.

Excluded was hemoglobin, since the point was to test the trajectory of hemodynamic parameters independent of hemoglobin thresholds used to guide red blood cell transfusion.

The outcome measures were administration of packed red blood cell transfusion within 24 hours and all-cause hospital mortality.

The TFM was more accurate than a standard deep learning model in predicting red blood cell transfusion, with an accuracy of 93.6% vs 43.2%; P ≤ .001. It was also more accurate at predicting all-cause in-hospital mortality, with an accuracy of 89.5% vs 42.5%, P = .01.

The researchers concluded that the TFM approach was able to predict the hemodynamic trajectories of patients with acute GI bleeding defined as deviation and outperformed the baseline from the measured mean arterial pressure and heart rate.

 

Expert Perspective

“This is an exciting proof-of-concept study that shows generative AI methods may be applied to complex datasets in order to improve on our current predictive models and improve patient care,” said Jeremy Glissen Brown, MD, MSc, an assistant professor of medicine and a practicing gastroenterologist at Duke University who has published research on the use of AI in clinical practice. He reviewed the study for GI & Hepatology News but was not involved in the research.

“Future work will likely look into the implementation of a version of this model on real-time data.” he said. “We are at an exciting inflection point in predictive models within GI and clinical medicine. Predictive models based on deep learning and generative AI hold the promise of improving how we predict and treat disease states, but the excitement being generated with studies such as this needs to be balanced with the trade-offs inherent to the current paradigm of deep learning and generative models compared to more traditional regression-based models. These include many of the same ‘black box’ explainability questions that have risen in the age of convolutional neural networks as well as some method-specific questions due to the continuous and implicit nature of TFM.”

Elaborating on that, Glissen Brown said: “TFM, like many deep learning techniques, raises concerns about explainability that we’ve long seen with convolutional neural networks — the ‘black box’ problem, where it’s difficult to interpret exactly how and why the model arrives at a particular decision. But TFM also introduces unique challenges due to its continuous and implicit formulation. Since it often learns flows without explicitly defining intermediate representations or steps, it can be harder to trace the logic or pathways it uses to connect inputs to outputs. This makes standard interpretability tools less effective and calls for new techniques tailored to these continuous architectures.”

“This approach could have a real clinical impact,” said Robert Hirten, MD, associate professor of medicine and artificial intelligence, Icahn School of Medicine at Mount Sinai, New York City, who also reviewed the study. “Accurately predicting transfusion needs and mortality risk in real time could support earlier, more targeted interventions for high-risk patients. While these findings still need to be validated in prospective studies, it could enhance ICU decision-making and resource allocation.”

“For the practicing gastroenterologist, we envision this system could help them figure out when to perform endoscopy in a patient admitted with acute gastrointestinal bleeding in the ICU at very high risk of exsanguination,” Zhang told GI & Hepatology News.

The approach, the researchers said, will be useful in identifying unique patient characteristics, make possible the identification of high-risk patients and lead to more personalized medicine.

Hirten, Zhang, and Shung had no disclosures. Glissen Brown reported consulting relationships with Medtronic, OdinVision, Doximity, and Olympus. The National Institutes of Health funded this study.

A version of this article appeared on Medscape.com.

SAN DIEGO — A novel generative artificial intelligence (AI) framework known as trajectory flow matching (TFM) can predict the need for red blood cell transfusion and mortality risk in intensive care unit (ICU) patients with acute gastrointestinal (GI) bleeding, researchers reported at Digestive Disease Week^® (DDW) 2025.

Acute GI bleeding is the most common cause of digestive disease–related hospitalization, with an estimated 500,000 hospital admissions annually. It’s known that predicting the need for red blood cell transfusion in the first 24 hours may improve resuscitation and decrease both morbidity and mortality.

However, an existing clinical score known as the Rockall Score does not perform well for predicting mortality, Xi (Nicole) Zhang, an MD-PhD student at McGill University, Montreal, Quebec, Canada, told attendees at DDW. With an area under the curve of 0.65-0.75, better prediction is needed, said Zhang, whose coresearchers included Dennis Shung, MD, MHS, PhD, director of Applied Artificial Intelligence at Yale University School of Medicine, New Haven, Connecticut.

“We’d like to predict multiple outcomes in addition to mortality,” said Zhang, who is also a student at the Mila-Quebec Artificial Intelligence Institute.

As a result, the researchers turned to the TFM approach, applying it to ICU patients with acute GI bleeding to predict both the need for transfusion and in-hospital mortality risk. The all-cause mortality rate is up to 11%, according to a 2020 study by James Y. W. Lau, MD, and colleagues. The rebleeding rate of nonvariceal upper GI bleeds is up to 10.4%. Zhang said the rebleeding rate for variceal upper gastrointestinal bleeding is up to 65%.

The AI method the researchers used outperformed a standard deep learning model at predicting the need for transfusion and estimating mortality risk.

 

Defining the AI Framework

“Probabilistic flow matching is a class of generative artificial intelligence that learns how a simple distribution becomes a more complex distribution with ordinary differential equations,” Zhang told GI & Hepatology News. “For example, if you had a few lines and shapes you could learn how it could become a detailed portrait of a face. In our case, we start with a few blood pressure and heart rate measurements and learn the pattern of blood pressures and heart rates over time, particularly if they reflect clinical deterioration with hemodynamic instability.”

Another way to think about the underlying algorithm, Zhang said, is to think about a river with boats where the river flow determines where the boats end up. “We are trying to direct the boat to the correct dock by adjusting the flow of water in the canal. In this case we are mapping the distribution with the first few data points to the distribution with the entire patient trajectory.”

The information gained, she said, could be helpful in timing endoscopic evaluation or allocating red blood cell products for emergent transfusion.

 

Study Details

The researchers evaluated a cohort of 2602 patients admitted to the ICU, identified from the publicly available MIMIC-III database. They divided the patients into a training set of 2342 patients and an internal validation set of 260 patients. Input variables were severe liver disease comorbidity, administration of vasopressor medications, mean arterial blood pressure, and heart rate over the first 24 hours.

Excluded was hemoglobin, since the point was to test the trajectory of hemodynamic parameters independent of hemoglobin thresholds used to guide red blood cell transfusion.

The outcome measures were administration of packed red blood cell transfusion within 24 hours and all-cause hospital mortality.

The TFM was more accurate than a standard deep learning model in predicting red blood cell transfusion, with an accuracy of 93.6% vs 43.2%; P ≤ .001. It was also more accurate at predicting all-cause in-hospital mortality, with an accuracy of 89.5% vs 42.5%, P = .01.

The researchers concluded that the TFM approach was able to predict the hemodynamic trajectories of patients with acute GI bleeding defined as deviation and outperformed the baseline from the measured mean arterial pressure and heart rate.

 

Expert Perspective

“This is an exciting proof-of-concept study that shows generative AI methods may be applied to complex datasets in order to improve on our current predictive models and improve patient care,” said Jeremy Glissen Brown, MD, MSc, an assistant professor of medicine and a practicing gastroenterologist at Duke University who has published research on the use of AI in clinical practice. He reviewed the study for GI & Hepatology News but was not involved in the research.

“Future work will likely look into the implementation of a version of this model on real-time data.” he said. “We are at an exciting inflection point in predictive models within GI and clinical medicine. Predictive models based on deep learning and generative AI hold the promise of improving how we predict and treat disease states, but the excitement being generated with studies such as this needs to be balanced with the trade-offs inherent to the current paradigm of deep learning and generative models compared to more traditional regression-based models. These include many of the same ‘black box’ explainability questions that have risen in the age of convolutional neural networks as well as some method-specific questions due to the continuous and implicit nature of TFM.”

Elaborating on that, Glissen Brown said: “TFM, like many deep learning techniques, raises concerns about explainability that we’ve long seen with convolutional neural networks — the ‘black box’ problem, where it’s difficult to interpret exactly how and why the model arrives at a particular decision. But TFM also introduces unique challenges due to its continuous and implicit formulation. Since it often learns flows without explicitly defining intermediate representations or steps, it can be harder to trace the logic or pathways it uses to connect inputs to outputs. This makes standard interpretability tools less effective and calls for new techniques tailored to these continuous architectures.”

“This approach could have a real clinical impact,” said Robert Hirten, MD, associate professor of medicine and artificial intelligence, Icahn School of Medicine at Mount Sinai, New York City, who also reviewed the study. “Accurately predicting transfusion needs and mortality risk in real time could support earlier, more targeted interventions for high-risk patients. While these findings still need to be validated in prospective studies, it could enhance ICU decision-making and resource allocation.”

“For the practicing gastroenterologist, we envision this system could help them figure out when to perform endoscopy in a patient admitted with acute gastrointestinal bleeding in the ICU at very high risk of exsanguination,” Zhang told GI & Hepatology News.

The approach, the researchers said, will be useful in identifying unique patient characteristics, make possible the identification of high-risk patients and lead to more personalized medicine.

Hirten, Zhang, and Shung had no disclosures. Glissen Brown reported consulting relationships with Medtronic, OdinVision, Doximity, and Olympus. The National Institutes of Health funded this study.

A version of this article appeared on Medscape.com.

SAN DIEGO — A real-time, blood-sensing capsule (PillSense) is a safe and effective diagnostic tool for patients with suspected upper gastrointestinal (GI) bleeding that can aid patient triage, reduce unnecessary procedures, and optimize resource use, a study found.

Notably, patients with negative capsule results had shorter hospital stays and lower acuity markers, and in more than one third of cases, an esophagogastroduodenoscopy (EGD) was avoided altogether without any observed adverse events or readmissions, the study team found.

“Our study shows that this novel capsule that detects blood in the upper GI tract (PillSense) was highly sensitive and specific (> 90%) for detecting recent or active upper GI blood, influenced clinical management in 80% of cases and allowed about one third of patients to be safely discharged from the emergency department, with close outpatient follow-up,” Linda Lee, MD, AGAF, medical director of endoscopy, Brigham and Women’s Hospital and associate professor of medicine, Harvard Medical School, Boston, told GI & Hepatology News.

The study was presented at Digestive Disease Week^® (DDW) 2025.

 

Real-World Insights

EGD is the gold standard for diagnosing suspected upper GI bleeding, but limited access to timely EGD complicates diagnosis and resource allocation.

Approved by the US Food and Drug Administration, PillSense (EnteraSense) is an ingestible capsule with a reusable receiver that provides a rapid, noninvasive method for detecting upper GI bleeding. The capsule analyzes light absorption to identify blood and transmits the result within 10 minutes.

Lee and colleagues evaluated the real-world impact of this point-of-care device on clinical triage and resource allocation, while assessing its safety profile.

They analyzed data on 43 patients (mean age 60 years; 72% men) with clinical suspicion of upper GI bleeding in whom the device was used. The most common symptoms were symptomatic anemia (70%), melena (67%), and hematemesis (33%).

Sixteen PillSense studies (37%) were positive for blood detection, and 27 (63%) were negative.

Compared to patients with a positive capsule results, those without blood detected by the capsule had shorter hospital stays (mean, 3.8 vs 13.4 days, P = .02), lower GBS scores (mean, 7.93 vs 12.81; P = .005), and fewer units of blood transfused (mean, 1.19 vs 10.94; P = .01) and were less apt to be hemodynamically unstable (5 vs 8 patients; P = .03).

Capsule results influenced clinical management in 80% of cases, leading to avoidance of EGD in 37% and prioritization of urgent EGD in 18% (all had active bleeding on EGD).

Capsule use improved resource allocation in 51% of cases. This included 12 patients who were discharged from the ED, six who were assigned an inpatient bed early, and four who underwent expedited colonoscopy as upper GI bleeding was ruled out, they noted.

Among the eight patients who did not undergo EGD, there were no readmissions within 30 days and no adverse events. There were no capsule-related adverse events.

“Clinicians should consider using this novel capsule PillSense as another data point in the management of suspected upper GI bleed,” Lee told GI & Hepatology News.

“This could include in helping to triage patients for safe discharge from the ED or to more urgent endoscopy, to differentiate between upper vs lower GI bleed and to manage ICU patients with possible rebleeding,” Lee said.

 

Important Real-World Evidence

Reached for comment, Shahin Ayazi, MD, esophageal surgeon, Director, Allegheny Health Network Chevalier Jackson Esophageal Research Center, Pittsburgh, Pennsylvania, said this study is important for several reasons.

“Prior investigations have established that PillSense possesses a high negative predictive value for detecting upper GI bleeding and have speculated on its utility in triage, decision-making, and potentially avoiding unnecessary endoscopy. This study is important because it substantiates that speculation with clinical data,” Ayazi, who wasn’t involved in the study, told GI & Hepatology News.

“These findings support the capsule’s practical application in patient stratification and clinical workflow, particularly when diagnostic uncertainty is high and endoscopic resources are limited,” Ayazi noted.

In his experience, PillSense is “highly useful as a triage adjunct in the evaluation of suspected upper GI bleeding. It provides direct and objective evidence as to whether blood is currently present in the stomach,” he said.

“In patients whose presentation is ambiguous or whose clinical scores fall into an intermediate risk zone, this binary result can provide clarity that subjective assessment alone may not achieve. This is particularly relevant in settings where the goal is to perform endoscopy within 24 hours, but the volume of consults exceeds procedural capacity,” Ayazi explained.

“In such scenarios, PillSense enables physicians to stratify patients based on objective evidence of active bleeding, helping to prioritize those who require urgent endoscopy and defer or even avoid endoscopic evaluation in those who do not. The result is a more efficient allocation of endoscopic resources without compromising patient safety,” he added.

Ayazi cautioned that the PillSense capsule should not be used as a replacement for clinical evaluation or established risk stratification protocols.

“It is intended for hemodynamically stable patients and has not been validated in cases of active or massive bleeding. Its diagnostic yield depends on the presence of blood in the stomach at the time of capsule transit; intermittent or proximal bleeding that has ceased may not be detected, introducing the potential for false-negative results,” Ayazi told GI & Hepatology News.

“However, in prior studies, the negative predictive value was high, and in the present study, no adverse outcomes were observed in patients who did not undergo endoscopy following a negative PillSense result,” Ayazi noted.

“It must also be understood that PillSense does not localize the source of bleeding or replace endoscopy in patients with a high likelihood of active hemorrhage. It is not designed to detect bleeding from the lower GI tract or distal small bowel. Rather, it serves as an adjunct that can provide immediate clarity when the need for endoscopy is uncertain, and should be interpreted within the broader context of clinical findings, laboratory data, and established risk stratification tools,” he added.

The study had no specific funding. Lee and Ayazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — A real-time, blood-sensing capsule (PillSense) is a safe and effective diagnostic tool for patients with suspected upper gastrointestinal (GI) bleeding that can aid patient triage, reduce unnecessary procedures, and optimize resource use, a study found.

Notably, patients with negative capsule results had shorter hospital stays and lower acuity markers, and in more than one third of cases, an esophagogastroduodenoscopy (EGD) was avoided altogether without any observed adverse events or readmissions, the study team found.

“Our study shows that this novel capsule that detects blood in the upper GI tract (PillSense) was highly sensitive and specific (> 90%) for detecting recent or active upper GI blood, influenced clinical management in 80% of cases and allowed about one third of patients to be safely discharged from the emergency department, with close outpatient follow-up,” Linda Lee, MD, AGAF, medical director of endoscopy, Brigham and Women’s Hospital and associate professor of medicine, Harvard Medical School, Boston, told GI & Hepatology News.

The study was presented at Digestive Disease Week^® (DDW) 2025.

 

Real-World Insights

EGD is the gold standard for diagnosing suspected upper GI bleeding, but limited access to timely EGD complicates diagnosis and resource allocation.

Approved by the US Food and Drug Administration, PillSense (EnteraSense) is an ingestible capsule with a reusable receiver that provides a rapid, noninvasive method for detecting upper GI bleeding. The capsule analyzes light absorption to identify blood and transmits the result within 10 minutes.

Lee and colleagues evaluated the real-world impact of this point-of-care device on clinical triage and resource allocation, while assessing its safety profile.

They analyzed data on 43 patients (mean age 60 years; 72% men) with clinical suspicion of upper GI bleeding in whom the device was used. The most common symptoms were symptomatic anemia (70%), melena (67%), and hematemesis (33%).

Sixteen PillSense studies (37%) were positive for blood detection, and 27 (63%) were negative.

Compared to patients with a positive capsule results, those without blood detected by the capsule had shorter hospital stays (mean, 3.8 vs 13.4 days, P = .02), lower GBS scores (mean, 7.93 vs 12.81; P = .005), and fewer units of blood transfused (mean, 1.19 vs 10.94; P = .01) and were less apt to be hemodynamically unstable (5 vs 8 patients; P = .03).

Capsule results influenced clinical management in 80% of cases, leading to avoidance of EGD in 37% and prioritization of urgent EGD in 18% (all had active bleeding on EGD).

Capsule use improved resource allocation in 51% of cases. This included 12 patients who were discharged from the ED, six who were assigned an inpatient bed early, and four who underwent expedited colonoscopy as upper GI bleeding was ruled out, they noted.

Among the eight patients who did not undergo EGD, there were no readmissions within 30 days and no adverse events. There were no capsule-related adverse events.

“Clinicians should consider using this novel capsule PillSense as another data point in the management of suspected upper GI bleed,” Lee told GI & Hepatology News.

“This could include in helping to triage patients for safe discharge from the ED or to more urgent endoscopy, to differentiate between upper vs lower GI bleed and to manage ICU patients with possible rebleeding,” Lee said.

 

Important Real-World Evidence

Reached for comment, Shahin Ayazi, MD, esophageal surgeon, Director, Allegheny Health Network Chevalier Jackson Esophageal Research Center, Pittsburgh, Pennsylvania, said this study is important for several reasons.

“Prior investigations have established that PillSense possesses a high negative predictive value for detecting upper GI bleeding and have speculated on its utility in triage, decision-making, and potentially avoiding unnecessary endoscopy. This study is important because it substantiates that speculation with clinical data,” Ayazi, who wasn’t involved in the study, told GI & Hepatology News.

“These findings support the capsule’s practical application in patient stratification and clinical workflow, particularly when diagnostic uncertainty is high and endoscopic resources are limited,” Ayazi noted.

In his experience, PillSense is “highly useful as a triage adjunct in the evaluation of suspected upper GI bleeding. It provides direct and objective evidence as to whether blood is currently present in the stomach,” he said.

“In patients whose presentation is ambiguous or whose clinical scores fall into an intermediate risk zone, this binary result can provide clarity that subjective assessment alone may not achieve. This is particularly relevant in settings where the goal is to perform endoscopy within 24 hours, but the volume of consults exceeds procedural capacity,” Ayazi explained.

“In such scenarios, PillSense enables physicians to stratify patients based on objective evidence of active bleeding, helping to prioritize those who require urgent endoscopy and defer or even avoid endoscopic evaluation in those who do not. The result is a more efficient allocation of endoscopic resources without compromising patient safety,” he added.

Ayazi cautioned that the PillSense capsule should not be used as a replacement for clinical evaluation or established risk stratification protocols.

“It is intended for hemodynamically stable patients and has not been validated in cases of active or massive bleeding. Its diagnostic yield depends on the presence of blood in the stomach at the time of capsule transit; intermittent or proximal bleeding that has ceased may not be detected, introducing the potential for false-negative results,” Ayazi told GI & Hepatology News.

“However, in prior studies, the negative predictive value was high, and in the present study, no adverse outcomes were observed in patients who did not undergo endoscopy following a negative PillSense result,” Ayazi noted.

“It must also be understood that PillSense does not localize the source of bleeding or replace endoscopy in patients with a high likelihood of active hemorrhage. It is not designed to detect bleeding from the lower GI tract or distal small bowel. Rather, it serves as an adjunct that can provide immediate clarity when the need for endoscopy is uncertain, and should be interpreted within the broader context of clinical findings, laboratory data, and established risk stratification tools,” he added.

The study had no specific funding. Lee and Ayazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — A real-time, blood-sensing capsule (PillSense) is a safe and effective diagnostic tool for patients with suspected upper gastrointestinal (GI) bleeding that can aid patient triage, reduce unnecessary procedures, and optimize resource use, a study found.

Notably, patients with negative capsule results had shorter hospital stays and lower acuity markers, and in more than one third of cases, an esophagogastroduodenoscopy (EGD) was avoided altogether without any observed adverse events or readmissions, the study team found.

“Our study shows that this novel capsule that detects blood in the upper GI tract (PillSense) was highly sensitive and specific (> 90%) for detecting recent or active upper GI blood, influenced clinical management in 80% of cases and allowed about one third of patients to be safely discharged from the emergency department, with close outpatient follow-up,” Linda Lee, MD, AGAF, medical director of endoscopy, Brigham and Women’s Hospital and associate professor of medicine, Harvard Medical School, Boston, told GI & Hepatology News.

The study was presented at Digestive Disease Week^® (DDW) 2025.

 

Real-World Insights

EGD is the gold standard for diagnosing suspected upper GI bleeding, but limited access to timely EGD complicates diagnosis and resource allocation.

Approved by the US Food and Drug Administration, PillSense (EnteraSense) is an ingestible capsule with a reusable receiver that provides a rapid, noninvasive method for detecting upper GI bleeding. The capsule analyzes light absorption to identify blood and transmits the result within 10 minutes.

Lee and colleagues evaluated the real-world impact of this point-of-care device on clinical triage and resource allocation, while assessing its safety profile.

They analyzed data on 43 patients (mean age 60 years; 72% men) with clinical suspicion of upper GI bleeding in whom the device was used. The most common symptoms were symptomatic anemia (70%), melena (67%), and hematemesis (33%).

Sixteen PillSense studies (37%) were positive for blood detection, and 27 (63%) were negative.

Compared to patients with a positive capsule results, those without blood detected by the capsule had shorter hospital stays (mean, 3.8 vs 13.4 days, P = .02), lower GBS scores (mean, 7.93 vs 12.81; P = .005), and fewer units of blood transfused (mean, 1.19 vs 10.94; P = .01) and were less apt to be hemodynamically unstable (5 vs 8 patients; P = .03).

Capsule results influenced clinical management in 80% of cases, leading to avoidance of EGD in 37% and prioritization of urgent EGD in 18% (all had active bleeding on EGD).

Capsule use improved resource allocation in 51% of cases. This included 12 patients who were discharged from the ED, six who were assigned an inpatient bed early, and four who underwent expedited colonoscopy as upper GI bleeding was ruled out, they noted.

Among the eight patients who did not undergo EGD, there were no readmissions within 30 days and no adverse events. There were no capsule-related adverse events.

“Clinicians should consider using this novel capsule PillSense as another data point in the management of suspected upper GI bleed,” Lee told GI & Hepatology News.

“This could include in helping to triage patients for safe discharge from the ED or to more urgent endoscopy, to differentiate between upper vs lower GI bleed and to manage ICU patients with possible rebleeding,” Lee said.

 

Important Real-World Evidence

Reached for comment, Shahin Ayazi, MD, esophageal surgeon, Director, Allegheny Health Network Chevalier Jackson Esophageal Research Center, Pittsburgh, Pennsylvania, said this study is important for several reasons.

“Prior investigations have established that PillSense possesses a high negative predictive value for detecting upper GI bleeding and have speculated on its utility in triage, decision-making, and potentially avoiding unnecessary endoscopy. This study is important because it substantiates that speculation with clinical data,” Ayazi, who wasn’t involved in the study, told GI & Hepatology News.

“These findings support the capsule’s practical application in patient stratification and clinical workflow, particularly when diagnostic uncertainty is high and endoscopic resources are limited,” Ayazi noted.

In his experience, PillSense is “highly useful as a triage adjunct in the evaluation of suspected upper GI bleeding. It provides direct and objective evidence as to whether blood is currently present in the stomach,” he said.

“In patients whose presentation is ambiguous or whose clinical scores fall into an intermediate risk zone, this binary result can provide clarity that subjective assessment alone may not achieve. This is particularly relevant in settings where the goal is to perform endoscopy within 24 hours, but the volume of consults exceeds procedural capacity,” Ayazi explained.

“In such scenarios, PillSense enables physicians to stratify patients based on objective evidence of active bleeding, helping to prioritize those who require urgent endoscopy and defer or even avoid endoscopic evaluation in those who do not. The result is a more efficient allocation of endoscopic resources without compromising patient safety,” he added.

Ayazi cautioned that the PillSense capsule should not be used as a replacement for clinical evaluation or established risk stratification protocols.

“It is intended for hemodynamically stable patients and has not been validated in cases of active or massive bleeding. Its diagnostic yield depends on the presence of blood in the stomach at the time of capsule transit; intermittent or proximal bleeding that has ceased may not be detected, introducing the potential for false-negative results,” Ayazi told GI & Hepatology News.

“However, in prior studies, the negative predictive value was high, and in the present study, no adverse outcomes were observed in patients who did not undergo endoscopy following a negative PillSense result,” Ayazi noted.

“It must also be understood that PillSense does not localize the source of bleeding or replace endoscopy in patients with a high likelihood of active hemorrhage. It is not designed to detect bleeding from the lower GI tract or distal small bowel. Rather, it serves as an adjunct that can provide immediate clarity when the need for endoscopy is uncertain, and should be interpreted within the broader context of clinical findings, laboratory data, and established risk stratification tools,” he added.

The study had no specific funding. Lee and Ayazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO—Gastroenterologists have debated the best course of action for patients with Barrett’s esophagus for decades. Which is better for detecting early malignancy and preventing progression to esophageal adenocarcinoma (EAC) — surveillance endoscopy at regular intervals or only when symptoms occur? Does one offer a better chance of survival than the other?

Now, researchers who conducted what they believe is the first randomized clinical trial comparing the two approaches say they have the answer.

Surveillance endoscopy every 2 years offers no benefit in terms of overall or cancer-specific survival, said Oliver Old, MD, a consultant upper-GI surgeon at Gloucestershire Royal Hospital, England, who presented the findings at Digestive Disease Week^® (DDW) 2025.

At-need endoscopy may be a safe alternative for low-risk patients, the research team concluded.

 

The BOSS Trial

The Barrett’s Oesophagus Surveillance Versus Endoscopy At Need Study (BOSS) ran from 2009 to 2024 at 109 centers in the UK, and 3452 patients with Barrett’s esophagus of 1 cm circumferential or a 2 cm noncircumferential tongue or island were followed for a minimum of 10 years.

Researchers randomly assigned patients to undergo upper gastrointestinal endoscopy with biopsy every 2 years (the standard of care when the trial was set up) or endoscopy “at-need” when symptoms developed. Patients in the latter group were counseled about risk and were offered endoscopy for a range of alarm symptoms.

The study found no statistically significant difference in all-cause mortality risk between the two groups. Over the study period, 333 of 1733 patients (19.2%) in the surveillance group died, as did 356 of 1719 patients (20.7%) in the at-need group.

Similarly, no statistically significant between-group difference was found in the risk for cancer-specific mortality. About 6.2% of patients died from cancer in both groups — 108 in the regular surveillance group and 106 in the at-need group.

Nor was there a statistically significant difference in diagnosis of EAC, with 40 regular surveillance patients (2.3%) and 31 at-need patients (1.8%) receiving the diagnosis over median follow-up of 12.8 years. Cancer stage at diagnosis did not differ significantly between groups.

“The really low rate of progression to esophageal adenocarcinoma” was a key finding, Old said. The rate of progression to EAC was 0.23% per patient per year, he said.

Low- or high-grade dysplasia was detected in 10% of patients in the regular surveillance group, compared with 4% in the at-need group.

The mean interval between endoscopies was 22.9 months for the regular surveillance group and 31.5 months for the at-need group, and the median interval was 24.8 months and 25.7 months, respectively. The mean number of endoscopies was 3.5 in the regular surveillance group and 1.4 in the at-need group.

Eight patients in the regular surveillance group (0.46%) and seven in the at-need group (0.41%) reported serious adverse events.

 

Will BOSS Change Minds?

Current surveillance practices “are based on pure observational data, and the question of whether surveillance EGD [esophagogastroduodenoscopy] impacts EAC diagnosis and mortality has been ongoing,” said Margaret Zhou, MD, MS, clinical assistant professor at Stanford University School of Medicine, Stanford, California. A randomized clinical trial on the subject has been needed for years, she added.

However, Zhou said, “In my opinion, this study does not end the debate and will not change my practice of doing surveillance endoscopy on NDBE [nondysplastic Barrett’s esophagus], which I typically perform every 3-5 years, based on current guidelines.”

The American Gastroenterological Association clinical practice guideline, issued in June 2024, addresses surveillance and focuses on a patient-centered approach when deciding on treatment or surveillance.

Patients in the at-need endoscopy arm underwent endoscopy almost as frequently as the patients randomly assigned to regular surveillance, at a median interval of about 2 years, Zhou noted. Therefore, she said, “It’s difficult to conclude from this study that surveillance endoscopy has no impact.”

Additionally, the study was underpowered to detect a difference in all-cause mortality and assumed a progression rate for nondysplastic Barrett’s esophagus that is higher than the current understanding, Zhou said. “It also did not address the important question of EAC-related mortality, which would be an important outcome to be able to assess whether surveillance EGD has an impact,” she said.

Joel H. Rubenstein, MD, MSc, AGAF, director of the Barrett’s Esophagus Program and professor in the Division of Gastroenterology at the University of Michigan Medical School, Ann Arbor, agreed that the study doesn’t answer the pressing question of whether surveillance works.

While Rubenstein said he would not tell colleagues or patients to stop routine surveillance in patients with Barrett’s esophagus on the basis of these results, “it is a reminder that we should be circumspect in who we label as having Barrett’s esophagus, and we should be more proactive in discussing discontinuation of surveillance in patients based on advancing age and comorbidities.”

The study was funded by the UK’s National Institute for Health and Care Research. Zhou is a consultant for CapsoVision and Neptune Medical. Rubenstein has received research funding from Lucid Diagnostics. Old reported no disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO—Gastroenterologists have debated the best course of action for patients with Barrett’s esophagus for decades. Which is better for detecting early malignancy and preventing progression to esophageal adenocarcinoma (EAC) — surveillance endoscopy at regular intervals or only when symptoms occur? Does one offer a better chance of survival than the other?

Now, researchers who conducted what they believe is the first randomized clinical trial comparing the two approaches say they have the answer.

Surveillance endoscopy every 2 years offers no benefit in terms of overall or cancer-specific survival, said Oliver Old, MD, a consultant upper-GI surgeon at Gloucestershire Royal Hospital, England, who presented the findings at Digestive Disease Week^® (DDW) 2025.

At-need endoscopy may be a safe alternative for low-risk patients, the research team concluded.

 

The BOSS Trial

The Barrett’s Oesophagus Surveillance Versus Endoscopy At Need Study (BOSS) ran from 2009 to 2024 at 109 centers in the UK, and 3452 patients with Barrett’s esophagus of 1 cm circumferential or a 2 cm noncircumferential tongue or island were followed for a minimum of 10 years.

Researchers randomly assigned patients to undergo upper gastrointestinal endoscopy with biopsy every 2 years (the standard of care when the trial was set up) or endoscopy “at-need” when symptoms developed. Patients in the latter group were counseled about risk and were offered endoscopy for a range of alarm symptoms.

The study found no statistically significant difference in all-cause mortality risk between the two groups. Over the study period, 333 of 1733 patients (19.2%) in the surveillance group died, as did 356 of 1719 patients (20.7%) in the at-need group.

Similarly, no statistically significant between-group difference was found in the risk for cancer-specific mortality. About 6.2% of patients died from cancer in both groups — 108 in the regular surveillance group and 106 in the at-need group.

Nor was there a statistically significant difference in diagnosis of EAC, with 40 regular surveillance patients (2.3%) and 31 at-need patients (1.8%) receiving the diagnosis over median follow-up of 12.8 years. Cancer stage at diagnosis did not differ significantly between groups.

“The really low rate of progression to esophageal adenocarcinoma” was a key finding, Old said. The rate of progression to EAC was 0.23% per patient per year, he said.

Low- or high-grade dysplasia was detected in 10% of patients in the regular surveillance group, compared with 4% in the at-need group.

The mean interval between endoscopies was 22.9 months for the regular surveillance group and 31.5 months for the at-need group, and the median interval was 24.8 months and 25.7 months, respectively. The mean number of endoscopies was 3.5 in the regular surveillance group and 1.4 in the at-need group.

Eight patients in the regular surveillance group (0.46%) and seven in the at-need group (0.41%) reported serious adverse events.

 

Will BOSS Change Minds?

Current surveillance practices “are based on pure observational data, and the question of whether surveillance EGD [esophagogastroduodenoscopy] impacts EAC diagnosis and mortality has been ongoing,” said Margaret Zhou, MD, MS, clinical assistant professor at Stanford University School of Medicine, Stanford, California. A randomized clinical trial on the subject has been needed for years, she added.

However, Zhou said, “In my opinion, this study does not end the debate and will not change my practice of doing surveillance endoscopy on NDBE [nondysplastic Barrett’s esophagus], which I typically perform every 3-5 years, based on current guidelines.”

The American Gastroenterological Association clinical practice guideline, issued in June 2024, addresses surveillance and focuses on a patient-centered approach when deciding on treatment or surveillance.

Patients in the at-need endoscopy arm underwent endoscopy almost as frequently as the patients randomly assigned to regular surveillance, at a median interval of about 2 years, Zhou noted. Therefore, she said, “It’s difficult to conclude from this study that surveillance endoscopy has no impact.”

Additionally, the study was underpowered to detect a difference in all-cause mortality and assumed a progression rate for nondysplastic Barrett’s esophagus that is higher than the current understanding, Zhou said. “It also did not address the important question of EAC-related mortality, which would be an important outcome to be able to assess whether surveillance EGD has an impact,” she said.

Joel H. Rubenstein, MD, MSc, AGAF, director of the Barrett’s Esophagus Program and professor in the Division of Gastroenterology at the University of Michigan Medical School, Ann Arbor, agreed that the study doesn’t answer the pressing question of whether surveillance works.

While Rubenstein said he would not tell colleagues or patients to stop routine surveillance in patients with Barrett’s esophagus on the basis of these results, “it is a reminder that we should be circumspect in who we label as having Barrett’s esophagus, and we should be more proactive in discussing discontinuation of surveillance in patients based on advancing age and comorbidities.”

The study was funded by the UK’s National Institute for Health and Care Research. Zhou is a consultant for CapsoVision and Neptune Medical. Rubenstein has received research funding from Lucid Diagnostics. Old reported no disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO—Gastroenterologists have debated the best course of action for patients with Barrett’s esophagus for decades. Which is better for detecting early malignancy and preventing progression to esophageal adenocarcinoma (EAC) — surveillance endoscopy at regular intervals or only when symptoms occur? Does one offer a better chance of survival than the other?

Now, researchers who conducted what they believe is the first randomized clinical trial comparing the two approaches say they have the answer.

Surveillance endoscopy every 2 years offers no benefit in terms of overall or cancer-specific survival, said Oliver Old, MD, a consultant upper-GI surgeon at Gloucestershire Royal Hospital, England, who presented the findings at Digestive Disease Week^® (DDW) 2025.

At-need endoscopy may be a safe alternative for low-risk patients, the research team concluded.

 

The BOSS Trial

The Barrett’s Oesophagus Surveillance Versus Endoscopy At Need Study (BOSS) ran from 2009 to 2024 at 109 centers in the UK, and 3452 patients with Barrett’s esophagus of 1 cm circumferential or a 2 cm noncircumferential tongue or island were followed for a minimum of 10 years.

Researchers randomly assigned patients to undergo upper gastrointestinal endoscopy with biopsy every 2 years (the standard of care when the trial was set up) or endoscopy “at-need” when symptoms developed. Patients in the latter group were counseled about risk and were offered endoscopy for a range of alarm symptoms.

The study found no statistically significant difference in all-cause mortality risk between the two groups. Over the study period, 333 of 1733 patients (19.2%) in the surveillance group died, as did 356 of 1719 patients (20.7%) in the at-need group.

Similarly, no statistically significant between-group difference was found in the risk for cancer-specific mortality. About 6.2% of patients died from cancer in both groups — 108 in the regular surveillance group and 106 in the at-need group.

Nor was there a statistically significant difference in diagnosis of EAC, with 40 regular surveillance patients (2.3%) and 31 at-need patients (1.8%) receiving the diagnosis over median follow-up of 12.8 years. Cancer stage at diagnosis did not differ significantly between groups.

“The really low rate of progression to esophageal adenocarcinoma” was a key finding, Old said. The rate of progression to EAC was 0.23% per patient per year, he said.

Low- or high-grade dysplasia was detected in 10% of patients in the regular surveillance group, compared with 4% in the at-need group.

The mean interval between endoscopies was 22.9 months for the regular surveillance group and 31.5 months for the at-need group, and the median interval was 24.8 months and 25.7 months, respectively. The mean number of endoscopies was 3.5 in the regular surveillance group and 1.4 in the at-need group.

Eight patients in the regular surveillance group (0.46%) and seven in the at-need group (0.41%) reported serious adverse events.

 

Will BOSS Change Minds?

Current surveillance practices “are based on pure observational data, and the question of whether surveillance EGD [esophagogastroduodenoscopy] impacts EAC diagnosis and mortality has been ongoing,” said Margaret Zhou, MD, MS, clinical assistant professor at Stanford University School of Medicine, Stanford, California. A randomized clinical trial on the subject has been needed for years, she added.

However, Zhou said, “In my opinion, this study does not end the debate and will not change my practice of doing surveillance endoscopy on NDBE [nondysplastic Barrett’s esophagus], which I typically perform every 3-5 years, based on current guidelines.”

The American Gastroenterological Association clinical practice guideline, issued in June 2024, addresses surveillance and focuses on a patient-centered approach when deciding on treatment or surveillance.

Patients in the at-need endoscopy arm underwent endoscopy almost as frequently as the patients randomly assigned to regular surveillance, at a median interval of about 2 years, Zhou noted. Therefore, she said, “It’s difficult to conclude from this study that surveillance endoscopy has no impact.”

Additionally, the study was underpowered to detect a difference in all-cause mortality and assumed a progression rate for nondysplastic Barrett’s esophagus that is higher than the current understanding, Zhou said. “It also did not address the important question of EAC-related mortality, which would be an important outcome to be able to assess whether surveillance EGD has an impact,” she said.

Joel H. Rubenstein, MD, MSc, AGAF, director of the Barrett’s Esophagus Program and professor in the Division of Gastroenterology at the University of Michigan Medical School, Ann Arbor, agreed that the study doesn’t answer the pressing question of whether surveillance works.

While Rubenstein said he would not tell colleagues or patients to stop routine surveillance in patients with Barrett’s esophagus on the basis of these results, “it is a reminder that we should be circumspect in who we label as having Barrett’s esophagus, and we should be more proactive in discussing discontinuation of surveillance in patients based on advancing age and comorbidities.”

The study was funded by the UK’s National Institute for Health and Care Research. Zhou is a consultant for CapsoVision and Neptune Medical. Rubenstein has received research funding from Lucid Diagnostics. Old reported no disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO – Advanced practice providers (APPs) can be trained to perform transnasal endoscopy (TNE) with a single-use ultra-slim gastroscope with only topical anesthesia, a pilot study showed.

“Our study showed that TNE can be performed safely by APPs, is well tolerated by patients, and significantly impacted patient management,” Whitney Kucher, PA-C, with Northwestern Medicine, Chicago, told GI & Hepatology News.

“The chief benefit of having APPs perform TNEs is increasing patient access and expediting management of upper GI [gastrointestinal] symptoms in patients,” said Kucher who presented the study at Digestive Disease Week® (DDW) 2025.

The EvoEndo single-use endoscopy system received 510(k) clearance from the US Food and Drug Administration in early 2022.

The system includes a sterile, single-use, flexible gastroscope designed for unsedated transnasal upper endoscopy and a small portable video controller.

Unsedated TNE can be used to evaluate and diagnose a wide range of upper GI conditions that may require frequent monitoring, including eosinophilic esophagitis (EoE), dysphagia, celiac disease, gastroesophageal reflux disease (GERD), Barrett’s esophagus (BE), malabsorption, and abdominal pain.

Kucher and colleagues assessed the ability for APPs to use the EvoEndo system to perform safe and accurate esophageal assessment using in-office TNE, following training.

TNE training lasted about 4 weeks and consisted of a stepwise approach involving lectures, simulation-based training, and hands-on supervised TNEs (10 per APP).

Once training was completed, and after providing consent, 25 patients were enrolled to undergo supervised TNE by an APP. Their mean age was 55 years, and 58% were women.

Indications for TNE were uncontrolled GERD symptoms in 12 patients, history of EoE in six patients, high-risk screening for BE in five patients, and dysphagia in two patients.

Technical success was achieved in all but one patient (96%), and there were no adverse events.

All 25 patients completed the procedure, with 17 (72%) giving it a TNEase score of 1 (with ease/no discomfort) or 2 (mild/occasional discomfort). Only two patients reported a score of 4 (very uncomfortable) but still completed the exam.

The average TNE procedure time was 7.3 minutes.

TNE findings changed management in 23 of 25 (92%) patients. The test led to a change in proton pump inhibitor dosing or interval in 14 patients (56%). Esophagogastroduodenoscopy (EGD) interval was extended in five patients (20%) and scheduled sooner in three patients (12%). Two patients (8%) had no change in management.

The study team said more data are needed in terms of learning curves, competency metrics, and health economics before widespread adoption can be supported.

“We are working on developing a standardized training plan so we can train more GI APPs in our department. We have plans to start an APP-driven TNE program in the coming months,” Kucher told GI & Hepatology News.

 

Caveats and Cautionary Notes

Commenting on this study for GI & Hepatology News, Amitabh Chak, MD, professor of medicine and oncology at Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, both in Cleveland, noted that the results are “similar to older studies where TNE appeared quite promising and APPs could be trained. There have been previous studies that APPs can perform colonoscopies and EGDs.”

Chak cautioned that previous studies showed that it took at least 50 supervised examinations for APPs to achieve the needed skills.

“Intubation transnasally can be painful for patients if not done with skill. Cognitive skills take longer. The gastroesophageal junction is dynamic, and recognition of subtle pathology takes training,” Chak noted.

“TNE has been around at least two decades. The challenge with uptake of TNE for Barrett’s screening has been acceptance by primary care physicians, patients and payers,” Chak told GI & Hepatology News.

The study had no specific funding. Kucher reported having no relevant disclosures. Chak reported having relationships with US Endoscopy, Lucid Diagnostics, Steris Endoscopy/US Endoscopy, Microtek, and Interpace Diagnostics.

A version of this article appeared on Medscape.com.

SAN DIEGO – Advanced practice providers (APPs) can be trained to perform transnasal endoscopy (TNE) with a single-use ultra-slim gastroscope with only topical anesthesia, a pilot study showed.

“Our study showed that TNE can be performed safely by APPs, is well tolerated by patients, and significantly impacted patient management,” Whitney Kucher, PA-C, with Northwestern Medicine, Chicago, told GI & Hepatology News.

“The chief benefit of having APPs perform TNEs is increasing patient access and expediting management of upper GI [gastrointestinal] symptoms in patients,” said Kucher who presented the study at Digestive Disease Week® (DDW) 2025.

The EvoEndo single-use endoscopy system received 510(k) clearance from the US Food and Drug Administration in early 2022.

The system includes a sterile, single-use, flexible gastroscope designed for unsedated transnasal upper endoscopy and a small portable video controller.

Unsedated TNE can be used to evaluate and diagnose a wide range of upper GI conditions that may require frequent monitoring, including eosinophilic esophagitis (EoE), dysphagia, celiac disease, gastroesophageal reflux disease (GERD), Barrett’s esophagus (BE), malabsorption, and abdominal pain.

Kucher and colleagues assessed the ability for APPs to use the EvoEndo system to perform safe and accurate esophageal assessment using in-office TNE, following training.

TNE training lasted about 4 weeks and consisted of a stepwise approach involving lectures, simulation-based training, and hands-on supervised TNEs (10 per APP).

Once training was completed, and after providing consent, 25 patients were enrolled to undergo supervised TNE by an APP. Their mean age was 55 years, and 58% were women.

Indications for TNE were uncontrolled GERD symptoms in 12 patients, history of EoE in six patients, high-risk screening for BE in five patients, and dysphagia in two patients.

Technical success was achieved in all but one patient (96%), and there were no adverse events.

All 25 patients completed the procedure, with 17 (72%) giving it a TNEase score of 1 (with ease/no discomfort) or 2 (mild/occasional discomfort). Only two patients reported a score of 4 (very uncomfortable) but still completed the exam.

The average TNE procedure time was 7.3 minutes.

TNE findings changed management in 23 of 25 (92%) patients. The test led to a change in proton pump inhibitor dosing or interval in 14 patients (56%). Esophagogastroduodenoscopy (EGD) interval was extended in five patients (20%) and scheduled sooner in three patients (12%). Two patients (8%) had no change in management.

The study team said more data are needed in terms of learning curves, competency metrics, and health economics before widespread adoption can be supported.

“We are working on developing a standardized training plan so we can train more GI APPs in our department. We have plans to start an APP-driven TNE program in the coming months,” Kucher told GI & Hepatology News.

 

Caveats and Cautionary Notes

Commenting on this study for GI & Hepatology News, Amitabh Chak, MD, professor of medicine and oncology at Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, both in Cleveland, noted that the results are “similar to older studies where TNE appeared quite promising and APPs could be trained. There have been previous studies that APPs can perform colonoscopies and EGDs.”

Chak cautioned that previous studies showed that it took at least 50 supervised examinations for APPs to achieve the needed skills.

“Intubation transnasally can be painful for patients if not done with skill. Cognitive skills take longer. The gastroesophageal junction is dynamic, and recognition of subtle pathology takes training,” Chak noted.

“TNE has been around at least two decades. The challenge with uptake of TNE for Barrett’s screening has been acceptance by primary care physicians, patients and payers,” Chak told GI & Hepatology News.

The study had no specific funding. Kucher reported having no relevant disclosures. Chak reported having relationships with US Endoscopy, Lucid Diagnostics, Steris Endoscopy/US Endoscopy, Microtek, and Interpace Diagnostics.

A version of this article appeared on Medscape.com.

SAN DIEGO – Advanced practice providers (APPs) can be trained to perform transnasal endoscopy (TNE) with a single-use ultra-slim gastroscope with only topical anesthesia, a pilot study showed.

“Our study showed that TNE can be performed safely by APPs, is well tolerated by patients, and significantly impacted patient management,” Whitney Kucher, PA-C, with Northwestern Medicine, Chicago, told GI & Hepatology News.

“The chief benefit of having APPs perform TNEs is increasing patient access and expediting management of upper GI [gastrointestinal] symptoms in patients,” said Kucher who presented the study at Digestive Disease Week® (DDW) 2025.

The EvoEndo single-use endoscopy system received 510(k) clearance from the US Food and Drug Administration in early 2022.

The system includes a sterile, single-use, flexible gastroscope designed for unsedated transnasal upper endoscopy and a small portable video controller.

Unsedated TNE can be used to evaluate and diagnose a wide range of upper GI conditions that may require frequent monitoring, including eosinophilic esophagitis (EoE), dysphagia, celiac disease, gastroesophageal reflux disease (GERD), Barrett’s esophagus (BE), malabsorption, and abdominal pain.

Kucher and colleagues assessed the ability for APPs to use the EvoEndo system to perform safe and accurate esophageal assessment using in-office TNE, following training.

TNE training lasted about 4 weeks and consisted of a stepwise approach involving lectures, simulation-based training, and hands-on supervised TNEs (10 per APP).

Once training was completed, and after providing consent, 25 patients were enrolled to undergo supervised TNE by an APP. Their mean age was 55 years, and 58% were women.

Indications for TNE were uncontrolled GERD symptoms in 12 patients, history of EoE in six patients, high-risk screening for BE in five patients, and dysphagia in two patients.

Technical success was achieved in all but one patient (96%), and there were no adverse events.

All 25 patients completed the procedure, with 17 (72%) giving it a TNEase score of 1 (with ease/no discomfort) or 2 (mild/occasional discomfort). Only two patients reported a score of 4 (very uncomfortable) but still completed the exam.

The average TNE procedure time was 7.3 minutes.

TNE findings changed management in 23 of 25 (92%) patients. The test led to a change in proton pump inhibitor dosing or interval in 14 patients (56%). Esophagogastroduodenoscopy (EGD) interval was extended in five patients (20%) and scheduled sooner in three patients (12%). Two patients (8%) had no change in management.

The study team said more data are needed in terms of learning curves, competency metrics, and health economics before widespread adoption can be supported.

“We are working on developing a standardized training plan so we can train more GI APPs in our department. We have plans to start an APP-driven TNE program in the coming months,” Kucher told GI & Hepatology News.

 

Caveats and Cautionary Notes

Commenting on this study for GI & Hepatology News, Amitabh Chak, MD, professor of medicine and oncology at Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, both in Cleveland, noted that the results are “similar to older studies where TNE appeared quite promising and APPs could be trained. There have been previous studies that APPs can perform colonoscopies and EGDs.”

Chak cautioned that previous studies showed that it took at least 50 supervised examinations for APPs to achieve the needed skills.

“Intubation transnasally can be painful for patients if not done with skill. Cognitive skills take longer. The gastroesophageal junction is dynamic, and recognition of subtle pathology takes training,” Chak noted.

“TNE has been around at least two decades. The challenge with uptake of TNE for Barrett’s screening has been acceptance by primary care physicians, patients and payers,” Chak told GI & Hepatology News.

The study had no specific funding. Kucher reported having no relevant disclosures. Chak reported having relationships with US Endoscopy, Lucid Diagnostics, Steris Endoscopy/US Endoscopy, Microtek, and Interpace Diagnostics.

A version of this article appeared on Medscape.com.

SAN DIEGO – A novel investigational endoscopic procedure targeting the duodenum appears beneficial in improving glycemic parameters in people with type 2 diabetes (T2D).

In a new dose-finding study, the re-cellularization via electroporation therapy (ReCET, Endogenex) improved insulin sensitivity, beta-cell function, and other glycemic parameters at 12 and 48 weeks in 51 individuals with T2D. “The findings suggest that duodenal mucosal and submucosal recellularization are key therapeutic targets in type 2 diabetes management,” said Barham Abu Dayyeh, MD, director of Interventional Gastroenterology at Cedar-Sinai Hospital, Los Angeles, in a presentation at Digestive Disease Week (DDW) 2025.

The outpatient technique is based on pulsed electrical fields, or electroporation, which do not use heat. “It’s nonthermal regeneration, not just ablation. It’s regeneration of the duodenum as a treatment target that could potentially modify type 2 diabetes,” Abu Dayyeh told GI & Hepatology News.

Separately at DDW, Abu Dayyeh presented results from an artificial intelligence–based analysis of duodenal biopsies from 111 individuals with T2D and 120 control individuals without diabetes, demonstrating distinct mucosal features associated with metabolic disease, significant inflammation in the deep mucosa and submucosa with increased fibrosis, and gut-barrier dysfunction. The authors termed this set of abnormalities “diabetic duodenopathy.” 

Abu Dayyeh likened the duodenum to a “conductor” of the “dysfunctional orchestra” of metabolic disease that includes T2D. “It’s tasked with integrating signals from the food that we eat and from our microbiome and communicates that metabolic response to downstream organs like the pancreas, liver, and adipose tissue.”

Currently, he said, “We use treatments that work downstream on components of this dysfunctional orchestra. So we work on the violinist and the flute player, but we do not go upstream to say maybe there’s an opportunity to put the orchestra conductor back in synch…We manage blood glycemia by lowering it, rather than looking at upstream disease-modifying targets that could reverse the course so you require less insulin and less medication.” 

Abu Dayyeh envisions the ReCET procedure as an option for people struggling to control T2D with standard medications, or for early use to avoid or delay medications, particularly insulin. But it won’t replace medications. “On the contrary, I see it as enhancing and complementing medications,” he said.

Asked to comment, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, Cleveland, Ohio, told GI & Hepatology News, “Diabetes is a heterogeneous disease complex with numerous pathophysiological derangements. Although diabetic duodenopathy can be seen in some patients with diabetes, that wouldn’t explain the entire story behind diabetes pathogenesis in all people with diabetes. In a subgroup of people with duodenal involvement in their disease process, endoscopic procedures targeting the duodenum may play a role in the future.”

 

Glycemic Parameters Improve Following ReCET Procedure

The new study, called REGENT-1, was a multicenter, open-label, single-arm dose escalation of three levels of energy delivery in patients who had T2D for 10 years or less with A1c levels 7.5%-11% despite the use of one or more noninsulin glucose-lowering medications. Procedural success, defined as treatment of at least 6 cm of duodenum, was achieved in 100% of participants.

From a baseline A1c of 8.6%, there were dose-response drops at weeks 12 and 48 by energy delivery, with significant reductions at week 48 of 1.00 and 1.70 percentage points, respectively, among the 18 who received the middle dose and the 21 given the highest dose. Body weight also dropped in all three groups in a dose-response way, from 1.2% with the lowest to 6.2% with the highest energy delivery.

In mixed-meal tolerance testing, glucose area under the curve, homeostatic model assessment for insulin resistance, sensitivity index, beta-cell function, and disposition index (a measure of beta-cell response to insulin resistance) were all reduced from baseline at 48 weeks after ReCET, reaching statistical significance with the highest energy dose.

There were no device- or procedure-related serious adverse events.

Based on a literature search, Abu Dayyeh found that modern glucagon like peptide-1 receptor agonist medications have a stronger effect than ReCET or Roux-en-Y gastric bypass (RYGB) on beta-cell function (increases by 239% with semaglutide and 314% with tirzepatide vs 50% with ReCET and 74% for RYGB). However, ReCET procedure produced superior results for both insulin sensitivity (+487% for ReCET and +326% for bypass vs 30% and 62%, respectively for semaglutide and tirzepatide) and disposition index (+1032% for ReCET, +667% with tirzepatide, +642% for RYGB, and +367% for semaglutide).

Aminian commented, “The findings of this single arm clinical trial are promising. The next step is to incorporate a blinded control group who undergoes an endoscopy without any therapeutic intervention.”

In fact, such a study is underway. Results of “a multicenter, randomized, double-blind, sham-controlled study for assessing the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (ReCET)” are expected in late 2026.

In the meantime, Amanian said about the current findings, “I’d argue that the observed improvement in diabetes parameters can be related to more intensive medical therapy during follow-up in this single arm study.”

In the trials, the procedure takes 30 minutes to an hour to perform. However, as the technology improves, “the vision of this is to be a 20-minute outpatient procedure eventually,” Abu Dayyeh said.

He envisions that eventually the procedure will become as accessible as colonoscopy is now, and that primary care physicians and endocrinologists would similarly refer patients to a gastroenterologist or surgeon to have it done. “They do the procedure and send your patient back, hopefully with a less complex management strategy, so you could manage them more efficiently without escalating care.” 

Abu Dayyeh is a co-inventor of the ReCET procedure, with the technology licensed by the Mayo Clinic. He is a consultant for and/or reported receiving research support from Boston Scientific, Olympus, Medtronic, Metamodix, BFKW, Apollo Endosurgery, USGI, Endogastric Solutions, Spatz, and Cairn. Aminian had received grants and personal fees from Medtronic and Ethicon. He serves as a consultant for Medtronic, Ethicon, and Eli Lilly.

A version of this article appeared on Medscape.com.

SAN DIEGO – A novel investigational endoscopic procedure targeting the duodenum appears beneficial in improving glycemic parameters in people with type 2 diabetes (T2D).

In a new dose-finding study, the re-cellularization via electroporation therapy (ReCET, Endogenex) improved insulin sensitivity, beta-cell function, and other glycemic parameters at 12 and 48 weeks in 51 individuals with T2D. “The findings suggest that duodenal mucosal and submucosal recellularization are key therapeutic targets in type 2 diabetes management,” said Barham Abu Dayyeh, MD, director of Interventional Gastroenterology at Cedar-Sinai Hospital, Los Angeles, in a presentation at Digestive Disease Week (DDW) 2025.

The outpatient technique is based on pulsed electrical fields, or electroporation, which do not use heat. “It’s nonthermal regeneration, not just ablation. It’s regeneration of the duodenum as a treatment target that could potentially modify type 2 diabetes,” Abu Dayyeh told GI & Hepatology News.

Separately at DDW, Abu Dayyeh presented results from an artificial intelligence–based analysis of duodenal biopsies from 111 individuals with T2D and 120 control individuals without diabetes, demonstrating distinct mucosal features associated with metabolic disease, significant inflammation in the deep mucosa and submucosa with increased fibrosis, and gut-barrier dysfunction. The authors termed this set of abnormalities “diabetic duodenopathy.” 

Abu Dayyeh likened the duodenum to a “conductor” of the “dysfunctional orchestra” of metabolic disease that includes T2D. “It’s tasked with integrating signals from the food that we eat and from our microbiome and communicates that metabolic response to downstream organs like the pancreas, liver, and adipose tissue.”

Currently, he said, “We use treatments that work downstream on components of this dysfunctional orchestra. So we work on the violinist and the flute player, but we do not go upstream to say maybe there’s an opportunity to put the orchestra conductor back in synch…We manage blood glycemia by lowering it, rather than looking at upstream disease-modifying targets that could reverse the course so you require less insulin and less medication.” 

Abu Dayyeh envisions the ReCET procedure as an option for people struggling to control T2D with standard medications, or for early use to avoid or delay medications, particularly insulin. But it won’t replace medications. “On the contrary, I see it as enhancing and complementing medications,” he said.

Asked to comment, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, Cleveland, Ohio, told GI & Hepatology News, “Diabetes is a heterogeneous disease complex with numerous pathophysiological derangements. Although diabetic duodenopathy can be seen in some patients with diabetes, that wouldn’t explain the entire story behind diabetes pathogenesis in all people with diabetes. In a subgroup of people with duodenal involvement in their disease process, endoscopic procedures targeting the duodenum may play a role in the future.”

 

Glycemic Parameters Improve Following ReCET Procedure

The new study, called REGENT-1, was a multicenter, open-label, single-arm dose escalation of three levels of energy delivery in patients who had T2D for 10 years or less with A1c levels 7.5%-11% despite the use of one or more noninsulin glucose-lowering medications. Procedural success, defined as treatment of at least 6 cm of duodenum, was achieved in 100% of participants.

From a baseline A1c of 8.6%, there were dose-response drops at weeks 12 and 48 by energy delivery, with significant reductions at week 48 of 1.00 and 1.70 percentage points, respectively, among the 18 who received the middle dose and the 21 given the highest dose. Body weight also dropped in all three groups in a dose-response way, from 1.2% with the lowest to 6.2% with the highest energy delivery.

In mixed-meal tolerance testing, glucose area under the curve, homeostatic model assessment for insulin resistance, sensitivity index, beta-cell function, and disposition index (a measure of beta-cell response to insulin resistance) were all reduced from baseline at 48 weeks after ReCET, reaching statistical significance with the highest energy dose.

There were no device- or procedure-related serious adverse events.

Based on a literature search, Abu Dayyeh found that modern glucagon like peptide-1 receptor agonist medications have a stronger effect than ReCET or Roux-en-Y gastric bypass (RYGB) on beta-cell function (increases by 239% with semaglutide and 314% with tirzepatide vs 50% with ReCET and 74% for RYGB). However, ReCET procedure produced superior results for both insulin sensitivity (+487% for ReCET and +326% for bypass vs 30% and 62%, respectively for semaglutide and tirzepatide) and disposition index (+1032% for ReCET, +667% with tirzepatide, +642% for RYGB, and +367% for semaglutide).

Aminian commented, “The findings of this single arm clinical trial are promising. The next step is to incorporate a blinded control group who undergoes an endoscopy without any therapeutic intervention.”

In fact, such a study is underway. Results of “a multicenter, randomized, double-blind, sham-controlled study for assessing the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (ReCET)” are expected in late 2026.

In the meantime, Amanian said about the current findings, “I’d argue that the observed improvement in diabetes parameters can be related to more intensive medical therapy during follow-up in this single arm study.”

In the trials, the procedure takes 30 minutes to an hour to perform. However, as the technology improves, “the vision of this is to be a 20-minute outpatient procedure eventually,” Abu Dayyeh said.

He envisions that eventually the procedure will become as accessible as colonoscopy is now, and that primary care physicians and endocrinologists would similarly refer patients to a gastroenterologist or surgeon to have it done. “They do the procedure and send your patient back, hopefully with a less complex management strategy, so you could manage them more efficiently without escalating care.” 

Abu Dayyeh is a co-inventor of the ReCET procedure, with the technology licensed by the Mayo Clinic. He is a consultant for and/or reported receiving research support from Boston Scientific, Olympus, Medtronic, Metamodix, BFKW, Apollo Endosurgery, USGI, Endogastric Solutions, Spatz, and Cairn. Aminian had received grants and personal fees from Medtronic and Ethicon. He serves as a consultant for Medtronic, Ethicon, and Eli Lilly.

A version of this article appeared on Medscape.com.

SAN DIEGO – A novel investigational endoscopic procedure targeting the duodenum appears beneficial in improving glycemic parameters in people with type 2 diabetes (T2D).

In a new dose-finding study, the re-cellularization via electroporation therapy (ReCET, Endogenex) improved insulin sensitivity, beta-cell function, and other glycemic parameters at 12 and 48 weeks in 51 individuals with T2D. “The findings suggest that duodenal mucosal and submucosal recellularization are key therapeutic targets in type 2 diabetes management,” said Barham Abu Dayyeh, MD, director of Interventional Gastroenterology at Cedar-Sinai Hospital, Los Angeles, in a presentation at Digestive Disease Week (DDW) 2025.

The outpatient technique is based on pulsed electrical fields, or electroporation, which do not use heat. “It’s nonthermal regeneration, not just ablation. It’s regeneration of the duodenum as a treatment target that could potentially modify type 2 diabetes,” Abu Dayyeh told GI & Hepatology News.

Separately at DDW, Abu Dayyeh presented results from an artificial intelligence–based analysis of duodenal biopsies from 111 individuals with T2D and 120 control individuals without diabetes, demonstrating distinct mucosal features associated with metabolic disease, significant inflammation in the deep mucosa and submucosa with increased fibrosis, and gut-barrier dysfunction. The authors termed this set of abnormalities “diabetic duodenopathy.” 

Abu Dayyeh likened the duodenum to a “conductor” of the “dysfunctional orchestra” of metabolic disease that includes T2D. “It’s tasked with integrating signals from the food that we eat and from our microbiome and communicates that metabolic response to downstream organs like the pancreas, liver, and adipose tissue.”

Currently, he said, “We use treatments that work downstream on components of this dysfunctional orchestra. So we work on the violinist and the flute player, but we do not go upstream to say maybe there’s an opportunity to put the orchestra conductor back in synch…We manage blood glycemia by lowering it, rather than looking at upstream disease-modifying targets that could reverse the course so you require less insulin and less medication.” 

Abu Dayyeh envisions the ReCET procedure as an option for people struggling to control T2D with standard medications, or for early use to avoid or delay medications, particularly insulin. But it won’t replace medications. “On the contrary, I see it as enhancing and complementing medications,” he said.

Asked to comment, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, Cleveland, Ohio, told GI & Hepatology News, “Diabetes is a heterogeneous disease complex with numerous pathophysiological derangements. Although diabetic duodenopathy can be seen in some patients with diabetes, that wouldn’t explain the entire story behind diabetes pathogenesis in all people with diabetes. In a subgroup of people with duodenal involvement in their disease process, endoscopic procedures targeting the duodenum may play a role in the future.”

 

Glycemic Parameters Improve Following ReCET Procedure

The new study, called REGENT-1, was a multicenter, open-label, single-arm dose escalation of three levels of energy delivery in patients who had T2D for 10 years or less with A1c levels 7.5%-11% despite the use of one or more noninsulin glucose-lowering medications. Procedural success, defined as treatment of at least 6 cm of duodenum, was achieved in 100% of participants.

From a baseline A1c of 8.6%, there were dose-response drops at weeks 12 and 48 by energy delivery, with significant reductions at week 48 of 1.00 and 1.70 percentage points, respectively, among the 18 who received the middle dose and the 21 given the highest dose. Body weight also dropped in all three groups in a dose-response way, from 1.2% with the lowest to 6.2% with the highest energy delivery.

In mixed-meal tolerance testing, glucose area under the curve, homeostatic model assessment for insulin resistance, sensitivity index, beta-cell function, and disposition index (a measure of beta-cell response to insulin resistance) were all reduced from baseline at 48 weeks after ReCET, reaching statistical significance with the highest energy dose.

There were no device- or procedure-related serious adverse events.

Based on a literature search, Abu Dayyeh found that modern glucagon like peptide-1 receptor agonist medications have a stronger effect than ReCET or Roux-en-Y gastric bypass (RYGB) on beta-cell function (increases by 239% with semaglutide and 314% with tirzepatide vs 50% with ReCET and 74% for RYGB). However, ReCET procedure produced superior results for both insulin sensitivity (+487% for ReCET and +326% for bypass vs 30% and 62%, respectively for semaglutide and tirzepatide) and disposition index (+1032% for ReCET, +667% with tirzepatide, +642% for RYGB, and +367% for semaglutide).

Aminian commented, “The findings of this single arm clinical trial are promising. The next step is to incorporate a blinded control group who undergoes an endoscopy without any therapeutic intervention.”

In fact, such a study is underway. Results of “a multicenter, randomized, double-blind, sham-controlled study for assessing the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (ReCET)” are expected in late 2026.

In the meantime, Amanian said about the current findings, “I’d argue that the observed improvement in diabetes parameters can be related to more intensive medical therapy during follow-up in this single arm study.”

In the trials, the procedure takes 30 minutes to an hour to perform. However, as the technology improves, “the vision of this is to be a 20-minute outpatient procedure eventually,” Abu Dayyeh said.

He envisions that eventually the procedure will become as accessible as colonoscopy is now, and that primary care physicians and endocrinologists would similarly refer patients to a gastroenterologist or surgeon to have it done. “They do the procedure and send your patient back, hopefully with a less complex management strategy, so you could manage them more efficiently without escalating care.” 

Abu Dayyeh is a co-inventor of the ReCET procedure, with the technology licensed by the Mayo Clinic. He is a consultant for and/or reported receiving research support from Boston Scientific, Olympus, Medtronic, Metamodix, BFKW, Apollo Endosurgery, USGI, Endogastric Solutions, Spatz, and Cairn. Aminian had received grants and personal fees from Medtronic and Ethicon. He serves as a consultant for Medtronic, Ethicon, and Eli Lilly.

A version of this article appeared on Medscape.com.

SAN DIEGO — The session started with a question that many in the audience at Digestive Disease Week (DDW) 2025 seemed to relate to: “How many of you find yourself squeezing workouts into a weekend after a hectic work week?”

Although regular exercise three or more times a week is often viewed as preferable, Shiyi Yu, MD, a resident physician in the Department of Gastroenterology at Guangdong Provincial People’s Hospital in Guangzhou, China, had good news for weekend warriors.

Both patterns reduce digestive disease almost equally.

Her study compared weekend warriors with those she called “active regulars” and sedentary folks to see how activity patterns affect digestive disease risks.

Her bottom line: “Your gut does not care about your schedule.”

The researchers analyzed wrist-based accelerometer data from 89,595 participants in the UK Biobank. To categorize participants as active or inactive, they used the World Health Organization 2020 guidelines for physical activity, which recommend at least 150-300 minutes of moderate-intensity aerobic physical activity or at least 75-150 minutes of vigorous-intensity aerobic physical activity, or an equivalent combination throughout the week. Median age of participants was 63.3 years and 48.8% were men.

They divided participants into three groups:

• About 43% were weekend warriors who met or exceeded 150 minutes of moderate to vigorous physical activity (MVPA), with 50% or more of total MVPA achieved in 1-2 days.
• About 23% were active regulars who met or exceeded 150 minutes a week but spread over more days.
• About 34% were inactive participants who were active less than 150 minutes a week.

The researchers followed the participants for a median of 7.9 years, looking for the incidence of multiple digestive diseases, identified using the International Classification of Diseases, 10th Revision, codes. These included diverticulosis, constipation, metabolic dysfunction–associated steatotic liver disease, cholelithiasis, and gastroesophageal reflux disease. 

Both activity patterns “showed similar risk reduction with no significant difference,” Yu said. At the threshold ≥ 150 minutes, for instance, hazard ratios for any digestive disease were 0.83 for weekend warriors and 0.79 for active regulars, compared with sedentary participants.

The analysis was repeated using a median threshold ≥ 230.4 minutes of MVPA a week, and the researchers found the same results.

As a validation cohort, the researchers used more than 6,000 participants from the National Institutes of Health’s All of Us Research Program with over 6 months of wrist-based accelerometer data.

A recent meta-epidemiology study found that the weekend warrior pattern offers other health benefits, including reducing the risk for cardiovascular disease mortality, mental disorders, and metabolic syndrome.

 

A Pleasant Surprise

The digestive disease study’s findings were “a surprise and a pleasant one,” said Aasma Shaukat, MD, MPH, AGAF, professor of medicine and a gastroenterologist at NYU Grossman School of Medicine, New York City.

“We often think if we’re not able to exercise regularly, then there’s no hope for us,” said Shaukat, who moderated the session. “But this implies that even if we have time only during the weekend to engage in physical activity, it still confers benefits in reducing our risk of any GI health disorder, as well as cardiovascular or other health disorders, compared to people inactive at baseline.”

“It gives us flexibility in terms of how we structure our exercise. Obviously, people should try to get into the habit of doing regular activity; it’s more sustainable. But a good alternative, according to this research, is that packing all of that in over the weekend seems to confer benefit. So all is not lost.”

Will this change her conversation with patients moving forward? Absolutely, Shaukat said. She generally recommends physical activity for at least 30 minutes three times a week. Now Shaukat said she can tell patients: “If that’s not possible, take that time out during the weekend for your health”.

This study was funded by grants from the National Natural Science Foundation of China and its Regional Innovation and Development Joint Foundation. Yu and Shaukat reported no disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — The session started with a question that many in the audience at Digestive Disease Week (DDW) 2025 seemed to relate to: “How many of you find yourself squeezing workouts into a weekend after a hectic work week?”

Although regular exercise three or more times a week is often viewed as preferable, Shiyi Yu, MD, a resident physician in the Department of Gastroenterology at Guangdong Provincial People’s Hospital in Guangzhou, China, had good news for weekend warriors.

Both patterns reduce digestive disease almost equally.

Her study compared weekend warriors with those she called “active regulars” and sedentary folks to see how activity patterns affect digestive disease risks.

Her bottom line: “Your gut does not care about your schedule.”

The researchers analyzed wrist-based accelerometer data from 89,595 participants in the UK Biobank. To categorize participants as active or inactive, they used the World Health Organization 2020 guidelines for physical activity, which recommend at least 150-300 minutes of moderate-intensity aerobic physical activity or at least 75-150 minutes of vigorous-intensity aerobic physical activity, or an equivalent combination throughout the week. Median age of participants was 63.3 years and 48.8% were men.

They divided participants into three groups:

• About 43% were weekend warriors who met or exceeded 150 minutes of moderate to vigorous physical activity (MVPA), with 50% or more of total MVPA achieved in 1-2 days.
• About 23% were active regulars who met or exceeded 150 minutes a week but spread over more days.
• About 34% were inactive participants who were active less than 150 minutes a week.

The researchers followed the participants for a median of 7.9 years, looking for the incidence of multiple digestive diseases, identified using the International Classification of Diseases, 10th Revision, codes. These included diverticulosis, constipation, metabolic dysfunction–associated steatotic liver disease, cholelithiasis, and gastroesophageal reflux disease. 

Both activity patterns “showed similar risk reduction with no significant difference,” Yu said. At the threshold ≥ 150 minutes, for instance, hazard ratios for any digestive disease were 0.83 for weekend warriors and 0.79 for active regulars, compared with sedentary participants.

The analysis was repeated using a median threshold ≥ 230.4 minutes of MVPA a week, and the researchers found the same results.

As a validation cohort, the researchers used more than 6,000 participants from the National Institutes of Health’s All of Us Research Program with over 6 months of wrist-based accelerometer data.

A recent meta-epidemiology study found that the weekend warrior pattern offers other health benefits, including reducing the risk for cardiovascular disease mortality, mental disorders, and metabolic syndrome.

 

A Pleasant Surprise

The digestive disease study’s findings were “a surprise and a pleasant one,” said Aasma Shaukat, MD, MPH, AGAF, professor of medicine and a gastroenterologist at NYU Grossman School of Medicine, New York City.

“We often think if we’re not able to exercise regularly, then there’s no hope for us,” said Shaukat, who moderated the session. “But this implies that even if we have time only during the weekend to engage in physical activity, it still confers benefits in reducing our risk of any GI health disorder, as well as cardiovascular or other health disorders, compared to people inactive at baseline.”

“It gives us flexibility in terms of how we structure our exercise. Obviously, people should try to get into the habit of doing regular activity; it’s more sustainable. But a good alternative, according to this research, is that packing all of that in over the weekend seems to confer benefit. So all is not lost.”

Will this change her conversation with patients moving forward? Absolutely, Shaukat said. She generally recommends physical activity for at least 30 minutes three times a week. Now Shaukat said she can tell patients: “If that’s not possible, take that time out during the weekend for your health”.

This study was funded by grants from the National Natural Science Foundation of China and its Regional Innovation and Development Joint Foundation. Yu and Shaukat reported no disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — The session started with a question that many in the audience at Digestive Disease Week (DDW) 2025 seemed to relate to: “How many of you find yourself squeezing workouts into a weekend after a hectic work week?”

Although regular exercise three or more times a week is often viewed as preferable, Shiyi Yu, MD, a resident physician in the Department of Gastroenterology at Guangdong Provincial People’s Hospital in Guangzhou, China, had good news for weekend warriors.

Both patterns reduce digestive disease almost equally.

Her study compared weekend warriors with those she called “active regulars” and sedentary folks to see how activity patterns affect digestive disease risks.

Her bottom line: “Your gut does not care about your schedule.”

The researchers analyzed wrist-based accelerometer data from 89,595 participants in the UK Biobank. To categorize participants as active or inactive, they used the World Health Organization 2020 guidelines for physical activity, which recommend at least 150-300 minutes of moderate-intensity aerobic physical activity or at least 75-150 minutes of vigorous-intensity aerobic physical activity, or an equivalent combination throughout the week. Median age of participants was 63.3 years and 48.8% were men.

They divided participants into three groups:

• About 43% were weekend warriors who met or exceeded 150 minutes of moderate to vigorous physical activity (MVPA), with 50% or more of total MVPA achieved in 1-2 days.
• About 23% were active regulars who met or exceeded 150 minutes a week but spread over more days.
• About 34% were inactive participants who were active less than 150 minutes a week.

The researchers followed the participants for a median of 7.9 years, looking for the incidence of multiple digestive diseases, identified using the International Classification of Diseases, 10th Revision, codes. These included diverticulosis, constipation, metabolic dysfunction–associated steatotic liver disease, cholelithiasis, and gastroesophageal reflux disease. 

Both activity patterns “showed similar risk reduction with no significant difference,” Yu said. At the threshold ≥ 150 minutes, for instance, hazard ratios for any digestive disease were 0.83 for weekend warriors and 0.79 for active regulars, compared with sedentary participants.

The analysis was repeated using a median threshold ≥ 230.4 minutes of MVPA a week, and the researchers found the same results.

As a validation cohort, the researchers used more than 6,000 participants from the National Institutes of Health’s All of Us Research Program with over 6 months of wrist-based accelerometer data.

A recent meta-epidemiology study found that the weekend warrior pattern offers other health benefits, including reducing the risk for cardiovascular disease mortality, mental disorders, and metabolic syndrome.

 

A Pleasant Surprise

The digestive disease study’s findings were “a surprise and a pleasant one,” said Aasma Shaukat, MD, MPH, AGAF, professor of medicine and a gastroenterologist at NYU Grossman School of Medicine, New York City.

“We often think if we’re not able to exercise regularly, then there’s no hope for us,” said Shaukat, who moderated the session. “But this implies that even if we have time only during the weekend to engage in physical activity, it still confers benefits in reducing our risk of any GI health disorder, as well as cardiovascular or other health disorders, compared to people inactive at baseline.”

“It gives us flexibility in terms of how we structure our exercise. Obviously, people should try to get into the habit of doing regular activity; it’s more sustainable. But a good alternative, according to this research, is that packing all of that in over the weekend seems to confer benefit. So all is not lost.”

Will this change her conversation with patients moving forward? Absolutely, Shaukat said. She generally recommends physical activity for at least 30 minutes three times a week. Now Shaukat said she can tell patients: “If that’s not possible, take that time out during the weekend for your health”.

This study was funded by grants from the National Natural Science Foundation of China and its Regional Innovation and Development Joint Foundation. Yu and Shaukat reported no disclosures.

A version of this article appeared on Medscape.com.

Clinicians can help reduce gastric cancer incidence and mortality in high-risk groups through endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM), according to a new clinical practice update from AGA.

The update supports additional gastric guidance published so far in 2025, including a clinical guideline on the diagnosis and management of gastric premalignant conditions (GPMC) from the American College of Gastroenterology (ACG) and upper GI endoscopy quality indicators from ACG and the American Society for Gastrointestinal Endoscopy (ASGE).

“The synergy of these three publications coming out at the same time helps us to finally establish surveillance of high-risk gastric conditions in practice, as we do in the colon and esophagus,” said Douglas R. Morgan, MD, professor of medicine in gastroenterology and hepatology and director of Global Health programs in gastroenterology at the University of Alabama at Birmingham.

Morgan, who wasn’t involved with the AGA update, served as lead author for the ACG guideline and co-author of the ACG-ASGE quality indicators. He also co-authored the 2024 ACG clinical guideline on treating Helicobacter pylori infection, which has implications for gastric cancer.

“The AGA and ACG updates provide detail, while the QI document is an enforcer with medical, legal, and reimbursement implications,” he said. “We have an alignment of the stars with this overdue move toward concrete surveillance for high-risk lesions in the stomach.”

The clinical practice update was published in Gastroenterology.

 

Gastric Cancer Screening

Gastric cancer remains a leading cause of preventable cancer and mortality in certain US populations, the authors wrote. The top ways to reduce mortality include primary prevention, particularly by eradicating H pylori, and secondary prevention through screening and surveillance.

High-risk groups in the United States should be considered for gastric cancer screening, including first-generation immigrants from high-incidence regions and potentially other non-White racial and ethnic groups, those with a family history of gastric cancer in a first-degree relative, and those with certain hereditary GI polyposis or hereditary cancer syndromes.

Endoscopy remains the best test for screening or surveillance of high-risk groups, the authors wrote, since it allows for direct visualization to endoscopically stage the mucosa, identify any concerning areas of neoplasia, and enable biopsies. Both endoscopic and histologic staging are key for risk stratification and surveillance decisions.

In particular, clinicians should use a high-definition white light endoscopy system with image enhancement, gastric mucosal cleansing, and insufflation to see the mucosa. As part of this, clinicians should allow for adequate visual inspection time, photodocumentation, and systematic biopsy protocol for mucosal staging, where appropriate.

As part of this, clinicians should consider H pylori eradication as an essential adjunct to endoscopic screening, the authors wrote. Opportunistic screening for H pylori should be considered in high-risk groups, and familial-based testing should be considered among adult household members of patients who test positive for H pylori.

 

Endoscopic Biopsy and Diagnosis

In patients with suspected gastric atrophy — with or without GIM — gastric biopsies should be obtained with a systematic approach, the authors wrote. Clinicians should take a minimum of five biopsies, sampling from the antrum/incisura and corpus.

Endoscopists should work with their pathologists on consistent documentation of histologic risk-stratification parameters when atrophic gastritis is diagnosed, the authors wrote. To inform clinical decision-making, this should include documentation of the presence or absence of H pylori infection, severity of atrophy or metaplasia, and histologic subtyping of GIM.

Although GIM and dysplasia are endoscopically detectable, these findings often go undiagnosed when endoscopists aren’t familiar with the characteristic visual features, the authors wrote. More training is needed, especially in the US, and although artificial intelligence tools appear promising for detecting early gastric neoplasia, data remain too preliminary to recommend routine use, the authors added.

Since indefinite and low-grade dysplasia can be difficult to identify by endoscopy and accurately diagnosis on histopathology, all dysplasia should be confirmed by an experienced gastrointestinal pathologist, the authors wrote. Clinicians should refer patients with visible or nonvisible dysplasia to an endoscopist or center with expertise in gastric neoplasia.

 

Endoscopic Management and Surveillance

If an index screening endoscopy doesn’t identify atrophy, GIM, or neoplasia, ongoing screening should be based on a patient’s risk factors and preferences. If the patient has a family history or multiple risk factors, ongoing screening should be considered. However, the optimal screening intervals in these scenarios aren’t well-defined.

Patients with confirmed gastric atrophy should undergo risk stratification, the authors wrote. Those with severe atrophic gastritis or multifocal/incomplete GIM would likely benefit from endoscopic surveillance, particularly if they have other risk factors such as family history. Surveillance should be considered every 3 years, though shorter intervals may be advisable for those with multiple risk factors such as severe GIM.

Patients with high-grade dysplasia or early gastric cancer should undergo endoscopic submucosal dissection (ESD), with the goal of en bloc, R0 resection to enable accurate pathologic staging and the intent to cure. Eradicating active H pylori infection is essential — but shouldn’t delay endoscopic intervention, the authors wrote.

In addition, patients with a history of successfully resected gastric dysplasia or cancer should undergo endoscopic surveillance. Although post-ESD surveillance intervals have been suggested in other recent AGA clinical practice updates, additional data are needed, particularly for US recommendations, the authors wrote.

Although type 1 gastric carcinoids in patients with atrophic gastritis are typically indolent, especially if less than 1 cm, endoscopists may consider resecting them and should resect lesions between 1and 2 cm. Patients with lesions over 2 cm should undergo cross-sectional imaging and be referred for surgical resection, given the risk for metastasis.

 

Patient-Centered Approach

The guideline authors suggested thinking about screening and surveillance on a patient-level basis. For instance, only those who are fit for endoscopic or potentially surgical treatment should be screened for gastric cancer and continued surveillance of GPMC, they wrote. If a person is no longer fit for endoscopic or surgical treatment, whether due to life expectancy or other comorbidities, then screening should be stopped.

In addition, to achieve health equity, clinicians should take a personalized approach to assess a patient’s risk for gastric cancer and determine whether to pursue screening and surveillance, the authors wrote. Modifiable risk factors — such as tobacco use, high-salt and processed food diets, and lack of health care — should also be addressed, since most of these risk factors disproportionately affect high-risk patients and represent healthcare disparities, they added.

“This update provides clinicians with a framework for understanding the natural history and epidemiology of gastric polyps, as well as guidance on best practices for the endoscopic detection and classification of gastric polyps, best practices for the endoscopic resection of gastric polyps, and best practices for endoscopic surveillance following resection,” said Hashem El-Serag, MD, professor and chair of medicine at the Baylor College of Medicine and director of the Texas Medical Center Digestive Diseases Center in Houston.

El-Serag, who wasn’t involved with the clinical practice update, has researched and published on consensus around the diagnosis and management of GIM.

“Stomach polyps are commonly found during routine endoscopic procedures. They are mostly asymptomatic and incidental, and therefore, clinicians may not be prepared ahead of time on how to deal with them,” he said. “The appropriate management requires proper identification and sampling of the polyp features and the uninvolved gastric mucosa, as well as a clear understanding of the risk factors and prognosis. Recent changes in the epidemiology and endoscopic management of gastric polyps makes this update timely and important.”

The update received no particular funding. The authors disclosed receiving grant support, having consultant relationships with, and serving in advisory roles for numerous pharmaceutical, biomedical, and biotechnology firms. Morgan and El-Serag reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

Clinicians can help reduce gastric cancer incidence and mortality in high-risk groups through endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM), according to a new clinical practice update from AGA.

The update supports additional gastric guidance published so far in 2025, including a clinical guideline on the diagnosis and management of gastric premalignant conditions (GPMC) from the American College of Gastroenterology (ACG) and upper GI endoscopy quality indicators from ACG and the American Society for Gastrointestinal Endoscopy (ASGE).

“The synergy of these three publications coming out at the same time helps us to finally establish surveillance of high-risk gastric conditions in practice, as we do in the colon and esophagus,” said Douglas R. Morgan, MD, professor of medicine in gastroenterology and hepatology and director of Global Health programs in gastroenterology at the University of Alabama at Birmingham.

Morgan, who wasn’t involved with the AGA update, served as lead author for the ACG guideline and co-author of the ACG-ASGE quality indicators. He also co-authored the 2024 ACG clinical guideline on treating Helicobacter pylori infection, which has implications for gastric cancer.

“The AGA and ACG updates provide detail, while the QI document is an enforcer with medical, legal, and reimbursement implications,” he said. “We have an alignment of the stars with this overdue move toward concrete surveillance for high-risk lesions in the stomach.”

The clinical practice update was published in Gastroenterology.

 

Gastric Cancer Screening

Gastric cancer remains a leading cause of preventable cancer and mortality in certain US populations, the authors wrote. The top ways to reduce mortality include primary prevention, particularly by eradicating H pylori, and secondary prevention through screening and surveillance.

High-risk groups in the United States should be considered for gastric cancer screening, including first-generation immigrants from high-incidence regions and potentially other non-White racial and ethnic groups, those with a family history of gastric cancer in a first-degree relative, and those with certain hereditary GI polyposis or hereditary cancer syndromes.

Endoscopy remains the best test for screening or surveillance of high-risk groups, the authors wrote, since it allows for direct visualization to endoscopically stage the mucosa, identify any concerning areas of neoplasia, and enable biopsies. Both endoscopic and histologic staging are key for risk stratification and surveillance decisions.

In particular, clinicians should use a high-definition white light endoscopy system with image enhancement, gastric mucosal cleansing, and insufflation to see the mucosa. As part of this, clinicians should allow for adequate visual inspection time, photodocumentation, and systematic biopsy protocol for mucosal staging, where appropriate.

As part of this, clinicians should consider H pylori eradication as an essential adjunct to endoscopic screening, the authors wrote. Opportunistic screening for H pylori should be considered in high-risk groups, and familial-based testing should be considered among adult household members of patients who test positive for H pylori.

 

Endoscopic Biopsy and Diagnosis

In patients with suspected gastric atrophy — with or without GIM — gastric biopsies should be obtained with a systematic approach, the authors wrote. Clinicians should take a minimum of five biopsies, sampling from the antrum/incisura and corpus.

Endoscopists should work with their pathologists on consistent documentation of histologic risk-stratification parameters when atrophic gastritis is diagnosed, the authors wrote. To inform clinical decision-making, this should include documentation of the presence or absence of H pylori infection, severity of atrophy or metaplasia, and histologic subtyping of GIM.

Although GIM and dysplasia are endoscopically detectable, these findings often go undiagnosed when endoscopists aren’t familiar with the characteristic visual features, the authors wrote. More training is needed, especially in the US, and although artificial intelligence tools appear promising for detecting early gastric neoplasia, data remain too preliminary to recommend routine use, the authors added.

Since indefinite and low-grade dysplasia can be difficult to identify by endoscopy and accurately diagnosis on histopathology, all dysplasia should be confirmed by an experienced gastrointestinal pathologist, the authors wrote. Clinicians should refer patients with visible or nonvisible dysplasia to an endoscopist or center with expertise in gastric neoplasia.

 

Endoscopic Management and Surveillance

If an index screening endoscopy doesn’t identify atrophy, GIM, or neoplasia, ongoing screening should be based on a patient’s risk factors and preferences. If the patient has a family history or multiple risk factors, ongoing screening should be considered. However, the optimal screening intervals in these scenarios aren’t well-defined.

Patients with confirmed gastric atrophy should undergo risk stratification, the authors wrote. Those with severe atrophic gastritis or multifocal/incomplete GIM would likely benefit from endoscopic surveillance, particularly if they have other risk factors such as family history. Surveillance should be considered every 3 years, though shorter intervals may be advisable for those with multiple risk factors such as severe GIM.

Patients with high-grade dysplasia or early gastric cancer should undergo endoscopic submucosal dissection (ESD), with the goal of en bloc, R0 resection to enable accurate pathologic staging and the intent to cure. Eradicating active H pylori infection is essential — but shouldn’t delay endoscopic intervention, the authors wrote.

In addition, patients with a history of successfully resected gastric dysplasia or cancer should undergo endoscopic surveillance. Although post-ESD surveillance intervals have been suggested in other recent AGA clinical practice updates, additional data are needed, particularly for US recommendations, the authors wrote.

Although type 1 gastric carcinoids in patients with atrophic gastritis are typically indolent, especially if less than 1 cm, endoscopists may consider resecting them and should resect lesions between 1and 2 cm. Patients with lesions over 2 cm should undergo cross-sectional imaging and be referred for surgical resection, given the risk for metastasis.

 

Patient-Centered Approach

The guideline authors suggested thinking about screening and surveillance on a patient-level basis. For instance, only those who are fit for endoscopic or potentially surgical treatment should be screened for gastric cancer and continued surveillance of GPMC, they wrote. If a person is no longer fit for endoscopic or surgical treatment, whether due to life expectancy or other comorbidities, then screening should be stopped.

In addition, to achieve health equity, clinicians should take a personalized approach to assess a patient’s risk for gastric cancer and determine whether to pursue screening and surveillance, the authors wrote. Modifiable risk factors — such as tobacco use, high-salt and processed food diets, and lack of health care — should also be addressed, since most of these risk factors disproportionately affect high-risk patients and represent healthcare disparities, they added.

“This update provides clinicians with a framework for understanding the natural history and epidemiology of gastric polyps, as well as guidance on best practices for the endoscopic detection and classification of gastric polyps, best practices for the endoscopic resection of gastric polyps, and best practices for endoscopic surveillance following resection,” said Hashem El-Serag, MD, professor and chair of medicine at the Baylor College of Medicine and director of the Texas Medical Center Digestive Diseases Center in Houston.

El-Serag, who wasn’t involved with the clinical practice update, has researched and published on consensus around the diagnosis and management of GIM.

“Stomach polyps are commonly found during routine endoscopic procedures. They are mostly asymptomatic and incidental, and therefore, clinicians may not be prepared ahead of time on how to deal with them,” he said. “The appropriate management requires proper identification and sampling of the polyp features and the uninvolved gastric mucosa, as well as a clear understanding of the risk factors and prognosis. Recent changes in the epidemiology and endoscopic management of gastric polyps makes this update timely and important.”

The update received no particular funding. The authors disclosed receiving grant support, having consultant relationships with, and serving in advisory roles for numerous pharmaceutical, biomedical, and biotechnology firms. Morgan and El-Serag reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

Clinicians can help reduce gastric cancer incidence and mortality in high-risk groups through endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM), according to a new clinical practice update from AGA.

The update supports additional gastric guidance published so far in 2025, including a clinical guideline on the diagnosis and management of gastric premalignant conditions (GPMC) from the American College of Gastroenterology (ACG) and upper GI endoscopy quality indicators from ACG and the American Society for Gastrointestinal Endoscopy (ASGE).

“The synergy of these three publications coming out at the same time helps us to finally establish surveillance of high-risk gastric conditions in practice, as we do in the colon and esophagus,” said Douglas R. Morgan, MD, professor of medicine in gastroenterology and hepatology and director of Global Health programs in gastroenterology at the University of Alabama at Birmingham.

Morgan, who wasn’t involved with the AGA update, served as lead author for the ACG guideline and co-author of the ACG-ASGE quality indicators. He also co-authored the 2024 ACG clinical guideline on treating Helicobacter pylori infection, which has implications for gastric cancer.

“The AGA and ACG updates provide detail, while the QI document is an enforcer with medical, legal, and reimbursement implications,” he said. “We have an alignment of the stars with this overdue move toward concrete surveillance for high-risk lesions in the stomach.”

The clinical practice update was published in Gastroenterology.

 

Gastric Cancer Screening

Gastric cancer remains a leading cause of preventable cancer and mortality in certain US populations, the authors wrote. The top ways to reduce mortality include primary prevention, particularly by eradicating H pylori, and secondary prevention through screening and surveillance.

High-risk groups in the United States should be considered for gastric cancer screening, including first-generation immigrants from high-incidence regions and potentially other non-White racial and ethnic groups, those with a family history of gastric cancer in a first-degree relative, and those with certain hereditary GI polyposis or hereditary cancer syndromes.

Endoscopy remains the best test for screening or surveillance of high-risk groups, the authors wrote, since it allows for direct visualization to endoscopically stage the mucosa, identify any concerning areas of neoplasia, and enable biopsies. Both endoscopic and histologic staging are key for risk stratification and surveillance decisions.

In particular, clinicians should use a high-definition white light endoscopy system with image enhancement, gastric mucosal cleansing, and insufflation to see the mucosa. As part of this, clinicians should allow for adequate visual inspection time, photodocumentation, and systematic biopsy protocol for mucosal staging, where appropriate.

As part of this, clinicians should consider H pylori eradication as an essential adjunct to endoscopic screening, the authors wrote. Opportunistic screening for H pylori should be considered in high-risk groups, and familial-based testing should be considered among adult household members of patients who test positive for H pylori.

 

Endoscopic Biopsy and Diagnosis

In patients with suspected gastric atrophy — with or without GIM — gastric biopsies should be obtained with a systematic approach, the authors wrote. Clinicians should take a minimum of five biopsies, sampling from the antrum/incisura and corpus.

Endoscopists should work with their pathologists on consistent documentation of histologic risk-stratification parameters when atrophic gastritis is diagnosed, the authors wrote. To inform clinical decision-making, this should include documentation of the presence or absence of H pylori infection, severity of atrophy or metaplasia, and histologic subtyping of GIM.

Although GIM and dysplasia are endoscopically detectable, these findings often go undiagnosed when endoscopists aren’t familiar with the characteristic visual features, the authors wrote. More training is needed, especially in the US, and although artificial intelligence tools appear promising for detecting early gastric neoplasia, data remain too preliminary to recommend routine use, the authors added.

Since indefinite and low-grade dysplasia can be difficult to identify by endoscopy and accurately diagnosis on histopathology, all dysplasia should be confirmed by an experienced gastrointestinal pathologist, the authors wrote. Clinicians should refer patients with visible or nonvisible dysplasia to an endoscopist or center with expertise in gastric neoplasia.

 

Endoscopic Management and Surveillance

If an index screening endoscopy doesn’t identify atrophy, GIM, or neoplasia, ongoing screening should be based on a patient’s risk factors and preferences. If the patient has a family history or multiple risk factors, ongoing screening should be considered. However, the optimal screening intervals in these scenarios aren’t well-defined.

Patients with confirmed gastric atrophy should undergo risk stratification, the authors wrote. Those with severe atrophic gastritis or multifocal/incomplete GIM would likely benefit from endoscopic surveillance, particularly if they have other risk factors such as family history. Surveillance should be considered every 3 years, though shorter intervals may be advisable for those with multiple risk factors such as severe GIM.

Patients with high-grade dysplasia or early gastric cancer should undergo endoscopic submucosal dissection (ESD), with the goal of en bloc, R0 resection to enable accurate pathologic staging and the intent to cure. Eradicating active H pylori infection is essential — but shouldn’t delay endoscopic intervention, the authors wrote.

In addition, patients with a history of successfully resected gastric dysplasia or cancer should undergo endoscopic surveillance. Although post-ESD surveillance intervals have been suggested in other recent AGA clinical practice updates, additional data are needed, particularly for US recommendations, the authors wrote.

Although type 1 gastric carcinoids in patients with atrophic gastritis are typically indolent, especially if less than 1 cm, endoscopists may consider resecting them and should resect lesions between 1and 2 cm. Patients with lesions over 2 cm should undergo cross-sectional imaging and be referred for surgical resection, given the risk for metastasis.

 

Patient-Centered Approach

The guideline authors suggested thinking about screening and surveillance on a patient-level basis. For instance, only those who are fit for endoscopic or potentially surgical treatment should be screened for gastric cancer and continued surveillance of GPMC, they wrote. If a person is no longer fit for endoscopic or surgical treatment, whether due to life expectancy or other comorbidities, then screening should be stopped.

In addition, to achieve health equity, clinicians should take a personalized approach to assess a patient’s risk for gastric cancer and determine whether to pursue screening and surveillance, the authors wrote. Modifiable risk factors — such as tobacco use, high-salt and processed food diets, and lack of health care — should also be addressed, since most of these risk factors disproportionately affect high-risk patients and represent healthcare disparities, they added.

“This update provides clinicians with a framework for understanding the natural history and epidemiology of gastric polyps, as well as guidance on best practices for the endoscopic detection and classification of gastric polyps, best practices for the endoscopic resection of gastric polyps, and best practices for endoscopic surveillance following resection,” said Hashem El-Serag, MD, professor and chair of medicine at the Baylor College of Medicine and director of the Texas Medical Center Digestive Diseases Center in Houston.

El-Serag, who wasn’t involved with the clinical practice update, has researched and published on consensus around the diagnosis and management of GIM.

“Stomach polyps are commonly found during routine endoscopic procedures. They are mostly asymptomatic and incidental, and therefore, clinicians may not be prepared ahead of time on how to deal with them,” he said. “The appropriate management requires proper identification and sampling of the polyp features and the uninvolved gastric mucosa, as well as a clear understanding of the risk factors and prognosis. Recent changes in the epidemiology and endoscopic management of gastric polyps makes this update timely and important.”

The update received no particular funding. The authors disclosed receiving grant support, having consultant relationships with, and serving in advisory roles for numerous pharmaceutical, biomedical, and biotechnology firms. Morgan and El-Serag reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

Dear colleagues,

Many of us diagnose and treat patients with Barrett’s esophagus, estimated to affect up to 5.6% of the US adult population. There has been an expanding array of tools to help diagnose and effectively treat Barrett’s esophagus with dysplasia and malignancy. In particular, endoscopic submucosal dissection (ESD) has emerged as an important method for treating early cancer in the gastrointestinal tract.

But how do we incorporate ESD into our algorithm for management, especially with the popularity and effectiveness of endoscopic mucosal resection (EMR)? In this issue of Perspectives we aim to provide context for the use of ESD, as compared with EMR. Dr. Silvio de Melo discusses his preferred EMR technique and its many advantages in the management of BE, including for residual or refractory areas. In contrast, Dr. Mohamed Othman reviews the power of ESD and when we should consider this approach over EMR. We hope these discussions will facilitate your care for patients with Barrett’s esophagus.

We also welcome your thoughts on this topic — join the conversation on X at @AGA_GIHN. 

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.

Endoscopic Mucosal Resection: The ‘Workhorse’ for Patient Care

BY SILVIO W. DE MELO JR, MD, AGAF

Barrett’s esophagus (BE) remains an important clinical problem, being one of the modifiable risk factors for esophageal adenocarcinoma. The care for BE is complex and requires several steps to correctly formulate a therapeutic plan. It starts with a proper endoscopic examination. It is recommended to spend at least 1 minute inspecting and evaluating every centimeter of the salmon-colored epithelium, looking for change in vascular pattern, erosions/ulcers, nodules, and/or masses. After the inspection, random biopsies every 1-2 cm plus targeted biopsies will guide you. It is still controversial if the addition of other sampling strategies, such as brushings or confocal endomicroscopy, is needed.

The introduction of radiofrequency ablation (RFA) was paramount in popularizing the treatment options for BE and sunsetting the previous dominant modality, photodynamic therapy (PDT). RFA proved to have a superior clinical efficacy in replacing the intestinal metaplasia/BE with neosquamous epithelium while boosting a much better safety profile, compared with PDT. However, RFA is most efficacious for “flat BE” and it is not an effective, nor recommended, method to treat nodular BE or early cancer, such as carcinoma in situ or nodular high-grade dysplasia. Endoscopic mucosal resection (EMR) is utilized to overcome those limitations.

There are several techniques utilized for EMR:

• The lift and snare technique.
• The snare-in-cap technique.
• The Band-snare technique.

The free-hand submucosal lift and snare is not frequently used in the esophagus. It is difficult to maintain visualization while being confident that one has the whole lesion inside the snare and that the distal (anal side) part of the lesion is free of any unwanted tissue (to minimize complications such as perforations or unwelcomed gastric resections). It is difficult after the first resection to lift an adjacent area, as the fluid easily leaks from the first resected spot, thus removing larger lesions in piece-meal fashion is challenging. This technique can be used in small (in my personal experience, less than 5 mm) lesions, but, given that there are better and safer alternatives, I almost never use this technique for my esophageal EMR cases. I prefer to use the band-snare technique even for lesions under 5 mm.

The snare-in-cap technique has been utilized in the esophagus. In this technique, a cap is attached to the distal end of the scope and the size of the resection is determined by the size of the cap, usually under 1.5 cm. Because of the risk of perforation without previous lifting, it is required that the lesion is lifted with a submucosal fluid, saline or any Food and Drug Administration–approved EMR solution. The lesion is then suctioned inside the cap where the snare had been previously opened inside the cap, the snare is closed, and the tissue is resected. The same limitations regarding the inability to remove larger lesions (greater than 1.5 cm) because of the challenge in lifting the adjacent area applies here. However, the perforation risk for this technique is higher than the traditional lift and the band and snare techniques. Thus, this technique has fallen out of favor for most endoscopists.

The third technique (band-snare EMR) is the one that most endoscopists use for endoscopic mucosal resection. It is a small variation of the already time-tested and very familiar procedure of esophageal variceal band ligation (EVL). There are multiple commercially available kits for esophageal EMR. The kit contains the chamber with the bands and a proprietary hexagonal snare used to resect the specimen.

The advantages of this technique are:

• It is widely commercially available.
• It builds on a familiar procedure, EVL, therefore the learning curve is short.
• The set-up is quick and the procedure can be completed safely and effectively.
• There is no need for injecting the submucosal with a lifting solution.
• Despite the band having a size limitation of 1 cm, one can remove larger lesions by repeating the band and resect process, using the rosette technique.

Band-snare EMR also has limitations:

• There are only six bands on each chamber. Depending on the size of the lesion, one may need to use multiple kits.
• It is not suitable for en bloc resection of lesions greater than 1 cm.

My experience with band EMR is that we can complete the procedure in under 1 hour. The dreaded complication of perforation occurs in under 1% of cases, most bleeding episodes can easily be controlled endoscopically, and the risk of post-EMR stricture is minimal. Therefore, band EMR is the most used technique for esophageal endoscopic resections.

Esophageal EMR is also effective for other indications in BE therapy, such as residual and recurrent BE. Band-snare EMR can be used for an en bloc resection or rosette technique for the areas resistant to ablation therapies with great success and safety.

From a financial standpoint, comparing EMR with endoscopic submucosal dissection (ESD), EMR is the superior strategy given that EMR is widely available, has a much shorter learning curve, has a greater safety profile, is applicable to a wider variety of indications, and has a more favorable return on investment. EMR should be the workhorse for the care of patients with BE, reserving ESD for specific indications.

In summary, there is no “one-size-fits-all” endoscopic therapy in the care of BE. Most Barrett’s patients can be successfully treated with a combination of ablation plus EMR, reserving ESD for select cases.

Dr. de Melo is section chief of gastroenterology at the Orlando VA Healthcare System, Orlando, Florida. He declares no conflicts of interest.

ESD Over EMR for Resecting Esophageal Lesions

BY MOHAMED O. OTHMAN, MD, AGAF

Although endoscopic submucosal dissection (ESD) is the preferred endoscopic resection method in the East, the adoption of this technique in the West, particularly in the United States, has faced many hurdles. Many endoscopists who routinely perform piecemeal endoscopic mucosal resection (EMR) question the utility of ESD, arguing that EMR is just as effective. While this may hold true in certain situations, the global trend in the endoscopic treatment of early esophageal squamous cell carcinoma, nodular Barrett’s esophagus (BE), and early esophageal adenocarcinoma (EAC) has clearly shifted toward ESD. In this perspective, I will summarize why ESD is preferred over EMR for these indications and explore why ESD has yet to gain widespread adoption in the United States.

The superiority of ESD over EMR has been well established in multiple publications from both Eastern and Western literature. Mejia-Perez et al, in a multicenter cohort study from eight centers in North America, compared outcomes of ESD vs EMR for BE with high-grade dysplasia (HGD) or T1a adenocarcinoma in 243 patients. ESD achieved significantly higher en bloc resection rates (89% vs 43%) and R0 resection rates (73% vs 56%), compared with EMR, along with a substantially lower recurrence/residual disease rate on follow-up (3.5% in the ESD group vs 31.4% in EMR group). Additionally, more patients required repeat endoscopic resection after EMR to treat residual or recurrent disease (EMR, 24.2% vs ESD, 3.5%; P < .001).

Han et al conducted a meta-analysis of 22 studies comparing ESD and EMR for early esophageal neoplasia, including both squamous cell carcinoma (SCC) and BE-associated lesions. ESD was associated with significantly higher curative resection rates than EMR (OR, 9.74; 95% CI, 4.83-19.62; P < .0001). Of note, lesion size was a critical factor in determining the advantage of ESD. For lesions ≤ 10 mm, curative resection rates were comparable between ESD and EMR. However, for lesions > 10 mm, ESD achieved significantly higher curative resection rates. This size-based recommendation has been adopted by the American Society of Gastrointestinal Endoscopy (ASGE) in their recent guidelines on ESD indications for esophageal lesions. ASGE guidelines favors ESD over EMR for SCC lesions > 15 mm and for nodular BE with dysplasia or early EAC > 20 mm.

ESD is particularly beneficial in patients who develop early adenocarcinoma after RFA or EMR. Mesureur et al evaluated the efficacy of salvage ESD for Barrett’s recurrence or residual BE following RFA. In their multicenter retrospective study of 56 patients, salvage ESD achieved an en bloc resection rate of 89.3%, despite significant fibrosis, with an R0 resection rate of 66%. At a median follow-up of 14 months, most patients remained in endoscopic remission without the need for esophagectomy.

Combining ESD with RFA has also been shown to accelerate the eradication of BE with dysplasia while reducing the number of required sessions. Our group demonstrated the high efficacy of ESD followed by RFA in 18 patients, most of whom had long-segment BE with HGD or EAC. On average, patients required only one to two RFA sessions after ESD to achieve complete eradication of intestinal metaplasia (CE-IM). Over a median follow-up of 42.5 months (IQR, 28-59.25), complete eradication of early esophageal cancer was achieved in 13 patients (100%), eradication of dysplasia in 15 patients (100%), and CE-IM in 14 patients (77.8%).

Despite the overwhelming evidence supporting ESD and the strong endorsement from professional societies, adoption in the West continues to lag. Several factors contribute to this gap. First, ESD has a steep learning curve. Our data showed that, on average, an untutored practitioner achieved competency after 150-250 procedures, a finding corroborated by other US groups.

Second, there is no specific CPT code for ESD in the United States. Physicians are forced to bill the procedure as EMR or use an unlisted code, resulting in reimbursement that does not reflect the time and complexity of the procedure. Our group showed that physician reimbursement for ESD is highly variable, ranging from $50 to $800 per case, depending on insurance type.

Third, the increasing emphasis on productivity and RVU generation in academic settings has hindered the growth of ESD training in many institutions. Still, the outlook for ESD in the United States remains encouraging. Multiple industry-sponsored training courses are held annually, and professional societies are investing heavily in expanding access to structured education in ESD. Industry is also innovating devices that improve procedural efficiency and safety. Adopting novel approaches, such as traction-assisted ESD, has made the technique more appealing to endoscopists concerned about long procedure times. For example, our group proposed a standardized esophageal ESD technique that incorporates specimen self-retraction. This method improves both safety and speed and has helped address several procedural challenges. We’ve demonstrated that consistency in technique can substantially expedite esophageal ESD.

Fast forward 5 years: We anticipate a dedicated CPT code for ESD, broader access to advanced resection tools, and an expanding number of fellowships offering structured ESD training. These developments are poised to eliminate many of the current barriers. In summary, with robust data supporting the efficacy of ESD in early esophageal cancer, the focus in the United States should shift toward mastering and integrating the technique, rather than dismissing it in favor of piecemeal EMR.

Dr. Othman is chief of the gastroenterology and hepatology section at Baylor College of Medicine and Medicine Subspecialities Service Line Chief at Baylor St Luke’s Medical Center, both in Houston. He declares no conflicts of interest.

Dear colleagues,

Many of us diagnose and treat patients with Barrett’s esophagus, estimated to affect up to 5.6% of the US adult population. There has been an expanding array of tools to help diagnose and effectively treat Barrett’s esophagus with dysplasia and malignancy. In particular, endoscopic submucosal dissection (ESD) has emerged as an important method for treating early cancer in the gastrointestinal tract.

But how do we incorporate ESD into our algorithm for management, especially with the popularity and effectiveness of endoscopic mucosal resection (EMR)? In this issue of Perspectives we aim to provide context for the use of ESD, as compared with EMR. Dr. Silvio de Melo discusses his preferred EMR technique and its many advantages in the management of BE, including for residual or refractory areas. In contrast, Dr. Mohamed Othman reviews the power of ESD and when we should consider this approach over EMR. We hope these discussions will facilitate your care for patients with Barrett’s esophagus.

We also welcome your thoughts on this topic — join the conversation on X at @AGA_GIHN. 

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.

Endoscopic Mucosal Resection: The ‘Workhorse’ for Patient Care

BY SILVIO W. DE MELO JR, MD, AGAF

Barrett’s esophagus (BE) remains an important clinical problem, being one of the modifiable risk factors for esophageal adenocarcinoma. The care for BE is complex and requires several steps to correctly formulate a therapeutic plan. It starts with a proper endoscopic examination. It is recommended to spend at least 1 minute inspecting and evaluating every centimeter of the salmon-colored epithelium, looking for change in vascular pattern, erosions/ulcers, nodules, and/or masses. After the inspection, random biopsies every 1-2 cm plus targeted biopsies will guide you. It is still controversial if the addition of other sampling strategies, such as brushings or confocal endomicroscopy, is needed.

The introduction of radiofrequency ablation (RFA) was paramount in popularizing the treatment options for BE and sunsetting the previous dominant modality, photodynamic therapy (PDT). RFA proved to have a superior clinical efficacy in replacing the intestinal metaplasia/BE with neosquamous epithelium while boosting a much better safety profile, compared with PDT. However, RFA is most efficacious for “flat BE” and it is not an effective, nor recommended, method to treat nodular BE or early cancer, such as carcinoma in situ or nodular high-grade dysplasia. Endoscopic mucosal resection (EMR) is utilized to overcome those limitations.

There are several techniques utilized for EMR:

• The lift and snare technique.
• The snare-in-cap technique.
• The Band-snare technique.

The free-hand submucosal lift and snare is not frequently used in the esophagus. It is difficult to maintain visualization while being confident that one has the whole lesion inside the snare and that the distal (anal side) part of the lesion is free of any unwanted tissue (to minimize complications such as perforations or unwelcomed gastric resections). It is difficult after the first resection to lift an adjacent area, as the fluid easily leaks from the first resected spot, thus removing larger lesions in piece-meal fashion is challenging. This technique can be used in small (in my personal experience, less than 5 mm) lesions, but, given that there are better and safer alternatives, I almost never use this technique for my esophageal EMR cases. I prefer to use the band-snare technique even for lesions under 5 mm.

The snare-in-cap technique has been utilized in the esophagus. In this technique, a cap is attached to the distal end of the scope and the size of the resection is determined by the size of the cap, usually under 1.5 cm. Because of the risk of perforation without previous lifting, it is required that the lesion is lifted with a submucosal fluid, saline or any Food and Drug Administration–approved EMR solution. The lesion is then suctioned inside the cap where the snare had been previously opened inside the cap, the snare is closed, and the tissue is resected. The same limitations regarding the inability to remove larger lesions (greater than 1.5 cm) because of the challenge in lifting the adjacent area applies here. However, the perforation risk for this technique is higher than the traditional lift and the band and snare techniques. Thus, this technique has fallen out of favor for most endoscopists.

The third technique (band-snare EMR) is the one that most endoscopists use for endoscopic mucosal resection. It is a small variation of the already time-tested and very familiar procedure of esophageal variceal band ligation (EVL). There are multiple commercially available kits for esophageal EMR. The kit contains the chamber with the bands and a proprietary hexagonal snare used to resect the specimen.

The advantages of this technique are:

• It is widely commercially available.
• It builds on a familiar procedure, EVL, therefore the learning curve is short.
• The set-up is quick and the procedure can be completed safely and effectively.
• There is no need for injecting the submucosal with a lifting solution.
• Despite the band having a size limitation of 1 cm, one can remove larger lesions by repeating the band and resect process, using the rosette technique.

Band-snare EMR also has limitations:

• There are only six bands on each chamber. Depending on the size of the lesion, one may need to use multiple kits.
• It is not suitable for en bloc resection of lesions greater than 1 cm.

My experience with band EMR is that we can complete the procedure in under 1 hour. The dreaded complication of perforation occurs in under 1% of cases, most bleeding episodes can easily be controlled endoscopically, and the risk of post-EMR stricture is minimal. Therefore, band EMR is the most used technique for esophageal endoscopic resections.

Esophageal EMR is also effective for other indications in BE therapy, such as residual and recurrent BE. Band-snare EMR can be used for an en bloc resection or rosette technique for the areas resistant to ablation therapies with great success and safety.

From a financial standpoint, comparing EMR with endoscopic submucosal dissection (ESD), EMR is the superior strategy given that EMR is widely available, has a much shorter learning curve, has a greater safety profile, is applicable to a wider variety of indications, and has a more favorable return on investment. EMR should be the workhorse for the care of patients with BE, reserving ESD for specific indications.

In summary, there is no “one-size-fits-all” endoscopic therapy in the care of BE. Most Barrett’s patients can be successfully treated with a combination of ablation plus EMR, reserving ESD for select cases.

Dr. de Melo is section chief of gastroenterology at the Orlando VA Healthcare System, Orlando, Florida. He declares no conflicts of interest.

ESD Over EMR for Resecting Esophageal Lesions

BY MOHAMED O. OTHMAN, MD, AGAF

Although endoscopic submucosal dissection (ESD) is the preferred endoscopic resection method in the East, the adoption of this technique in the West, particularly in the United States, has faced many hurdles. Many endoscopists who routinely perform piecemeal endoscopic mucosal resection (EMR) question the utility of ESD, arguing that EMR is just as effective. While this may hold true in certain situations, the global trend in the endoscopic treatment of early esophageal squamous cell carcinoma, nodular Barrett’s esophagus (BE), and early esophageal adenocarcinoma (EAC) has clearly shifted toward ESD. In this perspective, I will summarize why ESD is preferred over EMR for these indications and explore why ESD has yet to gain widespread adoption in the United States.

The superiority of ESD over EMR has been well established in multiple publications from both Eastern and Western literature. Mejia-Perez et al, in a multicenter cohort study from eight centers in North America, compared outcomes of ESD vs EMR for BE with high-grade dysplasia (HGD) or T1a adenocarcinoma in 243 patients. ESD achieved significantly higher en bloc resection rates (89% vs 43%) and R0 resection rates (73% vs 56%), compared with EMR, along with a substantially lower recurrence/residual disease rate on follow-up (3.5% in the ESD group vs 31.4% in EMR group). Additionally, more patients required repeat endoscopic resection after EMR to treat residual or recurrent disease (EMR, 24.2% vs ESD, 3.5%; P < .001).

Han et al conducted a meta-analysis of 22 studies comparing ESD and EMR for early esophageal neoplasia, including both squamous cell carcinoma (SCC) and BE-associated lesions. ESD was associated with significantly higher curative resection rates than EMR (OR, 9.74; 95% CI, 4.83-19.62; P < .0001). Of note, lesion size was a critical factor in determining the advantage of ESD. For lesions ≤ 10 mm, curative resection rates were comparable between ESD and EMR. However, for lesions > 10 mm, ESD achieved significantly higher curative resection rates. This size-based recommendation has been adopted by the American Society of Gastrointestinal Endoscopy (ASGE) in their recent guidelines on ESD indications for esophageal lesions. ASGE guidelines favors ESD over EMR for SCC lesions > 15 mm and for nodular BE with dysplasia or early EAC > 20 mm.

ESD is particularly beneficial in patients who develop early adenocarcinoma after RFA or EMR. Mesureur et al evaluated the efficacy of salvage ESD for Barrett’s recurrence or residual BE following RFA. In their multicenter retrospective study of 56 patients, salvage ESD achieved an en bloc resection rate of 89.3%, despite significant fibrosis, with an R0 resection rate of 66%. At a median follow-up of 14 months, most patients remained in endoscopic remission without the need for esophagectomy.

Combining ESD with RFA has also been shown to accelerate the eradication of BE with dysplasia while reducing the number of required sessions. Our group demonstrated the high efficacy of ESD followed by RFA in 18 patients, most of whom had long-segment BE with HGD or EAC. On average, patients required only one to two RFA sessions after ESD to achieve complete eradication of intestinal metaplasia (CE-IM). Over a median follow-up of 42.5 months (IQR, 28-59.25), complete eradication of early esophageal cancer was achieved in 13 patients (100%), eradication of dysplasia in 15 patients (100%), and CE-IM in 14 patients (77.8%).

Despite the overwhelming evidence supporting ESD and the strong endorsement from professional societies, adoption in the West continues to lag. Several factors contribute to this gap. First, ESD has a steep learning curve. Our data showed that, on average, an untutored practitioner achieved competency after 150-250 procedures, a finding corroborated by other US groups.

Second, there is no specific CPT code for ESD in the United States. Physicians are forced to bill the procedure as EMR or use an unlisted code, resulting in reimbursement that does not reflect the time and complexity of the procedure. Our group showed that physician reimbursement for ESD is highly variable, ranging from $50 to $800 per case, depending on insurance type.

Third, the increasing emphasis on productivity and RVU generation in academic settings has hindered the growth of ESD training in many institutions. Still, the outlook for ESD in the United States remains encouraging. Multiple industry-sponsored training courses are held annually, and professional societies are investing heavily in expanding access to structured education in ESD. Industry is also innovating devices that improve procedural efficiency and safety. Adopting novel approaches, such as traction-assisted ESD, has made the technique more appealing to endoscopists concerned about long procedure times. For example, our group proposed a standardized esophageal ESD technique that incorporates specimen self-retraction. This method improves both safety and speed and has helped address several procedural challenges. We’ve demonstrated that consistency in technique can substantially expedite esophageal ESD.

Fast forward 5 years: We anticipate a dedicated CPT code for ESD, broader access to advanced resection tools, and an expanding number of fellowships offering structured ESD training. These developments are poised to eliminate many of the current barriers. In summary, with robust data supporting the efficacy of ESD in early esophageal cancer, the focus in the United States should shift toward mastering and integrating the technique, rather than dismissing it in favor of piecemeal EMR.

Dr. Othman is chief of the gastroenterology and hepatology section at Baylor College of Medicine and Medicine Subspecialities Service Line Chief at Baylor St Luke’s Medical Center, both in Houston. He declares no conflicts of interest.

Dear colleagues,

Many of us diagnose and treat patients with Barrett’s esophagus, estimated to affect up to 5.6% of the US adult population. There has been an expanding array of tools to help diagnose and effectively treat Barrett’s esophagus with dysplasia and malignancy. In particular, endoscopic submucosal dissection (ESD) has emerged as an important method for treating early cancer in the gastrointestinal tract.

But how do we incorporate ESD into our algorithm for management, especially with the popularity and effectiveness of endoscopic mucosal resection (EMR)? In this issue of Perspectives we aim to provide context for the use of ESD, as compared with EMR. Dr. Silvio de Melo discusses his preferred EMR technique and its many advantages in the management of BE, including for residual or refractory areas. In contrast, Dr. Mohamed Othman reviews the power of ESD and when we should consider this approach over EMR. We hope these discussions will facilitate your care for patients with Barrett’s esophagus.

We also welcome your thoughts on this topic — join the conversation on X at @AGA_GIHN. 

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.

Endoscopic Mucosal Resection: The ‘Workhorse’ for Patient Care

BY SILVIO W. DE MELO JR, MD, AGAF

Barrett’s esophagus (BE) remains an important clinical problem, being one of the modifiable risk factors for esophageal adenocarcinoma. The care for BE is complex and requires several steps to correctly formulate a therapeutic plan. It starts with a proper endoscopic examination. It is recommended to spend at least 1 minute inspecting and evaluating every centimeter of the salmon-colored epithelium, looking for change in vascular pattern, erosions/ulcers, nodules, and/or masses. After the inspection, random biopsies every 1-2 cm plus targeted biopsies will guide you. It is still controversial if the addition of other sampling strategies, such as brushings or confocal endomicroscopy, is needed.

The introduction of radiofrequency ablation (RFA) was paramount in popularizing the treatment options for BE and sunsetting the previous dominant modality, photodynamic therapy (PDT). RFA proved to have a superior clinical efficacy in replacing the intestinal metaplasia/BE with neosquamous epithelium while boosting a much better safety profile, compared with PDT. However, RFA is most efficacious for “flat BE” and it is not an effective, nor recommended, method to treat nodular BE or early cancer, such as carcinoma in situ or nodular high-grade dysplasia. Endoscopic mucosal resection (EMR) is utilized to overcome those limitations.

There are several techniques utilized for EMR:

• The lift and snare technique.
• The snare-in-cap technique.
• The Band-snare technique.

The free-hand submucosal lift and snare is not frequently used in the esophagus. It is difficult to maintain visualization while being confident that one has the whole lesion inside the snare and that the distal (anal side) part of the lesion is free of any unwanted tissue (to minimize complications such as perforations or unwelcomed gastric resections). It is difficult after the first resection to lift an adjacent area, as the fluid easily leaks from the first resected spot, thus removing larger lesions in piece-meal fashion is challenging. This technique can be used in small (in my personal experience, less than 5 mm) lesions, but, given that there are better and safer alternatives, I almost never use this technique for my esophageal EMR cases. I prefer to use the band-snare technique even for lesions under 5 mm.

The snare-in-cap technique has been utilized in the esophagus. In this technique, a cap is attached to the distal end of the scope and the size of the resection is determined by the size of the cap, usually under 1.5 cm. Because of the risk of perforation without previous lifting, it is required that the lesion is lifted with a submucosal fluid, saline or any Food and Drug Administration–approved EMR solution. The lesion is then suctioned inside the cap where the snare had been previously opened inside the cap, the snare is closed, and the tissue is resected. The same limitations regarding the inability to remove larger lesions (greater than 1.5 cm) because of the challenge in lifting the adjacent area applies here. However, the perforation risk for this technique is higher than the traditional lift and the band and snare techniques. Thus, this technique has fallen out of favor for most endoscopists.

The third technique (band-snare EMR) is the one that most endoscopists use for endoscopic mucosal resection. It is a small variation of the already time-tested and very familiar procedure of esophageal variceal band ligation (EVL). There are multiple commercially available kits for esophageal EMR. The kit contains the chamber with the bands and a proprietary hexagonal snare used to resect the specimen.

The advantages of this technique are:

• It is widely commercially available.
• It builds on a familiar procedure, EVL, therefore the learning curve is short.
• The set-up is quick and the procedure can be completed safely and effectively.
• There is no need for injecting the submucosal with a lifting solution.
• Despite the band having a size limitation of 1 cm, one can remove larger lesions by repeating the band and resect process, using the rosette technique.

Band-snare EMR also has limitations:

• There are only six bands on each chamber. Depending on the size of the lesion, one may need to use multiple kits.
• It is not suitable for en bloc resection of lesions greater than 1 cm.

My experience with band EMR is that we can complete the procedure in under 1 hour. The dreaded complication of perforation occurs in under 1% of cases, most bleeding episodes can easily be controlled endoscopically, and the risk of post-EMR stricture is minimal. Therefore, band EMR is the most used technique for esophageal endoscopic resections.

Esophageal EMR is also effective for other indications in BE therapy, such as residual and recurrent BE. Band-snare EMR can be used for an en bloc resection or rosette technique for the areas resistant to ablation therapies with great success and safety.

From a financial standpoint, comparing EMR with endoscopic submucosal dissection (ESD), EMR is the superior strategy given that EMR is widely available, has a much shorter learning curve, has a greater safety profile, is applicable to a wider variety of indications, and has a more favorable return on investment. EMR should be the workhorse for the care of patients with BE, reserving ESD for specific indications.

In summary, there is no “one-size-fits-all” endoscopic therapy in the care of BE. Most Barrett’s patients can be successfully treated with a combination of ablation plus EMR, reserving ESD for select cases.

Dr. de Melo is section chief of gastroenterology at the Orlando VA Healthcare System, Orlando, Florida. He declares no conflicts of interest.

ESD Over EMR for Resecting Esophageal Lesions

BY MOHAMED O. OTHMAN, MD, AGAF

Although endoscopic submucosal dissection (ESD) is the preferred endoscopic resection method in the East, the adoption of this technique in the West, particularly in the United States, has faced many hurdles. Many endoscopists who routinely perform piecemeal endoscopic mucosal resection (EMR) question the utility of ESD, arguing that EMR is just as effective. While this may hold true in certain situations, the global trend in the endoscopic treatment of early esophageal squamous cell carcinoma, nodular Barrett’s esophagus (BE), and early esophageal adenocarcinoma (EAC) has clearly shifted toward ESD. In this perspective, I will summarize why ESD is preferred over EMR for these indications and explore why ESD has yet to gain widespread adoption in the United States.

The superiority of ESD over EMR has been well established in multiple publications from both Eastern and Western literature. Mejia-Perez et al, in a multicenter cohort study from eight centers in North America, compared outcomes of ESD vs EMR for BE with high-grade dysplasia (HGD) or T1a adenocarcinoma in 243 patients. ESD achieved significantly higher en bloc resection rates (89% vs 43%) and R0 resection rates (73% vs 56%), compared with EMR, along with a substantially lower recurrence/residual disease rate on follow-up (3.5% in the ESD group vs 31.4% in EMR group). Additionally, more patients required repeat endoscopic resection after EMR to treat residual or recurrent disease (EMR, 24.2% vs ESD, 3.5%; P < .001).

Han et al conducted a meta-analysis of 22 studies comparing ESD and EMR for early esophageal neoplasia, including both squamous cell carcinoma (SCC) and BE-associated lesions. ESD was associated with significantly higher curative resection rates than EMR (OR, 9.74; 95% CI, 4.83-19.62; P < .0001). Of note, lesion size was a critical factor in determining the advantage of ESD. For lesions ≤ 10 mm, curative resection rates were comparable between ESD and EMR. However, for lesions > 10 mm, ESD achieved significantly higher curative resection rates. This size-based recommendation has been adopted by the American Society of Gastrointestinal Endoscopy (ASGE) in their recent guidelines on ESD indications for esophageal lesions. ASGE guidelines favors ESD over EMR for SCC lesions > 15 mm and for nodular BE with dysplasia or early EAC > 20 mm.

ESD is particularly beneficial in patients who develop early adenocarcinoma after RFA or EMR. Mesureur et al evaluated the efficacy of salvage ESD for Barrett’s recurrence or residual BE following RFA. In their multicenter retrospective study of 56 patients, salvage ESD achieved an en bloc resection rate of 89.3%, despite significant fibrosis, with an R0 resection rate of 66%. At a median follow-up of 14 months, most patients remained in endoscopic remission without the need for esophagectomy.

Combining ESD with RFA has also been shown to accelerate the eradication of BE with dysplasia while reducing the number of required sessions. Our group demonstrated the high efficacy of ESD followed by RFA in 18 patients, most of whom had long-segment BE with HGD or EAC. On average, patients required only one to two RFA sessions after ESD to achieve complete eradication of intestinal metaplasia (CE-IM). Over a median follow-up of 42.5 months (IQR, 28-59.25), complete eradication of early esophageal cancer was achieved in 13 patients (100%), eradication of dysplasia in 15 patients (100%), and CE-IM in 14 patients (77.8%).

Despite the overwhelming evidence supporting ESD and the strong endorsement from professional societies, adoption in the West continues to lag. Several factors contribute to this gap. First, ESD has a steep learning curve. Our data showed that, on average, an untutored practitioner achieved competency after 150-250 procedures, a finding corroborated by other US groups.

Second, there is no specific CPT code for ESD in the United States. Physicians are forced to bill the procedure as EMR or use an unlisted code, resulting in reimbursement that does not reflect the time and complexity of the procedure. Our group showed that physician reimbursement for ESD is highly variable, ranging from $50 to $800 per case, depending on insurance type.

Third, the increasing emphasis on productivity and RVU generation in academic settings has hindered the growth of ESD training in many institutions. Still, the outlook for ESD in the United States remains encouraging. Multiple industry-sponsored training courses are held annually, and professional societies are investing heavily in expanding access to structured education in ESD. Industry is also innovating devices that improve procedural efficiency and safety. Adopting novel approaches, such as traction-assisted ESD, has made the technique more appealing to endoscopists concerned about long procedure times. For example, our group proposed a standardized esophageal ESD technique that incorporates specimen self-retraction. This method improves both safety and speed and has helped address several procedural challenges. We’ve demonstrated that consistency in technique can substantially expedite esophageal ESD.

Fast forward 5 years: We anticipate a dedicated CPT code for ESD, broader access to advanced resection tools, and an expanding number of fellowships offering structured ESD training. These developments are poised to eliminate many of the current barriers. In summary, with robust data supporting the efficacy of ESD in early esophageal cancer, the focus in the United States should shift toward mastering and integrating the technique, rather than dismissing it in favor of piecemeal EMR.

Dr. Othman is chief of the gastroenterology and hepatology section at Baylor College of Medicine and Medicine Subspecialities Service Line Chief at Baylor St Luke’s Medical Center, both in Houston. He declares no conflicts of interest.