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Half of Patients Skip Repeat Stool Tests for CRC Screening
A large real-world study found that
Among those who did repeat the test, the average delay was 3 months before COVID and increased to 5 months during the pandemic, the authors reported in BMJ Public Health.
“Stool tests are relatively easy to complete at home and mailed for testing, and they are inexpensive, but they must be completed annually. In contrast, colonoscopies are more invasive and require more time away from work but only need to be repeated every 5-10 years,” Staci J Wendt, PhD, director, health research accelerator, Providence Research Network, Providence, Rhode Island, told GI & Hepatology News.
In the end, “the best colorectal cancer screening test is the one that gets done,” Wendt said.
“This is why we stress the importance of patients and their doctor having these discussions together and deciding which screening is the most preferred method for the individual patient,” she added.
Stool Tests Gaining Traction
Adults are increasingly turning to at-home stool tests for CRC screening — a trend that accelerated during the pandemic. Yet, there is limited data on whether patients undergo repeat stool tests following initial negative test results.
Wendt and her colleagues documented rates of repeat preventative stool tests by analyzing electronic medical records from Providence St Joseph Health, a large health system with 51 hospitals and over 1000 clinics across seven western US states.
They divided their analysis into two periods based on the onset of the pandemic. The pre-COVID onset period spanned January 2018 to February 2020 and the post-COVID period spanned March 2020 to February 2022.
“The pandemic is a salient time to conduct this study because it resulted in a dramatic decrease in colonoscopies, which were partially replaced by stool tests. This partial replacement of colonoscopies by stool tests has led other studies to conclude that stool tests mitigated gaps in CRC screening during the pandemic. But gaps may persist if patients do not undergo repeat testing,” the study team explained.
Their sample included 403,085 patients. Among those with an initial negative stool test, the share who obtained a timely repeat screening ranged from 38% to 49% across the study years, confirming that “most patients do not undergo the recommended repeat screening after their initial stool test,” the researchers said.
Among adults who do a repeat test, delays were common. The average lag to the follow-up test was 3months on average, increasing to about 5 months amid COVID — almost half as long as the preventative screening period of stool tests (12 months).
“These gaps could delay detection of CRC and subsequent treatment, potentially resulting in higher mortality. These gaps are particularly important as more and more patients use stool tests instead of colonoscopes for CRC screening,” the researchers wrote.
Screening patterns shifted markedly during the pandemic.
Not surprisingly, the volume of colonoscopies declined substantially after the onset of the pandemic and stayed low through the study’s end. In contrast, the volume of at-home stool tests was increasing before the pandemic and accelerated during the pandemic.
“Given this increase in stool tests, it will be increasingly important to focus on improving long-term adherence to screening through outreach, policies and programs,” the researchers said.
A Multilevel Approach
Wendt said health systems that are incorporating proactive measures like sending stool kits to patients who are eligible for screening, should ensure that these screening kits and information are sent annually and that it is stressed that the screening must happen every year.
Reached for comment, Aasma Shaukat, MD, MPH, AGAF, director of outcomes research, Division of Gastroenterology and Hepatology, NYU Langone Health, New York City, who wasn’t involved in the study, said the poor adherence to repeat stool tests for CRC screening seen in this study is “not surprising.”
“We know that adherence goes down with each consecutive screening round and what is really needed is an organized program to keep the level of adherence up,” Shaukat told GI & Hepatology News.
Shaukat agreed that boosting adherence to stool tests requires a “multilevel approach.”
She cited the success of the CRC screening program implemented across Kaiser Permanente Northern California. The program includes proactive and targeted outreach to members who are overdue for screening and mailed fecal immunochemical test kits for at-home use.
As reported previously by GI & Hepatology News, the program has made a huge difference in CRC incidence, deaths, and racial disparities.
The program has doubled the proportion of people up to date with screening. And, within about 10 years, cancer rates were cut by a third, deaths were halved and largely eliminated long-standing differences by race and ethnicity.
The study had no commercial funding. Wendt and Shaukat declared having no relevant disclosures.
A version of this article appeared on Medscape.com.
A large real-world study found that
Among those who did repeat the test, the average delay was 3 months before COVID and increased to 5 months during the pandemic, the authors reported in BMJ Public Health.
“Stool tests are relatively easy to complete at home and mailed for testing, and they are inexpensive, but they must be completed annually. In contrast, colonoscopies are more invasive and require more time away from work but only need to be repeated every 5-10 years,” Staci J Wendt, PhD, director, health research accelerator, Providence Research Network, Providence, Rhode Island, told GI & Hepatology News.
In the end, “the best colorectal cancer screening test is the one that gets done,” Wendt said.
“This is why we stress the importance of patients and their doctor having these discussions together and deciding which screening is the most preferred method for the individual patient,” she added.
Stool Tests Gaining Traction
Adults are increasingly turning to at-home stool tests for CRC screening — a trend that accelerated during the pandemic. Yet, there is limited data on whether patients undergo repeat stool tests following initial negative test results.
Wendt and her colleagues documented rates of repeat preventative stool tests by analyzing electronic medical records from Providence St Joseph Health, a large health system with 51 hospitals and over 1000 clinics across seven western US states.
They divided their analysis into two periods based on the onset of the pandemic. The pre-COVID onset period spanned January 2018 to February 2020 and the post-COVID period spanned March 2020 to February 2022.
“The pandemic is a salient time to conduct this study because it resulted in a dramatic decrease in colonoscopies, which were partially replaced by stool tests. This partial replacement of colonoscopies by stool tests has led other studies to conclude that stool tests mitigated gaps in CRC screening during the pandemic. But gaps may persist if patients do not undergo repeat testing,” the study team explained.
Their sample included 403,085 patients. Among those with an initial negative stool test, the share who obtained a timely repeat screening ranged from 38% to 49% across the study years, confirming that “most patients do not undergo the recommended repeat screening after their initial stool test,” the researchers said.
Among adults who do a repeat test, delays were common. The average lag to the follow-up test was 3months on average, increasing to about 5 months amid COVID — almost half as long as the preventative screening period of stool tests (12 months).
“These gaps could delay detection of CRC and subsequent treatment, potentially resulting in higher mortality. These gaps are particularly important as more and more patients use stool tests instead of colonoscopes for CRC screening,” the researchers wrote.
Screening patterns shifted markedly during the pandemic.
Not surprisingly, the volume of colonoscopies declined substantially after the onset of the pandemic and stayed low through the study’s end. In contrast, the volume of at-home stool tests was increasing before the pandemic and accelerated during the pandemic.
“Given this increase in stool tests, it will be increasingly important to focus on improving long-term adherence to screening through outreach, policies and programs,” the researchers said.
A Multilevel Approach
Wendt said health systems that are incorporating proactive measures like sending stool kits to patients who are eligible for screening, should ensure that these screening kits and information are sent annually and that it is stressed that the screening must happen every year.
Reached for comment, Aasma Shaukat, MD, MPH, AGAF, director of outcomes research, Division of Gastroenterology and Hepatology, NYU Langone Health, New York City, who wasn’t involved in the study, said the poor adherence to repeat stool tests for CRC screening seen in this study is “not surprising.”
“We know that adherence goes down with each consecutive screening round and what is really needed is an organized program to keep the level of adherence up,” Shaukat told GI & Hepatology News.
Shaukat agreed that boosting adherence to stool tests requires a “multilevel approach.”
She cited the success of the CRC screening program implemented across Kaiser Permanente Northern California. The program includes proactive and targeted outreach to members who are overdue for screening and mailed fecal immunochemical test kits for at-home use.
As reported previously by GI & Hepatology News, the program has made a huge difference in CRC incidence, deaths, and racial disparities.
The program has doubled the proportion of people up to date with screening. And, within about 10 years, cancer rates were cut by a third, deaths were halved and largely eliminated long-standing differences by race and ethnicity.
The study had no commercial funding. Wendt and Shaukat declared having no relevant disclosures.
A version of this article appeared on Medscape.com.
A large real-world study found that
Among those who did repeat the test, the average delay was 3 months before COVID and increased to 5 months during the pandemic, the authors reported in BMJ Public Health.
“Stool tests are relatively easy to complete at home and mailed for testing, and they are inexpensive, but they must be completed annually. In contrast, colonoscopies are more invasive and require more time away from work but only need to be repeated every 5-10 years,” Staci J Wendt, PhD, director, health research accelerator, Providence Research Network, Providence, Rhode Island, told GI & Hepatology News.
In the end, “the best colorectal cancer screening test is the one that gets done,” Wendt said.
“This is why we stress the importance of patients and their doctor having these discussions together and deciding which screening is the most preferred method for the individual patient,” she added.
Stool Tests Gaining Traction
Adults are increasingly turning to at-home stool tests for CRC screening — a trend that accelerated during the pandemic. Yet, there is limited data on whether patients undergo repeat stool tests following initial negative test results.
Wendt and her colleagues documented rates of repeat preventative stool tests by analyzing electronic medical records from Providence St Joseph Health, a large health system with 51 hospitals and over 1000 clinics across seven western US states.
They divided their analysis into two periods based on the onset of the pandemic. The pre-COVID onset period spanned January 2018 to February 2020 and the post-COVID period spanned March 2020 to February 2022.
“The pandemic is a salient time to conduct this study because it resulted in a dramatic decrease in colonoscopies, which were partially replaced by stool tests. This partial replacement of colonoscopies by stool tests has led other studies to conclude that stool tests mitigated gaps in CRC screening during the pandemic. But gaps may persist if patients do not undergo repeat testing,” the study team explained.
Their sample included 403,085 patients. Among those with an initial negative stool test, the share who obtained a timely repeat screening ranged from 38% to 49% across the study years, confirming that “most patients do not undergo the recommended repeat screening after their initial stool test,” the researchers said.
Among adults who do a repeat test, delays were common. The average lag to the follow-up test was 3months on average, increasing to about 5 months amid COVID — almost half as long as the preventative screening period of stool tests (12 months).
“These gaps could delay detection of CRC and subsequent treatment, potentially resulting in higher mortality. These gaps are particularly important as more and more patients use stool tests instead of colonoscopes for CRC screening,” the researchers wrote.
Screening patterns shifted markedly during the pandemic.
Not surprisingly, the volume of colonoscopies declined substantially after the onset of the pandemic and stayed low through the study’s end. In contrast, the volume of at-home stool tests was increasing before the pandemic and accelerated during the pandemic.
“Given this increase in stool tests, it will be increasingly important to focus on improving long-term adherence to screening through outreach, policies and programs,” the researchers said.
A Multilevel Approach
Wendt said health systems that are incorporating proactive measures like sending stool kits to patients who are eligible for screening, should ensure that these screening kits and information are sent annually and that it is stressed that the screening must happen every year.
Reached for comment, Aasma Shaukat, MD, MPH, AGAF, director of outcomes research, Division of Gastroenterology and Hepatology, NYU Langone Health, New York City, who wasn’t involved in the study, said the poor adherence to repeat stool tests for CRC screening seen in this study is “not surprising.”
“We know that adherence goes down with each consecutive screening round and what is really needed is an organized program to keep the level of adherence up,” Shaukat told GI & Hepatology News.
Shaukat agreed that boosting adherence to stool tests requires a “multilevel approach.”
She cited the success of the CRC screening program implemented across Kaiser Permanente Northern California. The program includes proactive and targeted outreach to members who are overdue for screening and mailed fecal immunochemical test kits for at-home use.
As reported previously by GI & Hepatology News, the program has made a huge difference in CRC incidence, deaths, and racial disparities.
The program has doubled the proportion of people up to date with screening. And, within about 10 years, cancer rates were cut by a third, deaths were halved and largely eliminated long-standing differences by race and ethnicity.
The study had no commercial funding. Wendt and Shaukat declared having no relevant disclosures.
A version of this article appeared on Medscape.com.
Anti-TNF Exposure Influences Efficacy of Subsequent Therapies in UC
, based on results of a large meta-analysis.
Patients previously treated with TNF antagonists were less likely to respond to lymphocyte trafficking inhibitors but more likely to achieve remission on Janus kinase (JAK) inhibitors, Han Hee Lee, MD, PhD, of the University of California San Diego, and colleagues reported.
“Treatment options for patients with moderate-severe ulcerative colitis have increased in the last decade with the availability of six different classes of medications,” investigators wrote in Clinical Gastroenterology and Hepatology (2024 Dec. doi:10.1016/j.cgh.2024.12.007). “There is wide interindividual variability in response to specific medications, and drivers of this heterogeneity are critical to understand to be able to choose the best therapy for each individual patient.”
To learn more about the impacts of anti-TNF exposure on subsequent advanced therapies, the investigators conducted a systematic review and meta-analysis of 17 phase 2 and 3 trials. The dataset included 8,871 adults with moderate-severe UC.
The primary outcome was induction of clinical remission at 6–14 weeks, most often defined as a Mayo Clinic score of 2 or lower with no subscore greater than 1. Endoscopic improvement, generally defined as a Mayo endoscopic subscore of 0 or 1, was evaluated as a secondary endpoint.
Advanced therapies were grouped by mechanism of action, including lymphocyte trafficking inhibitors, JAK inhibitors, and interleukin (IL)-12/23 and IL-23 antagonists. Odds ratios for treatment versus placebo were calculated separately for each subgroup, and a ratio of odds ratios was then used to assess whether prior TNF exposure modified drug effect. Analyses were conducted on an intention-to-treat basis, restricted to approved dosing when multiple regimens were tested.
Across five trials of lymphocyte trafficking inhibitors including 2,046 patients, efficacy was significantly greater in TNF-naïve patients compared with those who had prior TNF exposure. The odds of achieving clinical remission were nearly doubled in the TNF-naïve group (ratio of odds ratios [ROR], 1.88; 95% CI, 1.02–3.49).
In six trials of JAK inhibitors including 3,015 patients, remission rates were higher among TNF-exposed patients com-pared with TNF-naïve patients (ROR, 0.47; 95% CI, 0.22–1.01).
In six trials of IL-12/23 and IL-23 antagonists, including 3,810 patients, prior TNF exposure did not significantly modify treatment outcomes (ROR, 1.07; 95% CI, 0.64–1.80). Within individual trials, ustekinumab showed a trend toward great-er efficacy in TNF-exposed patients, whereas selective IL-23 antagonists performed similarly regardless of TNF exposure history.
Secondary analyses of endoscopic improvement yielded results consistent with the primary endpoint. Statistical heterogeneity across trials was minimal, and all included studies were rated at low risk of bias.
The investigators noted several limitations. For example, therapies were grouped broadly by mechanism of action, although specific biologic effects could potentially differ within groups. The analysis also could not account for patients who had failed two or more classes of advanced therapy, which may independently reduce the likelihood of response.
Still, Lee and colleagues suggested that the findings deserve a closer look.
“[T]here is significant heterogeneity of treatment efficacy for induction of remission with different advanced therapies in patients with moderate-severe UC based on prior exposure to TNF antagonists,” they concluded. “Future studies on the mechanistic insight for these intriguing observations are warranted.”
The study was supported by the Leona and Harry B. Helmsley Trust, the National Institutes of Health, and the Centers for Disease Control and Prevention. The investigators disclosed relationships with AbbVie, Ferring, Pfizer, and others.
, based on results of a large meta-analysis.
Patients previously treated with TNF antagonists were less likely to respond to lymphocyte trafficking inhibitors but more likely to achieve remission on Janus kinase (JAK) inhibitors, Han Hee Lee, MD, PhD, of the University of California San Diego, and colleagues reported.
“Treatment options for patients with moderate-severe ulcerative colitis have increased in the last decade with the availability of six different classes of medications,” investigators wrote in Clinical Gastroenterology and Hepatology (2024 Dec. doi:10.1016/j.cgh.2024.12.007). “There is wide interindividual variability in response to specific medications, and drivers of this heterogeneity are critical to understand to be able to choose the best therapy for each individual patient.”
To learn more about the impacts of anti-TNF exposure on subsequent advanced therapies, the investigators conducted a systematic review and meta-analysis of 17 phase 2 and 3 trials. The dataset included 8,871 adults with moderate-severe UC.
The primary outcome was induction of clinical remission at 6–14 weeks, most often defined as a Mayo Clinic score of 2 or lower with no subscore greater than 1. Endoscopic improvement, generally defined as a Mayo endoscopic subscore of 0 or 1, was evaluated as a secondary endpoint.
Advanced therapies were grouped by mechanism of action, including lymphocyte trafficking inhibitors, JAK inhibitors, and interleukin (IL)-12/23 and IL-23 antagonists. Odds ratios for treatment versus placebo were calculated separately for each subgroup, and a ratio of odds ratios was then used to assess whether prior TNF exposure modified drug effect. Analyses were conducted on an intention-to-treat basis, restricted to approved dosing when multiple regimens were tested.
Across five trials of lymphocyte trafficking inhibitors including 2,046 patients, efficacy was significantly greater in TNF-naïve patients compared with those who had prior TNF exposure. The odds of achieving clinical remission were nearly doubled in the TNF-naïve group (ratio of odds ratios [ROR], 1.88; 95% CI, 1.02–3.49).
In six trials of JAK inhibitors including 3,015 patients, remission rates were higher among TNF-exposed patients com-pared with TNF-naïve patients (ROR, 0.47; 95% CI, 0.22–1.01).
In six trials of IL-12/23 and IL-23 antagonists, including 3,810 patients, prior TNF exposure did not significantly modify treatment outcomes (ROR, 1.07; 95% CI, 0.64–1.80). Within individual trials, ustekinumab showed a trend toward great-er efficacy in TNF-exposed patients, whereas selective IL-23 antagonists performed similarly regardless of TNF exposure history.
Secondary analyses of endoscopic improvement yielded results consistent with the primary endpoint. Statistical heterogeneity across trials was minimal, and all included studies were rated at low risk of bias.
The investigators noted several limitations. For example, therapies were grouped broadly by mechanism of action, although specific biologic effects could potentially differ within groups. The analysis also could not account for patients who had failed two or more classes of advanced therapy, which may independently reduce the likelihood of response.
Still, Lee and colleagues suggested that the findings deserve a closer look.
“[T]here is significant heterogeneity of treatment efficacy for induction of remission with different advanced therapies in patients with moderate-severe UC based on prior exposure to TNF antagonists,” they concluded. “Future studies on the mechanistic insight for these intriguing observations are warranted.”
The study was supported by the Leona and Harry B. Helmsley Trust, the National Institutes of Health, and the Centers for Disease Control and Prevention. The investigators disclosed relationships with AbbVie, Ferring, Pfizer, and others.
, based on results of a large meta-analysis.
Patients previously treated with TNF antagonists were less likely to respond to lymphocyte trafficking inhibitors but more likely to achieve remission on Janus kinase (JAK) inhibitors, Han Hee Lee, MD, PhD, of the University of California San Diego, and colleagues reported.
“Treatment options for patients with moderate-severe ulcerative colitis have increased in the last decade with the availability of six different classes of medications,” investigators wrote in Clinical Gastroenterology and Hepatology (2024 Dec. doi:10.1016/j.cgh.2024.12.007). “There is wide interindividual variability in response to specific medications, and drivers of this heterogeneity are critical to understand to be able to choose the best therapy for each individual patient.”
To learn more about the impacts of anti-TNF exposure on subsequent advanced therapies, the investigators conducted a systematic review and meta-analysis of 17 phase 2 and 3 trials. The dataset included 8,871 adults with moderate-severe UC.
The primary outcome was induction of clinical remission at 6–14 weeks, most often defined as a Mayo Clinic score of 2 or lower with no subscore greater than 1. Endoscopic improvement, generally defined as a Mayo endoscopic subscore of 0 or 1, was evaluated as a secondary endpoint.
Advanced therapies were grouped by mechanism of action, including lymphocyte trafficking inhibitors, JAK inhibitors, and interleukin (IL)-12/23 and IL-23 antagonists. Odds ratios for treatment versus placebo were calculated separately for each subgroup, and a ratio of odds ratios was then used to assess whether prior TNF exposure modified drug effect. Analyses were conducted on an intention-to-treat basis, restricted to approved dosing when multiple regimens were tested.
Across five trials of lymphocyte trafficking inhibitors including 2,046 patients, efficacy was significantly greater in TNF-naïve patients compared with those who had prior TNF exposure. The odds of achieving clinical remission were nearly doubled in the TNF-naïve group (ratio of odds ratios [ROR], 1.88; 95% CI, 1.02–3.49).
In six trials of JAK inhibitors including 3,015 patients, remission rates were higher among TNF-exposed patients com-pared with TNF-naïve patients (ROR, 0.47; 95% CI, 0.22–1.01).
In six trials of IL-12/23 and IL-23 antagonists, including 3,810 patients, prior TNF exposure did not significantly modify treatment outcomes (ROR, 1.07; 95% CI, 0.64–1.80). Within individual trials, ustekinumab showed a trend toward great-er efficacy in TNF-exposed patients, whereas selective IL-23 antagonists performed similarly regardless of TNF exposure history.
Secondary analyses of endoscopic improvement yielded results consistent with the primary endpoint. Statistical heterogeneity across trials was minimal, and all included studies were rated at low risk of bias.
The investigators noted several limitations. For example, therapies were grouped broadly by mechanism of action, although specific biologic effects could potentially differ within groups. The analysis also could not account for patients who had failed two or more classes of advanced therapy, which may independently reduce the likelihood of response.
Still, Lee and colleagues suggested that the findings deserve a closer look.
“[T]here is significant heterogeneity of treatment efficacy for induction of remission with different advanced therapies in patients with moderate-severe UC based on prior exposure to TNF antagonists,” they concluded. “Future studies on the mechanistic insight for these intriguing observations are warranted.”
The study was supported by the Leona and Harry B. Helmsley Trust, the National Institutes of Health, and the Centers for Disease Control and Prevention. The investigators disclosed relationships with AbbVie, Ferring, Pfizer, and others.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Making Surgery Safer for Patients With Cirrhosis
, according to an updated guideline from the American College of Gastroenterology.
Procedures such as cholecystectomy and hernia repair can be safely performed if precautions are taken, but surgical decision-making in patients with cirrhosis calls for a nuanced approach that takes into account several factors, including severity of liver disease, nonhepatic comorbidities, and procedure-specific considerations, wrote lead author Nadim Mahmud, MD, assistant professor of medicine and epidemiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, in the American Journal of Gastroenterology.
“Patients with cirrhosis face substantially higher risks from surgery than those without liver disease, and careful guidance and risk stratification are essential,” Mahmud told GI & Hepatology News.
“At the same time, more patients are living longer with cirrhosis and increasingly require nonhepatic surgeries. Clinicians need up-to-date, practical recommendations that go beyond liver scores alone by integrating liver disease severity, comorbidities, and procedure-specific risk,” Mahmud said. The new guideline provides a comprehensive framework to help ensure that patients with cirrhosis undergo necessary operations, while managing preventable complications, he explained.
The guideline includes four recommendations for preoperative care, of which three are conditional and one is strong. The strong recommendation calls for the use of thrombopoietin receptor agonists, dosed according to baseline platelet count, in patients with cirrhosis and severe thrombocytopenia who are undergoing invasive procedures to reduce the need for perioperative transfusions and potentially reduce the risk for periprocedural bleeding.
Three conditional recommendations:
- For patients with compensated cirrhosis and unclear presence of clinically significant portal hypertension (CSPH), preoperative liver stiffness measurement and platelet count assessment are recommended to determine whether CSPH is present due to increased perioperative risks associated with the condition. Cross-sectional imaging should be conducted to identify portosystemic collaterals and complications of portal hypertension.
- For patients with cirrhosis and CSPH with alternative indications for transjugular intrahepatic portosystemic shunt (TIPS), such as large varices or refractory ascites, preoperative TIPS is suggested to reduce postoperative morbidity and mortality attributable to portal hypertension.
- For patients with cirrhosis undergoing major hepatic surgery, referral to a high-volume liver surgery or transplant center, when feasible, is recommended.
The guideline also advises on 26 key concepts, including nutrition, alcohol and tobacco use, comorbidities such as frailty and sarcopenia, and preoperative treatment of liver disease drivers such as hepatitis B, hepatitis C, and autoimmune hepatitis.
What’s New and Notable?
New elements of the guideline include use of cirrhosis-specific risk calculators, especially the Veterans Outcomes and Costs Associated with Liver disease (VOCAL)-Penn Score, to estimate operative risk and facilitate shared decision-making regarding surgery. The VOCAL-Penn Score, developed by Mahmud and colleagues at the University of Pennsylvania, incorporates surgery type and has shown superiority to older tools that often overestimate risk, Mahmud told GI & Hepatology News.
The guideline highlights standardized assessment of portal hypertension using noninvasive liver stiffness measurement plus platelet count and imaging, Mahmud said. “The guideline also underscores the importance of considering liver transplant evaluation before surgery in higher-risk patients,” he noted.
Clinicians will find clear recommendations on optimizing the perioperative period through nutritional support and structured prehabilitation, as well as the use of viscoelastic testing to guide transfusion decisions and the use of thrombopoietin-receptor agonists for severe thrombocytopenia, he added.
“Importantly, in carefully selected patients with significant portal hypertension, a preoperative transjugular intrahepatic portosystemic shunt may be reasonable, though it is not recommended broadly,” Mahmud said. “Finally, procedure-specific guidance, such as elective hernia repair after ascites control, laparoscopic cholecystectomy in well-compensated cirrhosis, and sleeve gastrectomy as the bariatric procedure of choice, helps translate risk into action,” he said.
These elements address key challenges in managing perioperative risk in patients with cirrhosis, namely miscalibrated risk estimates, inconsistent portal hypertension assessment, hemostasis management, and wide variation in practice, Mahmud noted.
Tackling Clinical Challenges
The new guideline collates the latest evidence and assessment tools to provide practical advice for clinicians to not only estimate risk but also better prepare patients with cirrhosis for surgical procedures, Peter D. Block, MD, assistant professor of medicine in the section of digestive diseases at the Yale School of Medicine, New Haven, Connecticut, told GI & Hepatology News.
“The larger and more invasive the operation, the higher the risk,” said Block, who was not involved in writing the guideline. Surgeries associated with the highest risk for patients with cirrhosis include major open abdominal operations, chest or cardiothoracic surgery, and major vascular surgeries, as well as emergency operations, for which there is less time to optimize any liver-related problems in advance, he said.
“Cirrhosis affects clotting, fluid balance, immunity, kidney function, and medication clearance, and each of these factors influence surgical risk,” Block said. “The guideline recommends combining liver-specific risk assessment scores with surgery-specific factors and clinical judgement, rather than relying on a single test,” he noted.
For elective surgeries, “the guideline provides practical pathways for when and how to optimize first, and when surgery must proceed despite higher risk,” he said.
The guideline was supported by the American College of Gastroenterology. Mahmud disclosed receiving research support from the National Institute of Diabetes and Digestive and Kidney Diseases and investigator-initiated research funding from Grifols, unrelated to the guideline. Block had no financial conflicts to disclose.
A version of this article appeared on Medscape.com
, according to an updated guideline from the American College of Gastroenterology.
Procedures such as cholecystectomy and hernia repair can be safely performed if precautions are taken, but surgical decision-making in patients with cirrhosis calls for a nuanced approach that takes into account several factors, including severity of liver disease, nonhepatic comorbidities, and procedure-specific considerations, wrote lead author Nadim Mahmud, MD, assistant professor of medicine and epidemiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, in the American Journal of Gastroenterology.
“Patients with cirrhosis face substantially higher risks from surgery than those without liver disease, and careful guidance and risk stratification are essential,” Mahmud told GI & Hepatology News.
“At the same time, more patients are living longer with cirrhosis and increasingly require nonhepatic surgeries. Clinicians need up-to-date, practical recommendations that go beyond liver scores alone by integrating liver disease severity, comorbidities, and procedure-specific risk,” Mahmud said. The new guideline provides a comprehensive framework to help ensure that patients with cirrhosis undergo necessary operations, while managing preventable complications, he explained.
The guideline includes four recommendations for preoperative care, of which three are conditional and one is strong. The strong recommendation calls for the use of thrombopoietin receptor agonists, dosed according to baseline platelet count, in patients with cirrhosis and severe thrombocytopenia who are undergoing invasive procedures to reduce the need for perioperative transfusions and potentially reduce the risk for periprocedural bleeding.
Three conditional recommendations:
- For patients with compensated cirrhosis and unclear presence of clinically significant portal hypertension (CSPH), preoperative liver stiffness measurement and platelet count assessment are recommended to determine whether CSPH is present due to increased perioperative risks associated with the condition. Cross-sectional imaging should be conducted to identify portosystemic collaterals and complications of portal hypertension.
- For patients with cirrhosis and CSPH with alternative indications for transjugular intrahepatic portosystemic shunt (TIPS), such as large varices or refractory ascites, preoperative TIPS is suggested to reduce postoperative morbidity and mortality attributable to portal hypertension.
- For patients with cirrhosis undergoing major hepatic surgery, referral to a high-volume liver surgery or transplant center, when feasible, is recommended.
The guideline also advises on 26 key concepts, including nutrition, alcohol and tobacco use, comorbidities such as frailty and sarcopenia, and preoperative treatment of liver disease drivers such as hepatitis B, hepatitis C, and autoimmune hepatitis.
What’s New and Notable?
New elements of the guideline include use of cirrhosis-specific risk calculators, especially the Veterans Outcomes and Costs Associated with Liver disease (VOCAL)-Penn Score, to estimate operative risk and facilitate shared decision-making regarding surgery. The VOCAL-Penn Score, developed by Mahmud and colleagues at the University of Pennsylvania, incorporates surgery type and has shown superiority to older tools that often overestimate risk, Mahmud told GI & Hepatology News.
The guideline highlights standardized assessment of portal hypertension using noninvasive liver stiffness measurement plus platelet count and imaging, Mahmud said. “The guideline also underscores the importance of considering liver transplant evaluation before surgery in higher-risk patients,” he noted.
Clinicians will find clear recommendations on optimizing the perioperative period through nutritional support and structured prehabilitation, as well as the use of viscoelastic testing to guide transfusion decisions and the use of thrombopoietin-receptor agonists for severe thrombocytopenia, he added.
“Importantly, in carefully selected patients with significant portal hypertension, a preoperative transjugular intrahepatic portosystemic shunt may be reasonable, though it is not recommended broadly,” Mahmud said. “Finally, procedure-specific guidance, such as elective hernia repair after ascites control, laparoscopic cholecystectomy in well-compensated cirrhosis, and sleeve gastrectomy as the bariatric procedure of choice, helps translate risk into action,” he said.
These elements address key challenges in managing perioperative risk in patients with cirrhosis, namely miscalibrated risk estimates, inconsistent portal hypertension assessment, hemostasis management, and wide variation in practice, Mahmud noted.
Tackling Clinical Challenges
The new guideline collates the latest evidence and assessment tools to provide practical advice for clinicians to not only estimate risk but also better prepare patients with cirrhosis for surgical procedures, Peter D. Block, MD, assistant professor of medicine in the section of digestive diseases at the Yale School of Medicine, New Haven, Connecticut, told GI & Hepatology News.
“The larger and more invasive the operation, the higher the risk,” said Block, who was not involved in writing the guideline. Surgeries associated with the highest risk for patients with cirrhosis include major open abdominal operations, chest or cardiothoracic surgery, and major vascular surgeries, as well as emergency operations, for which there is less time to optimize any liver-related problems in advance, he said.
“Cirrhosis affects clotting, fluid balance, immunity, kidney function, and medication clearance, and each of these factors influence surgical risk,” Block said. “The guideline recommends combining liver-specific risk assessment scores with surgery-specific factors and clinical judgement, rather than relying on a single test,” he noted.
For elective surgeries, “the guideline provides practical pathways for when and how to optimize first, and when surgery must proceed despite higher risk,” he said.
The guideline was supported by the American College of Gastroenterology. Mahmud disclosed receiving research support from the National Institute of Diabetes and Digestive and Kidney Diseases and investigator-initiated research funding from Grifols, unrelated to the guideline. Block had no financial conflicts to disclose.
A version of this article appeared on Medscape.com
, according to an updated guideline from the American College of Gastroenterology.
Procedures such as cholecystectomy and hernia repair can be safely performed if precautions are taken, but surgical decision-making in patients with cirrhosis calls for a nuanced approach that takes into account several factors, including severity of liver disease, nonhepatic comorbidities, and procedure-specific considerations, wrote lead author Nadim Mahmud, MD, assistant professor of medicine and epidemiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, in the American Journal of Gastroenterology.
“Patients with cirrhosis face substantially higher risks from surgery than those without liver disease, and careful guidance and risk stratification are essential,” Mahmud told GI & Hepatology News.
“At the same time, more patients are living longer with cirrhosis and increasingly require nonhepatic surgeries. Clinicians need up-to-date, practical recommendations that go beyond liver scores alone by integrating liver disease severity, comorbidities, and procedure-specific risk,” Mahmud said. The new guideline provides a comprehensive framework to help ensure that patients with cirrhosis undergo necessary operations, while managing preventable complications, he explained.
The guideline includes four recommendations for preoperative care, of which three are conditional and one is strong. The strong recommendation calls for the use of thrombopoietin receptor agonists, dosed according to baseline platelet count, in patients with cirrhosis and severe thrombocytopenia who are undergoing invasive procedures to reduce the need for perioperative transfusions and potentially reduce the risk for periprocedural bleeding.
Three conditional recommendations:
- For patients with compensated cirrhosis and unclear presence of clinically significant portal hypertension (CSPH), preoperative liver stiffness measurement and platelet count assessment are recommended to determine whether CSPH is present due to increased perioperative risks associated with the condition. Cross-sectional imaging should be conducted to identify portosystemic collaterals and complications of portal hypertension.
- For patients with cirrhosis and CSPH with alternative indications for transjugular intrahepatic portosystemic shunt (TIPS), such as large varices or refractory ascites, preoperative TIPS is suggested to reduce postoperative morbidity and mortality attributable to portal hypertension.
- For patients with cirrhosis undergoing major hepatic surgery, referral to a high-volume liver surgery or transplant center, when feasible, is recommended.
The guideline also advises on 26 key concepts, including nutrition, alcohol and tobacco use, comorbidities such as frailty and sarcopenia, and preoperative treatment of liver disease drivers such as hepatitis B, hepatitis C, and autoimmune hepatitis.
What’s New and Notable?
New elements of the guideline include use of cirrhosis-specific risk calculators, especially the Veterans Outcomes and Costs Associated with Liver disease (VOCAL)-Penn Score, to estimate operative risk and facilitate shared decision-making regarding surgery. The VOCAL-Penn Score, developed by Mahmud and colleagues at the University of Pennsylvania, incorporates surgery type and has shown superiority to older tools that often overestimate risk, Mahmud told GI & Hepatology News.
The guideline highlights standardized assessment of portal hypertension using noninvasive liver stiffness measurement plus platelet count and imaging, Mahmud said. “The guideline also underscores the importance of considering liver transplant evaluation before surgery in higher-risk patients,” he noted.
Clinicians will find clear recommendations on optimizing the perioperative period through nutritional support and structured prehabilitation, as well as the use of viscoelastic testing to guide transfusion decisions and the use of thrombopoietin-receptor agonists for severe thrombocytopenia, he added.
“Importantly, in carefully selected patients with significant portal hypertension, a preoperative transjugular intrahepatic portosystemic shunt may be reasonable, though it is not recommended broadly,” Mahmud said. “Finally, procedure-specific guidance, such as elective hernia repair after ascites control, laparoscopic cholecystectomy in well-compensated cirrhosis, and sleeve gastrectomy as the bariatric procedure of choice, helps translate risk into action,” he said.
These elements address key challenges in managing perioperative risk in patients with cirrhosis, namely miscalibrated risk estimates, inconsistent portal hypertension assessment, hemostasis management, and wide variation in practice, Mahmud noted.
Tackling Clinical Challenges
The new guideline collates the latest evidence and assessment tools to provide practical advice for clinicians to not only estimate risk but also better prepare patients with cirrhosis for surgical procedures, Peter D. Block, MD, assistant professor of medicine in the section of digestive diseases at the Yale School of Medicine, New Haven, Connecticut, told GI & Hepatology News.
“The larger and more invasive the operation, the higher the risk,” said Block, who was not involved in writing the guideline. Surgeries associated with the highest risk for patients with cirrhosis include major open abdominal operations, chest or cardiothoracic surgery, and major vascular surgeries, as well as emergency operations, for which there is less time to optimize any liver-related problems in advance, he said.
“Cirrhosis affects clotting, fluid balance, immunity, kidney function, and medication clearance, and each of these factors influence surgical risk,” Block said. “The guideline recommends combining liver-specific risk assessment scores with surgery-specific factors and clinical judgement, rather than relying on a single test,” he noted.
For elective surgeries, “the guideline provides practical pathways for when and how to optimize first, and when surgery must proceed despite higher risk,” he said.
The guideline was supported by the American College of Gastroenterology. Mahmud disclosed receiving research support from the National Institute of Diabetes and Digestive and Kidney Diseases and investigator-initiated research funding from Grifols, unrelated to the guideline. Block had no financial conflicts to disclose.
A version of this article appeared on Medscape.com
‘At-Need’ Endoscopy Equal to Standard Surveillance in Barrett’s Patients?
based on results of a randomized controlled trial.
The Barrett’s Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS) showed that surveillance endoscopy did not significantly improve overall survival (OS) or cancer-specific survival, compared with “at-need” endoscopy requested by patients with symptoms, reported Oliver Old, MD, of Gloucestershire Hospitals NHS Foundation Trust, Gloucester, England, and colleagues.
“Surveillance endoscopy at regular intervals is advocated by major gastroenterology societies and practiced in numerous countries worldwide to detect esophageal adenocarcinoma (EAC) early in these high-risk patients,” investigators wrote in Gastroenterology. However, “there are conflicting observational studies on the benefits of Barrett’s esophagus surveillance.”
To address this knowledge gap, Old and colleagues conducted the first randomized study of its kind. The BOSS trial was a multicenter trial conducted at 109 hospitals across the United Kingdom. Adults with an endoscopic and histologic diagnosis of BE were eligible if they were fit for endoscopy and had no history of high-grade dysplasia, esophageal adenocarcinoma, or prior upper gastrointestinal cancer. Patients with low-grade dysplasia were permitted to enroll, consistent with practice guidelines at the time.
A total of 3,453 participants were randomized between 2009 and 2011 to undergo surveillance endoscopy every 2 years or to receive at-need endoscopy triggered only by symptoms. Patients and clinicians were aware of treatment assignment. In the surveillance group, quadrantic biopsies were taken at 2-cm intervals throughout the Barrett’s segment.
The primary endpoint was OS. Secondary outcomes included cancer-specific survival (deaths from any cancer), time to diagnosis of EAC, stage at diagnosis, number of endoscopies performed, and procedure-related adverse events.
Of the 3,453 patients randomized, 1,733 were assigned to surveillance and 1,719 to symptom-driven, at-need endoscopy. Baseline characteristics were similar between groups; the mean age was 63 years, and about 70% were men.
Over the course of the trial, 25% of patients in the surveillance arm, and 9% in the at-need arm, withdrew from the trial back into clinical care, but allowed data collection of their outcomes. After a median of 12.8 years of follow-up, there was no significant difference in overall survival: 333 deaths occurred in the surveillance group (19.2%) and 356 in the at-need group (20.7%; hazard ratio [HR], 0.95; 95% CI, 0.82-1.10). Cancer-specific survival was also similar across groups, with 108 cancer-related deaths in the surveillance arm and 106 in the at-need arm (HR, 1.01; 95% CI, 0.77-1.33).
EAC was diagnosed in 40 patients in the surveillance arm (2.3%) and 31 in the at-need arm (1.8%), a nonsignificant difference (HR, 1.32; 95% CI, 0.82-2.11). Stage at diagnosis did not differ between the two groups.
Endoscopy use was higher in the surveillance arm, with 6,124 procedures compared with 2,424 in the at-need arm. Serious adverse events were rare, reported in 0.5% of surveillance patients and 0.4% of at-need patients, with most related to complications of endoscopy such as bleeding or perforation.
End-of-trial exit endoscopy, offered only to patients in the at-need group (based on data and safety monitoring committee recommendation), detected an additional eight cases of EAC and eight cases of high-grade dysplasia, but these findings were not included in the primary trial analysis.
“These data challenge current clinical practice where surveillance is advocated for all patients with BE,” the investigators wrote. “These results are likely to influence societal guidelines regarding surveillance for nondysplastic BE and inform decision making for individual patients and clinicians.”
The study was supported by the Health Technology Assessment Programme, United Kingdom. The investigators disclosed no conflicts of interest.
Old et al report the results of a herculean effort to randomize patients with Barrett’s esophagus (BE) to either scheduled endoscopy at 2-year intervals or endoscopy “at need.” While the intent was to understand the protective effect of endoscopic surveillance, this goal was frustrated by the extensive use of endoscopy in the at-need arm. All told, 59% of at-need patients underwent endoscopy at a median of 25.7 month intervals (compared to the 24.8-month median interval in the surveillance group).
This degree of endoscopy use in at-need patients complicates interpretation, since, as the authors note, such contamination would likely bias the results to the null. Also, only 26% of randomized at-need patients took advantage of the study-end endoscopy. In this group, an additional eight cancers and nine high-grade dysplasia were noted, raising the specter that undiagnosed important disease was present in the at-need group.
Given these concerns, the BOSS results do not provide compelling evidence to change clinical practice. I continue to recommend endoscopic surveillance to my BE patients. However, the trial provides valuable insight. First, it prospectively confirms the low incidence of esophageal adenocarcinoma in low-risk BE, a rate of 0.23%/patient-year. Second, a lot of endoscopy is probably not better than some endoscopy in BE surveillance, and current trends seen in guidelines toward lengthening intervals in low-risk patients are likely merited. Finally, clinicians and patients may overestimate the utility of surveillance, and a patient-centered approach, acknowledging the uncertainties of the utility of endoscopy and the low risk of progression to cancer, is appropriate.
Nicholas J. Shaheen, MD, MPH, AGAF, is the Bozymski-Heizer Distinguished Professor of Medicine and senior associate dean for Clinical Research at the University of North Carolina School of Medicine, Chapel Hill, N.C. He has no conflicts to report.
Old et al report the results of a herculean effort to randomize patients with Barrett’s esophagus (BE) to either scheduled endoscopy at 2-year intervals or endoscopy “at need.” While the intent was to understand the protective effect of endoscopic surveillance, this goal was frustrated by the extensive use of endoscopy in the at-need arm. All told, 59% of at-need patients underwent endoscopy at a median of 25.7 month intervals (compared to the 24.8-month median interval in the surveillance group).
This degree of endoscopy use in at-need patients complicates interpretation, since, as the authors note, such contamination would likely bias the results to the null. Also, only 26% of randomized at-need patients took advantage of the study-end endoscopy. In this group, an additional eight cancers and nine high-grade dysplasia were noted, raising the specter that undiagnosed important disease was present in the at-need group.
Given these concerns, the BOSS results do not provide compelling evidence to change clinical practice. I continue to recommend endoscopic surveillance to my BE patients. However, the trial provides valuable insight. First, it prospectively confirms the low incidence of esophageal adenocarcinoma in low-risk BE, a rate of 0.23%/patient-year. Second, a lot of endoscopy is probably not better than some endoscopy in BE surveillance, and current trends seen in guidelines toward lengthening intervals in low-risk patients are likely merited. Finally, clinicians and patients may overestimate the utility of surveillance, and a patient-centered approach, acknowledging the uncertainties of the utility of endoscopy and the low risk of progression to cancer, is appropriate.
Nicholas J. Shaheen, MD, MPH, AGAF, is the Bozymski-Heizer Distinguished Professor of Medicine and senior associate dean for Clinical Research at the University of North Carolina School of Medicine, Chapel Hill, N.C. He has no conflicts to report.
Old et al report the results of a herculean effort to randomize patients with Barrett’s esophagus (BE) to either scheduled endoscopy at 2-year intervals or endoscopy “at need.” While the intent was to understand the protective effect of endoscopic surveillance, this goal was frustrated by the extensive use of endoscopy in the at-need arm. All told, 59% of at-need patients underwent endoscopy at a median of 25.7 month intervals (compared to the 24.8-month median interval in the surveillance group).
This degree of endoscopy use in at-need patients complicates interpretation, since, as the authors note, such contamination would likely bias the results to the null. Also, only 26% of randomized at-need patients took advantage of the study-end endoscopy. In this group, an additional eight cancers and nine high-grade dysplasia were noted, raising the specter that undiagnosed important disease was present in the at-need group.
Given these concerns, the BOSS results do not provide compelling evidence to change clinical practice. I continue to recommend endoscopic surveillance to my BE patients. However, the trial provides valuable insight. First, it prospectively confirms the low incidence of esophageal adenocarcinoma in low-risk BE, a rate of 0.23%/patient-year. Second, a lot of endoscopy is probably not better than some endoscopy in BE surveillance, and current trends seen in guidelines toward lengthening intervals in low-risk patients are likely merited. Finally, clinicians and patients may overestimate the utility of surveillance, and a patient-centered approach, acknowledging the uncertainties of the utility of endoscopy and the low risk of progression to cancer, is appropriate.
Nicholas J. Shaheen, MD, MPH, AGAF, is the Bozymski-Heizer Distinguished Professor of Medicine and senior associate dean for Clinical Research at the University of North Carolina School of Medicine, Chapel Hill, N.C. He has no conflicts to report.
based on results of a randomized controlled trial.
The Barrett’s Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS) showed that surveillance endoscopy did not significantly improve overall survival (OS) or cancer-specific survival, compared with “at-need” endoscopy requested by patients with symptoms, reported Oliver Old, MD, of Gloucestershire Hospitals NHS Foundation Trust, Gloucester, England, and colleagues.
“Surveillance endoscopy at regular intervals is advocated by major gastroenterology societies and practiced in numerous countries worldwide to detect esophageal adenocarcinoma (EAC) early in these high-risk patients,” investigators wrote in Gastroenterology. However, “there are conflicting observational studies on the benefits of Barrett’s esophagus surveillance.”
To address this knowledge gap, Old and colleagues conducted the first randomized study of its kind. The BOSS trial was a multicenter trial conducted at 109 hospitals across the United Kingdom. Adults with an endoscopic and histologic diagnosis of BE were eligible if they were fit for endoscopy and had no history of high-grade dysplasia, esophageal adenocarcinoma, or prior upper gastrointestinal cancer. Patients with low-grade dysplasia were permitted to enroll, consistent with practice guidelines at the time.
A total of 3,453 participants were randomized between 2009 and 2011 to undergo surveillance endoscopy every 2 years or to receive at-need endoscopy triggered only by symptoms. Patients and clinicians were aware of treatment assignment. In the surveillance group, quadrantic biopsies were taken at 2-cm intervals throughout the Barrett’s segment.
The primary endpoint was OS. Secondary outcomes included cancer-specific survival (deaths from any cancer), time to diagnosis of EAC, stage at diagnosis, number of endoscopies performed, and procedure-related adverse events.
Of the 3,453 patients randomized, 1,733 were assigned to surveillance and 1,719 to symptom-driven, at-need endoscopy. Baseline characteristics were similar between groups; the mean age was 63 years, and about 70% were men.
Over the course of the trial, 25% of patients in the surveillance arm, and 9% in the at-need arm, withdrew from the trial back into clinical care, but allowed data collection of their outcomes. After a median of 12.8 years of follow-up, there was no significant difference in overall survival: 333 deaths occurred in the surveillance group (19.2%) and 356 in the at-need group (20.7%; hazard ratio [HR], 0.95; 95% CI, 0.82-1.10). Cancer-specific survival was also similar across groups, with 108 cancer-related deaths in the surveillance arm and 106 in the at-need arm (HR, 1.01; 95% CI, 0.77-1.33).
EAC was diagnosed in 40 patients in the surveillance arm (2.3%) and 31 in the at-need arm (1.8%), a nonsignificant difference (HR, 1.32; 95% CI, 0.82-2.11). Stage at diagnosis did not differ between the two groups.
Endoscopy use was higher in the surveillance arm, with 6,124 procedures compared with 2,424 in the at-need arm. Serious adverse events were rare, reported in 0.5% of surveillance patients and 0.4% of at-need patients, with most related to complications of endoscopy such as bleeding or perforation.
End-of-trial exit endoscopy, offered only to patients in the at-need group (based on data and safety monitoring committee recommendation), detected an additional eight cases of EAC and eight cases of high-grade dysplasia, but these findings were not included in the primary trial analysis.
“These data challenge current clinical practice where surveillance is advocated for all patients with BE,” the investigators wrote. “These results are likely to influence societal guidelines regarding surveillance for nondysplastic BE and inform decision making for individual patients and clinicians.”
The study was supported by the Health Technology Assessment Programme, United Kingdom. The investigators disclosed no conflicts of interest.
based on results of a randomized controlled trial.
The Barrett’s Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS) showed that surveillance endoscopy did not significantly improve overall survival (OS) or cancer-specific survival, compared with “at-need” endoscopy requested by patients with symptoms, reported Oliver Old, MD, of Gloucestershire Hospitals NHS Foundation Trust, Gloucester, England, and colleagues.
“Surveillance endoscopy at regular intervals is advocated by major gastroenterology societies and practiced in numerous countries worldwide to detect esophageal adenocarcinoma (EAC) early in these high-risk patients,” investigators wrote in Gastroenterology. However, “there are conflicting observational studies on the benefits of Barrett’s esophagus surveillance.”
To address this knowledge gap, Old and colleagues conducted the first randomized study of its kind. The BOSS trial was a multicenter trial conducted at 109 hospitals across the United Kingdom. Adults with an endoscopic and histologic diagnosis of BE were eligible if they were fit for endoscopy and had no history of high-grade dysplasia, esophageal adenocarcinoma, or prior upper gastrointestinal cancer. Patients with low-grade dysplasia were permitted to enroll, consistent with practice guidelines at the time.
A total of 3,453 participants were randomized between 2009 and 2011 to undergo surveillance endoscopy every 2 years or to receive at-need endoscopy triggered only by symptoms. Patients and clinicians were aware of treatment assignment. In the surveillance group, quadrantic biopsies were taken at 2-cm intervals throughout the Barrett’s segment.
The primary endpoint was OS. Secondary outcomes included cancer-specific survival (deaths from any cancer), time to diagnosis of EAC, stage at diagnosis, number of endoscopies performed, and procedure-related adverse events.
Of the 3,453 patients randomized, 1,733 were assigned to surveillance and 1,719 to symptom-driven, at-need endoscopy. Baseline characteristics were similar between groups; the mean age was 63 years, and about 70% were men.
Over the course of the trial, 25% of patients in the surveillance arm, and 9% in the at-need arm, withdrew from the trial back into clinical care, but allowed data collection of their outcomes. After a median of 12.8 years of follow-up, there was no significant difference in overall survival: 333 deaths occurred in the surveillance group (19.2%) and 356 in the at-need group (20.7%; hazard ratio [HR], 0.95; 95% CI, 0.82-1.10). Cancer-specific survival was also similar across groups, with 108 cancer-related deaths in the surveillance arm and 106 in the at-need arm (HR, 1.01; 95% CI, 0.77-1.33).
EAC was diagnosed in 40 patients in the surveillance arm (2.3%) and 31 in the at-need arm (1.8%), a nonsignificant difference (HR, 1.32; 95% CI, 0.82-2.11). Stage at diagnosis did not differ between the two groups.
Endoscopy use was higher in the surveillance arm, with 6,124 procedures compared with 2,424 in the at-need arm. Serious adverse events were rare, reported in 0.5% of surveillance patients and 0.4% of at-need patients, with most related to complications of endoscopy such as bleeding or perforation.
End-of-trial exit endoscopy, offered only to patients in the at-need group (based on data and safety monitoring committee recommendation), detected an additional eight cases of EAC and eight cases of high-grade dysplasia, but these findings were not included in the primary trial analysis.
“These data challenge current clinical practice where surveillance is advocated for all patients with BE,” the investigators wrote. “These results are likely to influence societal guidelines regarding surveillance for nondysplastic BE and inform decision making for individual patients and clinicians.”
The study was supported by the Health Technology Assessment Programme, United Kingdom. The investigators disclosed no conflicts of interest.
FROM GASTROENTEROLOGY
MASLD/MASH Global Consensus Recommendations Address Guideline Discordance
These recommendations aim to boost guideline adherence and disease awareness, which have lagged despite a surge of national and international guidance in recent years, lead author Zobair M. Younossi, MD, of the Global NASH/MASH Council, Washington, DC, and colleagues, reported.
“Although these documents are similar in many ways, there are important differences in their recommendations, which have created some confusion within the field,” the panel wrote in Gastroenterology. “Areas of discordance among guidelines can be partly responsible for their low rate of implementation and the suboptimal awareness about this liver disease. Furthermore, these guidelines can be long and complex, making it challenging for busy clinicians to access the appropriate information quickly and efficiently.”
To address these gaps, more than 40 experts from around the world collaborated on the consensus project. The team reviewed 61 eligible documents published between 2018 and January 2025. Each guideline was evaluated across eight domains: epidemiology; screening; risk stratification using noninvasive tests (NITs); lifestyle management; treatment with existing medications; treatment with future medications; hepatocellular carcinoma (HCC) and preventive guidance; and pregnancy and pediatric populations.
Areas of discordance were advanced to a Delphi process using iterative online surveys, with a supermajority threshold of 67% required for acceptance. Four Delphi rounds were conducted, and by the end, all statements had achieved more than 90% agreement. The final recommendations were then summarized into practical algorithms for clinical use.
The results cover the full spectrum of MASLD care. For screening and diagnosis, experts agreed that individuals with type 2 diabetes, obesity plus cardiometabolic risk factors, or persistently elevated aminotransferases should be considered high risk. Alcohol thresholds were standardized, clarifying when to classify disease as MASLD, alcohol-related liver disease, or the hybrid “Met-ALD.”
For risk stratification, the panel endorsed a two-step algorithm beginning with the Fibrosis-4 (FIB-4) index, followed by vibration-controlled transient elastography (VCTE) or other NITs in patients above the threshold. This approach, the authors noted, was designed to be feasible in both primary care and specialty settings.
Lifestyle intervention remains the cornerstone of treatment, with weight-loss goals of 5% to reduce steatosis, 7%–10% to reduce inflammation, and at least 10% to improve fibrosis. To this end, the panel recommended a Mediterranean-style diet, increased physical activity, and reductions in sedentary time.
Drug therapy recommendations prioritized glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors for patients with diabetes or obesity, though these were not considered MASH-specific agents. Pioglitazone was noted as an option for diabetes management but not as direct MASH therapy. The panel did not recommend vitamin E, ursodeoxycholic acid, or omega-3 fatty acids, citing insufficient evidence.
The document also provides structured guidance on resmetirom, the first FDA-approved therapy for MASH. Its use was endorsed in patients with F2–F3 fibrosis confirmed by NITs, with safety checks at 3, 6, and 12 months, and efficacy evaluation after 1 year. Treatment futility was defined as concordant worsening across two NITs.
Preventive recommendations included hepatitis A and B vaccination and HCC surveillance every 6 months in patients with cirrhosis. Surveillance in noncirrhotic MASH was left to clinician judgment, based on individualized risk factors. Special considerations were outlined for pediatric and pregnant populations, although the evidence base in these groups remains sparse.
“Further research is required to determine the effectiveness of this algorithm in raising awareness of MASLD and its treatment,” Dr. Younossi and colleagues concluded.
The study was supported by the Global NASH/MASH Council, Inova Health System, and an unrestricted educational grant from Madrigal Pharmaceuticals. The investigators disclosed relationships with Sanofi, Gilead, AstraZeneca, and others.
The new consensus MASLD recommendations should help reconcile the “important differences” between guidelines from around the world, said Dr. Jaideep Behari, of the the University of Pittsburgh Medical Center.
Behari highlighted several points that may be underappreciated in clinical practice. “While many clinicians associate MASLD with obesity and type 2 diabetes, approximately a fifth of people living with MASLD are lean,” he said. “It may also come as a surprise to non-liver specialists that cardiovascular disease is the most common cause of mortality in patients with MASLD.”
He underscored the consensus recommendation to screen patients with type 2 diabetes, those with obesity and at least one cardiometabolic risk factor, and individuals with persistently elevated liver enzymes.
“Since many patients in the first two groups are mainly seen in primary care or endocrinology practices, physicians in these specialties need to be cognizant of these global consensus recommendations,” Behari said.
Turning to therapeutics, he described resmetirom as “a major milestone in the management of MASLD since it is the first drug approved in the US for treatment of MASH with F2 (moderate) or F3 (advanced) fibrosis.”
He noted that treatment requires careful patient selection and monitoring, including VCTE in the 8–20 kPa range, followed by serial liver injury testing. Efficacy should be assessed at 12 months, he noted, since “resmetirom was found to be effective in approximately a quarter of all treated patients in the pivotal clinical trial.”
“These limitations highlight the gaps in the treatment of MASLD/MASH and the need to continue development of other therapies,” Behari said.
Jaideep Behari, MD, PhD, AGAF, is director of the liver steatosis and metabolic wellness program at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. He reported research grant support from AstraZeneca, Madrigal, and recently completed research grant support from Gilead and Pfizer.
The new consensus MASLD recommendations should help reconcile the “important differences” between guidelines from around the world, said Dr. Jaideep Behari, of the the University of Pittsburgh Medical Center.
Behari highlighted several points that may be underappreciated in clinical practice. “While many clinicians associate MASLD with obesity and type 2 diabetes, approximately a fifth of people living with MASLD are lean,” he said. “It may also come as a surprise to non-liver specialists that cardiovascular disease is the most common cause of mortality in patients with MASLD.”
He underscored the consensus recommendation to screen patients with type 2 diabetes, those with obesity and at least one cardiometabolic risk factor, and individuals with persistently elevated liver enzymes.
“Since many patients in the first two groups are mainly seen in primary care or endocrinology practices, physicians in these specialties need to be cognizant of these global consensus recommendations,” Behari said.
Turning to therapeutics, he described resmetirom as “a major milestone in the management of MASLD since it is the first drug approved in the US for treatment of MASH with F2 (moderate) or F3 (advanced) fibrosis.”
He noted that treatment requires careful patient selection and monitoring, including VCTE in the 8–20 kPa range, followed by serial liver injury testing. Efficacy should be assessed at 12 months, he noted, since “resmetirom was found to be effective in approximately a quarter of all treated patients in the pivotal clinical trial.”
“These limitations highlight the gaps in the treatment of MASLD/MASH and the need to continue development of other therapies,” Behari said.
Jaideep Behari, MD, PhD, AGAF, is director of the liver steatosis and metabolic wellness program at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. He reported research grant support from AstraZeneca, Madrigal, and recently completed research grant support from Gilead and Pfizer.
The new consensus MASLD recommendations should help reconcile the “important differences” between guidelines from around the world, said Dr. Jaideep Behari, of the the University of Pittsburgh Medical Center.
Behari highlighted several points that may be underappreciated in clinical practice. “While many clinicians associate MASLD with obesity and type 2 diabetes, approximately a fifth of people living with MASLD are lean,” he said. “It may also come as a surprise to non-liver specialists that cardiovascular disease is the most common cause of mortality in patients with MASLD.”
He underscored the consensus recommendation to screen patients with type 2 diabetes, those with obesity and at least one cardiometabolic risk factor, and individuals with persistently elevated liver enzymes.
“Since many patients in the first two groups are mainly seen in primary care or endocrinology practices, physicians in these specialties need to be cognizant of these global consensus recommendations,” Behari said.
Turning to therapeutics, he described resmetirom as “a major milestone in the management of MASLD since it is the first drug approved in the US for treatment of MASH with F2 (moderate) or F3 (advanced) fibrosis.”
He noted that treatment requires careful patient selection and monitoring, including VCTE in the 8–20 kPa range, followed by serial liver injury testing. Efficacy should be assessed at 12 months, he noted, since “resmetirom was found to be effective in approximately a quarter of all treated patients in the pivotal clinical trial.”
“These limitations highlight the gaps in the treatment of MASLD/MASH and the need to continue development of other therapies,” Behari said.
Jaideep Behari, MD, PhD, AGAF, is director of the liver steatosis and metabolic wellness program at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. He reported research grant support from AstraZeneca, Madrigal, and recently completed research grant support from Gilead and Pfizer.
These recommendations aim to boost guideline adherence and disease awareness, which have lagged despite a surge of national and international guidance in recent years, lead author Zobair M. Younossi, MD, of the Global NASH/MASH Council, Washington, DC, and colleagues, reported.
“Although these documents are similar in many ways, there are important differences in their recommendations, which have created some confusion within the field,” the panel wrote in Gastroenterology. “Areas of discordance among guidelines can be partly responsible for their low rate of implementation and the suboptimal awareness about this liver disease. Furthermore, these guidelines can be long and complex, making it challenging for busy clinicians to access the appropriate information quickly and efficiently.”
To address these gaps, more than 40 experts from around the world collaborated on the consensus project. The team reviewed 61 eligible documents published between 2018 and January 2025. Each guideline was evaluated across eight domains: epidemiology; screening; risk stratification using noninvasive tests (NITs); lifestyle management; treatment with existing medications; treatment with future medications; hepatocellular carcinoma (HCC) and preventive guidance; and pregnancy and pediatric populations.
Areas of discordance were advanced to a Delphi process using iterative online surveys, with a supermajority threshold of 67% required for acceptance. Four Delphi rounds were conducted, and by the end, all statements had achieved more than 90% agreement. The final recommendations were then summarized into practical algorithms for clinical use.
The results cover the full spectrum of MASLD care. For screening and diagnosis, experts agreed that individuals with type 2 diabetes, obesity plus cardiometabolic risk factors, or persistently elevated aminotransferases should be considered high risk. Alcohol thresholds were standardized, clarifying when to classify disease as MASLD, alcohol-related liver disease, or the hybrid “Met-ALD.”
For risk stratification, the panel endorsed a two-step algorithm beginning with the Fibrosis-4 (FIB-4) index, followed by vibration-controlled transient elastography (VCTE) or other NITs in patients above the threshold. This approach, the authors noted, was designed to be feasible in both primary care and specialty settings.
Lifestyle intervention remains the cornerstone of treatment, with weight-loss goals of 5% to reduce steatosis, 7%–10% to reduce inflammation, and at least 10% to improve fibrosis. To this end, the panel recommended a Mediterranean-style diet, increased physical activity, and reductions in sedentary time.
Drug therapy recommendations prioritized glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors for patients with diabetes or obesity, though these were not considered MASH-specific agents. Pioglitazone was noted as an option for diabetes management but not as direct MASH therapy. The panel did not recommend vitamin E, ursodeoxycholic acid, or omega-3 fatty acids, citing insufficient evidence.
The document also provides structured guidance on resmetirom, the first FDA-approved therapy for MASH. Its use was endorsed in patients with F2–F3 fibrosis confirmed by NITs, with safety checks at 3, 6, and 12 months, and efficacy evaluation after 1 year. Treatment futility was defined as concordant worsening across two NITs.
Preventive recommendations included hepatitis A and B vaccination and HCC surveillance every 6 months in patients with cirrhosis. Surveillance in noncirrhotic MASH was left to clinician judgment, based on individualized risk factors. Special considerations were outlined for pediatric and pregnant populations, although the evidence base in these groups remains sparse.
“Further research is required to determine the effectiveness of this algorithm in raising awareness of MASLD and its treatment,” Dr. Younossi and colleagues concluded.
The study was supported by the Global NASH/MASH Council, Inova Health System, and an unrestricted educational grant from Madrigal Pharmaceuticals. The investigators disclosed relationships with Sanofi, Gilead, AstraZeneca, and others.
These recommendations aim to boost guideline adherence and disease awareness, which have lagged despite a surge of national and international guidance in recent years, lead author Zobair M. Younossi, MD, of the Global NASH/MASH Council, Washington, DC, and colleagues, reported.
“Although these documents are similar in many ways, there are important differences in their recommendations, which have created some confusion within the field,” the panel wrote in Gastroenterology. “Areas of discordance among guidelines can be partly responsible for their low rate of implementation and the suboptimal awareness about this liver disease. Furthermore, these guidelines can be long and complex, making it challenging for busy clinicians to access the appropriate information quickly and efficiently.”
To address these gaps, more than 40 experts from around the world collaborated on the consensus project. The team reviewed 61 eligible documents published between 2018 and January 2025. Each guideline was evaluated across eight domains: epidemiology; screening; risk stratification using noninvasive tests (NITs); lifestyle management; treatment with existing medications; treatment with future medications; hepatocellular carcinoma (HCC) and preventive guidance; and pregnancy and pediatric populations.
Areas of discordance were advanced to a Delphi process using iterative online surveys, with a supermajority threshold of 67% required for acceptance. Four Delphi rounds were conducted, and by the end, all statements had achieved more than 90% agreement. The final recommendations were then summarized into practical algorithms for clinical use.
The results cover the full spectrum of MASLD care. For screening and diagnosis, experts agreed that individuals with type 2 diabetes, obesity plus cardiometabolic risk factors, or persistently elevated aminotransferases should be considered high risk. Alcohol thresholds were standardized, clarifying when to classify disease as MASLD, alcohol-related liver disease, or the hybrid “Met-ALD.”
For risk stratification, the panel endorsed a two-step algorithm beginning with the Fibrosis-4 (FIB-4) index, followed by vibration-controlled transient elastography (VCTE) or other NITs in patients above the threshold. This approach, the authors noted, was designed to be feasible in both primary care and specialty settings.
Lifestyle intervention remains the cornerstone of treatment, with weight-loss goals of 5% to reduce steatosis, 7%–10% to reduce inflammation, and at least 10% to improve fibrosis. To this end, the panel recommended a Mediterranean-style diet, increased physical activity, and reductions in sedentary time.
Drug therapy recommendations prioritized glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors for patients with diabetes or obesity, though these were not considered MASH-specific agents. Pioglitazone was noted as an option for diabetes management but not as direct MASH therapy. The panel did not recommend vitamin E, ursodeoxycholic acid, or omega-3 fatty acids, citing insufficient evidence.
The document also provides structured guidance on resmetirom, the first FDA-approved therapy for MASH. Its use was endorsed in patients with F2–F3 fibrosis confirmed by NITs, with safety checks at 3, 6, and 12 months, and efficacy evaluation after 1 year. Treatment futility was defined as concordant worsening across two NITs.
Preventive recommendations included hepatitis A and B vaccination and HCC surveillance every 6 months in patients with cirrhosis. Surveillance in noncirrhotic MASH was left to clinician judgment, based on individualized risk factors. Special considerations were outlined for pediatric and pregnant populations, although the evidence base in these groups remains sparse.
“Further research is required to determine the effectiveness of this algorithm in raising awareness of MASLD and its treatment,” Dr. Younossi and colleagues concluded.
The study was supported by the Global NASH/MASH Council, Inova Health System, and an unrestricted educational grant from Madrigal Pharmaceuticals. The investigators disclosed relationships with Sanofi, Gilead, AstraZeneca, and others.
FROM GASTROENTEROLOGY
Long-Term Data Support Reduced-Dose Maintenance in EoE
, according to a recent meta-analysis of long-term data.
These findings support keeping patients on long-term maintenance therapy to prevent relapse, lead author Alberto Barchi, MD, of IRCCS Ospedale San Raffaele, Milan, Italy, and colleagues, reported.
“Given the high relapse rate after treatment cessation, despite good initial response after induction, there is need for further information about long-term outcomes of maintenance treatments,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, few studies have focused on long-term effects of EoE therapies.”
In response, Dr. Barchi and colleagues conducted the present systematic review and meta-analysis, which included studies evaluating maintenance therapies for EoE with at least 48 weeks of follow-up. Eligible studies enrolled patients with confirmed EoE who had received an induction regimen and continued therapy long-term. The final dataset comprised 9 randomized controlled trials (RCTs) and 11 observational studies, with long-term outcomes were reported among 1,819 patients.
The primary outcome was histologic success, defined as fewer than 15 or 6 eosinophils per high-power field (HPF). Secondary outcomes included clinical and endoscopic response, treatment adherence, and safety events.
Random-effects meta-analyses were performed, with randomized trials and observational studies analyzed separately. Risk ratios for sustained remission versus placebo or induction therapy were calculated, and heterogeneity was assessed using the I² statistic. Safety outcomes included pooled rates of adverse events, severe adverse events, and treatment discontinuation.
Across 9 randomized controlled trials, swallowed topical corticosteroids (STCs) maintained histologic remission (less than 15 eosinophils/HPF) in 86% of patients, while biologics achieved a rate of 79%. At the stricter threshold of less than 6 eosinophils/HPF, remission rates for STCs and biologics were 59% and 70%, respectively.
Clinical remission rates were lower, at 58% for STCs and 59% for biologics. Endoscopic outcomes were less consistent-ly reported, but most trials showed stable or improved scores during long-term treatment.
In observational cohorts, proton pump inhibitors (PPIs) maintained histologic remission in 64% of patients and clinical remission in 80%. For STCs in the real-world setting, histologic and clinical remission rates were 49% and 51%, respectively.
Stepping down the dose of maintenance therapy—whether conventional or biologic—did not increase relapse risk (RR 1.04; 95% CI, 0.72–1.51). In contrast, treatment withdrawal was clearly associated with higher relapse rates: in pooled analyses, continuing therapy yielded nearly an 8-fold greater likelihood of sustained remission compared with discontinuation (RR 7.87; 95% CI, 4.19–14.77).
Safety signals were favorable. Severe adverse events occurred in 3% of patients in randomized trials and 5% in observational studies, while overall withdrawal rates were 10% and 4%, respectively. The most common adverse events with STCs were oropharyngeal candidiasis and reductions in morning cortisol, while biologics were mainly associated with injection-site reactions, headache, and nasopharyngitis.
“Results suggest that prolonging treatment is efficient in maintaining histologic and clinical remission, with overall drug-related safe profiles both in randomized trials and observational studies,” the investigators concluded, noting that more work is needed to determine if there is an optimal drug for maintenance therapy, and if certain patients can successfully discontinue treatment.
The investigators disclosed relationships with Pfizer, UCB Pharma, AstraZeneca, and others.
, according to a recent meta-analysis of long-term data.
These findings support keeping patients on long-term maintenance therapy to prevent relapse, lead author Alberto Barchi, MD, of IRCCS Ospedale San Raffaele, Milan, Italy, and colleagues, reported.
“Given the high relapse rate after treatment cessation, despite good initial response after induction, there is need for further information about long-term outcomes of maintenance treatments,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, few studies have focused on long-term effects of EoE therapies.”
In response, Dr. Barchi and colleagues conducted the present systematic review and meta-analysis, which included studies evaluating maintenance therapies for EoE with at least 48 weeks of follow-up. Eligible studies enrolled patients with confirmed EoE who had received an induction regimen and continued therapy long-term. The final dataset comprised 9 randomized controlled trials (RCTs) and 11 observational studies, with long-term outcomes were reported among 1,819 patients.
The primary outcome was histologic success, defined as fewer than 15 or 6 eosinophils per high-power field (HPF). Secondary outcomes included clinical and endoscopic response, treatment adherence, and safety events.
Random-effects meta-analyses were performed, with randomized trials and observational studies analyzed separately. Risk ratios for sustained remission versus placebo or induction therapy were calculated, and heterogeneity was assessed using the I² statistic. Safety outcomes included pooled rates of adverse events, severe adverse events, and treatment discontinuation.
Across 9 randomized controlled trials, swallowed topical corticosteroids (STCs) maintained histologic remission (less than 15 eosinophils/HPF) in 86% of patients, while biologics achieved a rate of 79%. At the stricter threshold of less than 6 eosinophils/HPF, remission rates for STCs and biologics were 59% and 70%, respectively.
Clinical remission rates were lower, at 58% for STCs and 59% for biologics. Endoscopic outcomes were less consistent-ly reported, but most trials showed stable or improved scores during long-term treatment.
In observational cohorts, proton pump inhibitors (PPIs) maintained histologic remission in 64% of patients and clinical remission in 80%. For STCs in the real-world setting, histologic and clinical remission rates were 49% and 51%, respectively.
Stepping down the dose of maintenance therapy—whether conventional or biologic—did not increase relapse risk (RR 1.04; 95% CI, 0.72–1.51). In contrast, treatment withdrawal was clearly associated with higher relapse rates: in pooled analyses, continuing therapy yielded nearly an 8-fold greater likelihood of sustained remission compared with discontinuation (RR 7.87; 95% CI, 4.19–14.77).
Safety signals were favorable. Severe adverse events occurred in 3% of patients in randomized trials and 5% in observational studies, while overall withdrawal rates were 10% and 4%, respectively. The most common adverse events with STCs were oropharyngeal candidiasis and reductions in morning cortisol, while biologics were mainly associated with injection-site reactions, headache, and nasopharyngitis.
“Results suggest that prolonging treatment is efficient in maintaining histologic and clinical remission, with overall drug-related safe profiles both in randomized trials and observational studies,” the investigators concluded, noting that more work is needed to determine if there is an optimal drug for maintenance therapy, and if certain patients can successfully discontinue treatment.
The investigators disclosed relationships with Pfizer, UCB Pharma, AstraZeneca, and others.
, according to a recent meta-analysis of long-term data.
These findings support keeping patients on long-term maintenance therapy to prevent relapse, lead author Alberto Barchi, MD, of IRCCS Ospedale San Raffaele, Milan, Italy, and colleagues, reported.
“Given the high relapse rate after treatment cessation, despite good initial response after induction, there is need for further information about long-term outcomes of maintenance treatments,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, few studies have focused on long-term effects of EoE therapies.”
In response, Dr. Barchi and colleagues conducted the present systematic review and meta-analysis, which included studies evaluating maintenance therapies for EoE with at least 48 weeks of follow-up. Eligible studies enrolled patients with confirmed EoE who had received an induction regimen and continued therapy long-term. The final dataset comprised 9 randomized controlled trials (RCTs) and 11 observational studies, with long-term outcomes were reported among 1,819 patients.
The primary outcome was histologic success, defined as fewer than 15 or 6 eosinophils per high-power field (HPF). Secondary outcomes included clinical and endoscopic response, treatment adherence, and safety events.
Random-effects meta-analyses were performed, with randomized trials and observational studies analyzed separately. Risk ratios for sustained remission versus placebo or induction therapy were calculated, and heterogeneity was assessed using the I² statistic. Safety outcomes included pooled rates of adverse events, severe adverse events, and treatment discontinuation.
Across 9 randomized controlled trials, swallowed topical corticosteroids (STCs) maintained histologic remission (less than 15 eosinophils/HPF) in 86% of patients, while biologics achieved a rate of 79%. At the stricter threshold of less than 6 eosinophils/HPF, remission rates for STCs and biologics were 59% and 70%, respectively.
Clinical remission rates were lower, at 58% for STCs and 59% for biologics. Endoscopic outcomes were less consistent-ly reported, but most trials showed stable or improved scores during long-term treatment.
In observational cohorts, proton pump inhibitors (PPIs) maintained histologic remission in 64% of patients and clinical remission in 80%. For STCs in the real-world setting, histologic and clinical remission rates were 49% and 51%, respectively.
Stepping down the dose of maintenance therapy—whether conventional or biologic—did not increase relapse risk (RR 1.04; 95% CI, 0.72–1.51). In contrast, treatment withdrawal was clearly associated with higher relapse rates: in pooled analyses, continuing therapy yielded nearly an 8-fold greater likelihood of sustained remission compared with discontinuation (RR 7.87; 95% CI, 4.19–14.77).
Safety signals were favorable. Severe adverse events occurred in 3% of patients in randomized trials and 5% in observational studies, while overall withdrawal rates were 10% and 4%, respectively. The most common adverse events with STCs were oropharyngeal candidiasis and reductions in morning cortisol, while biologics were mainly associated with injection-site reactions, headache, and nasopharyngitis.
“Results suggest that prolonging treatment is efficient in maintaining histologic and clinical remission, with overall drug-related safe profiles both in randomized trials and observational studies,” the investigators concluded, noting that more work is needed to determine if there is an optimal drug for maintenance therapy, and if certain patients can successfully discontinue treatment.
The investigators disclosed relationships with Pfizer, UCB Pharma, AstraZeneca, and others.
FROM GASTROENTEROLOGY
Simpler Approach Increases Diagnostic Accuracy of Timed Barium Esophagram for Achalasia
, according to investigators.
The classification tree offers a practical alternative for evaluating esophagogastric junction (EGJ) outflow disorders when more advanced methods like high-resolution manometry (HRM) or functional lumen imaging probe (FLIP) panometry are unavailable, lead author Ofer Z. Fass, MD, of Northwestern University, Chicago, and colleagues reported.
“[T]here are limited data on normative TBE values,” the investigators wrote in Gastroenterology. “Furthermore, data supporting the accuracy of TBE as a screening test for esophageal motility disorders, as well as clinically relevant test thresholds, remains limited.”
TBE is conventionally interpreted using a handful of single measurements, most often the barium column height at 1, 2, or 5 minutes. Although these metrics are simple to obtain, variability in technique, cutoff values, and interpretation across centers limits reproducibility and weakens diagnostic accuracy, according to the investigators. The role of TBE has therefore been largely confined to adjudicating inconclusive manometry findings, but even in that setting, the absence of validated reference standards constrains its utility as a reliable screening tool.
To address this gap, Fass and colleagues conducted a prospective analysis of 290 patients who underwent TBE at Northwestern Memorial Hospital, Chicago, with HRM and FLIP panometry, interpreted according to the Chicago Classification version 4.0 (CCv4.0), serving as the diagnostic reference standards.
Patients were included if they had both TBE and manometry performed within a short interval, ensuring that the two tests could be meaningfully compared. The study population represented a broad spectrum of esophageal motility presentations, allowing the model to be trained on clinically relevant variation.
Beyond column height, the investigators measured barium height at multiple timepoints, maximal esophageal body width, maximum EGJ diameter, and tablet passage. These variables were incorporated into a recursive partitioning algorithm to build a multimetric classification tree aimed at distinguishing EGJ outflow obstruction from other motility disorders.
The optimal tree incorporated three sequential decision levels. At the top was maximum esophageal body width, followed by EGJ diameter and barium height at the second level, and tablet passage at the third. This stepwise structure allowed the model to refine diagnoses by combining simple, reproducible TBE metrics that are already collected in routine practice.
Among the 290 patients, 121 (42%) had EGJ outflow disorders, 151 (52%) had no outflow disorder, and 18 (6%) had inconclusive manometry findings. Using conventional interpretation with column height and tablet passage, TBE demonstrated a sensitivity of 77.8%, a specificity of 86.0%, and an accuracy of 82.2%. The multimetric classification tree improved diagnostic performance across all parameters, with a sensitivity of 84.2%, a specificity of 92.1%, and an accuracy of 88.3%.
The advantages of multimetric interpretation were most notable in patients with borderline column heights, which single-metric approaches often misclassify, underscoring the value of integrating multiple measurements into a unified model.
“[T]his study demonstrated that TBE can accurately identify achalasia when analyzed using multiple metrics in a classification tree model,” Fass and colleagues wrote. “Future studies should explore the use of TBE metrics and models to identify more specific esophageal motor disorders (such as esophageal spasm and absent contractility), as well as validation in a larger, multicenter cohort.”
Clinical Takeaways
Rishi Naik, MD, of the Center for Swallowing and Esophageal Disorders, Vanderbilt University Medical Center, Nashville, Tennessee, said the study represents a step forward in how clinicians can use a widely accessible esophageal imaging test.
“This study is important in that it has updated the way we use a very common, readily available imaging test and compared it to the current gold standard of HRM and FLIP,” he told GI & Hepatology News. “This provides a practical, standardized framework for clinicians evaluating patients with suspected esophageal motility disorders.”
Naik noted that while HRM and FLIP provide highly detailed information, both carry drawbacks that limit their universal adoption.
“Practically, HRM is a transnasal test that can be cumbersome, and FLIP is performed during a sedated procedure,” he said. “From a comfort and cost perspective, the esophagram outcompetes. What the TBE lacked was adequate sensitivity and specificity when just looking at column height, which is how the authors overcame this by leveraging the comparisons using CCv4.0.”
Implementation, however, requires discipline.
“A timed barium esophagram is a protocol, not a single esophagram,” Naik said. “Without proper measurements, you can’t follow the decision tree.”
Still, he pointed to radiology’s increasing adoption of artificial intelligence (AI) as a promising way forward.
“AI has already transformed radiological reads, and I’m optimistic it will eventually allow us to incorporate not only width, height, and tablet clearance but also 3D [three-dimensional] reconstructions of bolus retention and pressure to enhance predictive modeling,” Naik said.
This study was supported by the Public Health Service.
The investigators disclosed having relationships with Takeda, Phathom Pharmaceuticals, Medtronic, and others. Naik is a consultant for Sanofi/Regeneron, Eli Lilly and Company, and Renexxion.
A version of this article appeared on Medscape.com.
, according to investigators.
The classification tree offers a practical alternative for evaluating esophagogastric junction (EGJ) outflow disorders when more advanced methods like high-resolution manometry (HRM) or functional lumen imaging probe (FLIP) panometry are unavailable, lead author Ofer Z. Fass, MD, of Northwestern University, Chicago, and colleagues reported.
“[T]here are limited data on normative TBE values,” the investigators wrote in Gastroenterology. “Furthermore, data supporting the accuracy of TBE as a screening test for esophageal motility disorders, as well as clinically relevant test thresholds, remains limited.”
TBE is conventionally interpreted using a handful of single measurements, most often the barium column height at 1, 2, or 5 minutes. Although these metrics are simple to obtain, variability in technique, cutoff values, and interpretation across centers limits reproducibility and weakens diagnostic accuracy, according to the investigators. The role of TBE has therefore been largely confined to adjudicating inconclusive manometry findings, but even in that setting, the absence of validated reference standards constrains its utility as a reliable screening tool.
To address this gap, Fass and colleagues conducted a prospective analysis of 290 patients who underwent TBE at Northwestern Memorial Hospital, Chicago, with HRM and FLIP panometry, interpreted according to the Chicago Classification version 4.0 (CCv4.0), serving as the diagnostic reference standards.
Patients were included if they had both TBE and manometry performed within a short interval, ensuring that the two tests could be meaningfully compared. The study population represented a broad spectrum of esophageal motility presentations, allowing the model to be trained on clinically relevant variation.
Beyond column height, the investigators measured barium height at multiple timepoints, maximal esophageal body width, maximum EGJ diameter, and tablet passage. These variables were incorporated into a recursive partitioning algorithm to build a multimetric classification tree aimed at distinguishing EGJ outflow obstruction from other motility disorders.
The optimal tree incorporated three sequential decision levels. At the top was maximum esophageal body width, followed by EGJ diameter and barium height at the second level, and tablet passage at the third. This stepwise structure allowed the model to refine diagnoses by combining simple, reproducible TBE metrics that are already collected in routine practice.
Among the 290 patients, 121 (42%) had EGJ outflow disorders, 151 (52%) had no outflow disorder, and 18 (6%) had inconclusive manometry findings. Using conventional interpretation with column height and tablet passage, TBE demonstrated a sensitivity of 77.8%, a specificity of 86.0%, and an accuracy of 82.2%. The multimetric classification tree improved diagnostic performance across all parameters, with a sensitivity of 84.2%, a specificity of 92.1%, and an accuracy of 88.3%.
The advantages of multimetric interpretation were most notable in patients with borderline column heights, which single-metric approaches often misclassify, underscoring the value of integrating multiple measurements into a unified model.
“[T]his study demonstrated that TBE can accurately identify achalasia when analyzed using multiple metrics in a classification tree model,” Fass and colleagues wrote. “Future studies should explore the use of TBE metrics and models to identify more specific esophageal motor disorders (such as esophageal spasm and absent contractility), as well as validation in a larger, multicenter cohort.”
Clinical Takeaways
Rishi Naik, MD, of the Center for Swallowing and Esophageal Disorders, Vanderbilt University Medical Center, Nashville, Tennessee, said the study represents a step forward in how clinicians can use a widely accessible esophageal imaging test.
“This study is important in that it has updated the way we use a very common, readily available imaging test and compared it to the current gold standard of HRM and FLIP,” he told GI & Hepatology News. “This provides a practical, standardized framework for clinicians evaluating patients with suspected esophageal motility disorders.”
Naik noted that while HRM and FLIP provide highly detailed information, both carry drawbacks that limit their universal adoption.
“Practically, HRM is a transnasal test that can be cumbersome, and FLIP is performed during a sedated procedure,” he said. “From a comfort and cost perspective, the esophagram outcompetes. What the TBE lacked was adequate sensitivity and specificity when just looking at column height, which is how the authors overcame this by leveraging the comparisons using CCv4.0.”
Implementation, however, requires discipline.
“A timed barium esophagram is a protocol, not a single esophagram,” Naik said. “Without proper measurements, you can’t follow the decision tree.”
Still, he pointed to radiology’s increasing adoption of artificial intelligence (AI) as a promising way forward.
“AI has already transformed radiological reads, and I’m optimistic it will eventually allow us to incorporate not only width, height, and tablet clearance but also 3D [three-dimensional] reconstructions of bolus retention and pressure to enhance predictive modeling,” Naik said.
This study was supported by the Public Health Service.
The investigators disclosed having relationships with Takeda, Phathom Pharmaceuticals, Medtronic, and others. Naik is a consultant for Sanofi/Regeneron, Eli Lilly and Company, and Renexxion.
A version of this article appeared on Medscape.com.
, according to investigators.
The classification tree offers a practical alternative for evaluating esophagogastric junction (EGJ) outflow disorders when more advanced methods like high-resolution manometry (HRM) or functional lumen imaging probe (FLIP) panometry are unavailable, lead author Ofer Z. Fass, MD, of Northwestern University, Chicago, and colleagues reported.
“[T]here are limited data on normative TBE values,” the investigators wrote in Gastroenterology. “Furthermore, data supporting the accuracy of TBE as a screening test for esophageal motility disorders, as well as clinically relevant test thresholds, remains limited.”
TBE is conventionally interpreted using a handful of single measurements, most often the barium column height at 1, 2, or 5 minutes. Although these metrics are simple to obtain, variability in technique, cutoff values, and interpretation across centers limits reproducibility and weakens diagnostic accuracy, according to the investigators. The role of TBE has therefore been largely confined to adjudicating inconclusive manometry findings, but even in that setting, the absence of validated reference standards constrains its utility as a reliable screening tool.
To address this gap, Fass and colleagues conducted a prospective analysis of 290 patients who underwent TBE at Northwestern Memorial Hospital, Chicago, with HRM and FLIP panometry, interpreted according to the Chicago Classification version 4.0 (CCv4.0), serving as the diagnostic reference standards.
Patients were included if they had both TBE and manometry performed within a short interval, ensuring that the two tests could be meaningfully compared. The study population represented a broad spectrum of esophageal motility presentations, allowing the model to be trained on clinically relevant variation.
Beyond column height, the investigators measured barium height at multiple timepoints, maximal esophageal body width, maximum EGJ diameter, and tablet passage. These variables were incorporated into a recursive partitioning algorithm to build a multimetric classification tree aimed at distinguishing EGJ outflow obstruction from other motility disorders.
The optimal tree incorporated three sequential decision levels. At the top was maximum esophageal body width, followed by EGJ diameter and barium height at the second level, and tablet passage at the third. This stepwise structure allowed the model to refine diagnoses by combining simple, reproducible TBE metrics that are already collected in routine practice.
Among the 290 patients, 121 (42%) had EGJ outflow disorders, 151 (52%) had no outflow disorder, and 18 (6%) had inconclusive manometry findings. Using conventional interpretation with column height and tablet passage, TBE demonstrated a sensitivity of 77.8%, a specificity of 86.0%, and an accuracy of 82.2%. The multimetric classification tree improved diagnostic performance across all parameters, with a sensitivity of 84.2%, a specificity of 92.1%, and an accuracy of 88.3%.
The advantages of multimetric interpretation were most notable in patients with borderline column heights, which single-metric approaches often misclassify, underscoring the value of integrating multiple measurements into a unified model.
“[T]his study demonstrated that TBE can accurately identify achalasia when analyzed using multiple metrics in a classification tree model,” Fass and colleagues wrote. “Future studies should explore the use of TBE metrics and models to identify more specific esophageal motor disorders (such as esophageal spasm and absent contractility), as well as validation in a larger, multicenter cohort.”
Clinical Takeaways
Rishi Naik, MD, of the Center for Swallowing and Esophageal Disorders, Vanderbilt University Medical Center, Nashville, Tennessee, said the study represents a step forward in how clinicians can use a widely accessible esophageal imaging test.
“This study is important in that it has updated the way we use a very common, readily available imaging test and compared it to the current gold standard of HRM and FLIP,” he told GI & Hepatology News. “This provides a practical, standardized framework for clinicians evaluating patients with suspected esophageal motility disorders.”
Naik noted that while HRM and FLIP provide highly detailed information, both carry drawbacks that limit their universal adoption.
“Practically, HRM is a transnasal test that can be cumbersome, and FLIP is performed during a sedated procedure,” he said. “From a comfort and cost perspective, the esophagram outcompetes. What the TBE lacked was adequate sensitivity and specificity when just looking at column height, which is how the authors overcame this by leveraging the comparisons using CCv4.0.”
Implementation, however, requires discipline.
“A timed barium esophagram is a protocol, not a single esophagram,” Naik said. “Without proper measurements, you can’t follow the decision tree.”
Still, he pointed to radiology’s increasing adoption of artificial intelligence (AI) as a promising way forward.
“AI has already transformed radiological reads, and I’m optimistic it will eventually allow us to incorporate not only width, height, and tablet clearance but also 3D [three-dimensional] reconstructions of bolus retention and pressure to enhance predictive modeling,” Naik said.
This study was supported by the Public Health Service.
The investigators disclosed having relationships with Takeda, Phathom Pharmaceuticals, Medtronic, and others. Naik is a consultant for Sanofi/Regeneron, Eli Lilly and Company, and Renexxion.
A version of this article appeared on Medscape.com.
FROM GASTROENTEROLOGY
GLP-1s Increase GERD Risk Over SGLT2 Inhibitors in T2D
in a cohort study of new users.
Risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and patients with gastric comorbidities.
“The findings were not entirely surprising,” principal author Laurent Azoulay, PhD, of McGill University and Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada, told GI & Hepatology News. “There is a plausible biological mechanism through which GLP-1 RAs could increase the risk of GERD — namely, by delaying gastric emptying, which can lead to symptoms of reflux. Still, it’s always valuable to see whether the clinical data support what we suspect from a physiological standpoint.”
“As with any medication, it’s about balancing benefits and risks — and being proactive when side effects emerge,” he added.
The study was published online in Annals of Internal Medicine.
Duration of Use, Drug Action
Researchers designed an active comparator new-user cohort study emulating a target trial to estimate the effects of GLP-1 RAs compared with SGLT2 inhibitors on the risk for GERD and its complications among patients with T2D.
The study included 24,708 new users of GLP-1 RAs and 89,096 new users of SGLT2 inhibitors. Participants had a mean age of 56 years, and 55% were men. They initiated treatment with the drugs from January 2013 through December 2021, with follow-up through March 2022.
Three-year risk differences (RDs) and risk ratios (RRs) were estimated and weighted using propensity score fine stratification.
Overall, during follow-up, the incidence rate of GERD was 7.9 per 1000 person-years; 138 complications of GERD were observed, with over 90% of them being Barrett’s esophagus.
Over a median follow-up of 3 years, among GLP-1 RA users compared with SGLT2 inhibitor users, the RRs were 1.27 for GERD, with an RD of 0.7 per 100 patients, and 1.55 for complications, with an RD of 0.8 per 1000 patients.
Further analyses found that risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and those with gastric comorbidities associated with gastric motility. The findings remained robust across sensitivity analyses addressing various types of biases.
The widening incidence curves with duration of use may indicate that mucosal injury and symptom severity correlate with reflux frequency and duration of esophageal acid exposure, the authors suggested.
GERD risk also was higher with long-acting GLP-1 RA use, suggesting that long-acting GLP-1 RAs (liraglutide, exenatide once weekly, dulaglutide, and semaglutide) may have more sustained delaying effects, they noted.
“These potential risks should be weighed against the established clinical benefits of this drug class, particularly in patients at high risk for gastroparesis and GERD,” the authors concluded.
“Given the mechanism through which these drugs may cause GERD, we can reasonably speculate that a similar effect might be observed in individuals without diabetes,” Azoulay added. “That said, a dedicated study would be needed to confirm that.”
Close Monitoring Advised
Caroline Collins, MD, assistant professor at Emory University School of Medicine in Atlanta, agreed with the findings and said the association between GLP-1s and GERD is consistent with what she has observed in her practice.
“I routinely counsel patients about the potential for GERD symptoms as well as other side effects before initiating GLP-1 therapy,” she told GI & Hepatology News. “Several patients on GLP-1s have reported new or worsening reflux symptoms after initiating therapy. Sometimes, we can lower the dose, and the GERD resolves. Other times initiating GERD treatment or discontinuing the medication is appropriate.”
“Patients with T2D are already at increased risk for delayed gastric emptying, which in itself is a contributor to GERD,” said Collins, who was not involved in the study. “Therefore, adding a GLP-1 RA, which further slows gastric motility, may compound this risk. I consider this when assessing which patients are the best candidates for these medications and often monitor more closely in patients with long-standing diabetes and other predisposing factors to GERD.”
Barrett’s esophagus and esophageal cancer generally occur over many years, she noted. “A median follow-up of 3 years may be insufficient to fully assess the long-term risks of serious complications.”
“Chronic cough, a common but often overlooked manifestation of GERD, was not included in the outcome definitions,” she added. Including chronic cough “may have captured a broader picture of reflux-related symptoms.”
The study was funded by a Foundation Scheme grant from the Canadian Institutes of Health Research. Azoulay holds a Distinguished Research Scholar award from the Fonds de recherche du Quebec – Sante and is the recipient of a William Dawson Scholar award from McGill University.
A version of this article appeared on Medscape.com.
in a cohort study of new users.
Risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and patients with gastric comorbidities.
“The findings were not entirely surprising,” principal author Laurent Azoulay, PhD, of McGill University and Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada, told GI & Hepatology News. “There is a plausible biological mechanism through which GLP-1 RAs could increase the risk of GERD — namely, by delaying gastric emptying, which can lead to symptoms of reflux. Still, it’s always valuable to see whether the clinical data support what we suspect from a physiological standpoint.”
“As with any medication, it’s about balancing benefits and risks — and being proactive when side effects emerge,” he added.
The study was published online in Annals of Internal Medicine.
Duration of Use, Drug Action
Researchers designed an active comparator new-user cohort study emulating a target trial to estimate the effects of GLP-1 RAs compared with SGLT2 inhibitors on the risk for GERD and its complications among patients with T2D.
The study included 24,708 new users of GLP-1 RAs and 89,096 new users of SGLT2 inhibitors. Participants had a mean age of 56 years, and 55% were men. They initiated treatment with the drugs from January 2013 through December 2021, with follow-up through March 2022.
Three-year risk differences (RDs) and risk ratios (RRs) were estimated and weighted using propensity score fine stratification.
Overall, during follow-up, the incidence rate of GERD was 7.9 per 1000 person-years; 138 complications of GERD were observed, with over 90% of them being Barrett’s esophagus.
Over a median follow-up of 3 years, among GLP-1 RA users compared with SGLT2 inhibitor users, the RRs were 1.27 for GERD, with an RD of 0.7 per 100 patients, and 1.55 for complications, with an RD of 0.8 per 1000 patients.
Further analyses found that risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and those with gastric comorbidities associated with gastric motility. The findings remained robust across sensitivity analyses addressing various types of biases.
The widening incidence curves with duration of use may indicate that mucosal injury and symptom severity correlate with reflux frequency and duration of esophageal acid exposure, the authors suggested.
GERD risk also was higher with long-acting GLP-1 RA use, suggesting that long-acting GLP-1 RAs (liraglutide, exenatide once weekly, dulaglutide, and semaglutide) may have more sustained delaying effects, they noted.
“These potential risks should be weighed against the established clinical benefits of this drug class, particularly in patients at high risk for gastroparesis and GERD,” the authors concluded.
“Given the mechanism through which these drugs may cause GERD, we can reasonably speculate that a similar effect might be observed in individuals without diabetes,” Azoulay added. “That said, a dedicated study would be needed to confirm that.”
Close Monitoring Advised
Caroline Collins, MD, assistant professor at Emory University School of Medicine in Atlanta, agreed with the findings and said the association between GLP-1s and GERD is consistent with what she has observed in her practice.
“I routinely counsel patients about the potential for GERD symptoms as well as other side effects before initiating GLP-1 therapy,” she told GI & Hepatology News. “Several patients on GLP-1s have reported new or worsening reflux symptoms after initiating therapy. Sometimes, we can lower the dose, and the GERD resolves. Other times initiating GERD treatment or discontinuing the medication is appropriate.”
“Patients with T2D are already at increased risk for delayed gastric emptying, which in itself is a contributor to GERD,” said Collins, who was not involved in the study. “Therefore, adding a GLP-1 RA, which further slows gastric motility, may compound this risk. I consider this when assessing which patients are the best candidates for these medications and often monitor more closely in patients with long-standing diabetes and other predisposing factors to GERD.”
Barrett’s esophagus and esophageal cancer generally occur over many years, she noted. “A median follow-up of 3 years may be insufficient to fully assess the long-term risks of serious complications.”
“Chronic cough, a common but often overlooked manifestation of GERD, was not included in the outcome definitions,” she added. Including chronic cough “may have captured a broader picture of reflux-related symptoms.”
The study was funded by a Foundation Scheme grant from the Canadian Institutes of Health Research. Azoulay holds a Distinguished Research Scholar award from the Fonds de recherche du Quebec – Sante and is the recipient of a William Dawson Scholar award from McGill University.
A version of this article appeared on Medscape.com.
in a cohort study of new users.
Risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and patients with gastric comorbidities.
“The findings were not entirely surprising,” principal author Laurent Azoulay, PhD, of McGill University and Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada, told GI & Hepatology News. “There is a plausible biological mechanism through which GLP-1 RAs could increase the risk of GERD — namely, by delaying gastric emptying, which can lead to symptoms of reflux. Still, it’s always valuable to see whether the clinical data support what we suspect from a physiological standpoint.”
“As with any medication, it’s about balancing benefits and risks — and being proactive when side effects emerge,” he added.
The study was published online in Annals of Internal Medicine.
Duration of Use, Drug Action
Researchers designed an active comparator new-user cohort study emulating a target trial to estimate the effects of GLP-1 RAs compared with SGLT2 inhibitors on the risk for GERD and its complications among patients with T2D.
The study included 24,708 new users of GLP-1 RAs and 89,096 new users of SGLT2 inhibitors. Participants had a mean age of 56 years, and 55% were men. They initiated treatment with the drugs from January 2013 through December 2021, with follow-up through March 2022.
Three-year risk differences (RDs) and risk ratios (RRs) were estimated and weighted using propensity score fine stratification.
Overall, during follow-up, the incidence rate of GERD was 7.9 per 1000 person-years; 138 complications of GERD were observed, with over 90% of them being Barrett’s esophagus.
Over a median follow-up of 3 years, among GLP-1 RA users compared with SGLT2 inhibitor users, the RRs were 1.27 for GERD, with an RD of 0.7 per 100 patients, and 1.55 for complications, with an RD of 0.8 per 1000 patients.
Further analyses found that risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and those with gastric comorbidities associated with gastric motility. The findings remained robust across sensitivity analyses addressing various types of biases.
The widening incidence curves with duration of use may indicate that mucosal injury and symptom severity correlate with reflux frequency and duration of esophageal acid exposure, the authors suggested.
GERD risk also was higher with long-acting GLP-1 RA use, suggesting that long-acting GLP-1 RAs (liraglutide, exenatide once weekly, dulaglutide, and semaglutide) may have more sustained delaying effects, they noted.
“These potential risks should be weighed against the established clinical benefits of this drug class, particularly in patients at high risk for gastroparesis and GERD,” the authors concluded.
“Given the mechanism through which these drugs may cause GERD, we can reasonably speculate that a similar effect might be observed in individuals without diabetes,” Azoulay added. “That said, a dedicated study would be needed to confirm that.”
Close Monitoring Advised
Caroline Collins, MD, assistant professor at Emory University School of Medicine in Atlanta, agreed with the findings and said the association between GLP-1s and GERD is consistent with what she has observed in her practice.
“I routinely counsel patients about the potential for GERD symptoms as well as other side effects before initiating GLP-1 therapy,” she told GI & Hepatology News. “Several patients on GLP-1s have reported new or worsening reflux symptoms after initiating therapy. Sometimes, we can lower the dose, and the GERD resolves. Other times initiating GERD treatment or discontinuing the medication is appropriate.”
“Patients with T2D are already at increased risk for delayed gastric emptying, which in itself is a contributor to GERD,” said Collins, who was not involved in the study. “Therefore, adding a GLP-1 RA, which further slows gastric motility, may compound this risk. I consider this when assessing which patients are the best candidates for these medications and often monitor more closely in patients with long-standing diabetes and other predisposing factors to GERD.”
Barrett’s esophagus and esophageal cancer generally occur over many years, she noted. “A median follow-up of 3 years may be insufficient to fully assess the long-term risks of serious complications.”
“Chronic cough, a common but often overlooked manifestation of GERD, was not included in the outcome definitions,” she added. Including chronic cough “may have captured a broader picture of reflux-related symptoms.”
The study was funded by a Foundation Scheme grant from the Canadian Institutes of Health Research. Azoulay holds a Distinguished Research Scholar award from the Fonds de recherche du Quebec – Sante and is the recipient of a William Dawson Scholar award from McGill University.
A version of this article appeared on Medscape.com.
Medicolegal Concerns in Contemporary Private GI Practice
The need for gastroenterology (GI) services is on the rise in the US, with growing rates of colonoscopy, earlier-onset colon cancer, and inflammatory bowel disease. This increase is taking place in the context of a changing regulatory landscape.
, and to that end, a recent educational practice management update was published in Clinical Gastroenterology and Hepatology by Erin Smith Aebel, JD, a health law specialist with Trenam Law in Tampa, Florida. Aebel has been a speaker at several national GI conferences and has addressed GI trainees on these issues in medical schools.
“Healthcare regulation continues to evolve and it’s a complicated area,” Aebel told GI & Hepatology News. “Some physician investors in healthcare ventures see the potential profits but are not fully aware of how a physician’s license and livelihood could be affected by noncompliance.”
Aebel has seen some medical business owners and institutions pushing physicians to their limits in order to maximize profits. “They’re failing to allow them the meaningful things that allow for a long-term productive and successful practice that provides great patient care,” she said. “A current issue I’m dealing with is employers’ taking away physicians’ administrative time and not respecting the work that is necessary for the physician to be efficient and provide great care,” she said. “If too many physicians get squeezed in this manner, they will eventually walk away from big employers to something they can better control.”
Aebel noted that private-equity acquisitions of medical practices — a fast-growing US trend — are often targeted at quick profits and quick exits, which can be inconsistent with quality long-term patient care. “A question to be asked by physicians and patients is who is benefiting from this transaction?” she said. “Sometimes retired physicians can see a great benefit in private equity, but newer physicians can get tied up with a strong noncompete agreement. The best deals are ones that try to find wins for all involved, including patients.”
Many independent gastroenterologists focusing on the demands of daily practice are less aware than they should be of the legal and business administration sides. “I often get clients who come to me complaining about their contracts after they’ve signed them. I don’t have leverage to do as much for them,” she admitted.
From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control. These could relate to compensation and bonuses, as well as opportunities to invest in the practice, the practice management company, and possibly real estate or ambulatory surgery centers (ASCs).
Aebel’s overarching messages to gastroenterologists are as follows: “Be aware. Learn basic health law. Read your contracts before you sign them. And invest in good counsel before you sign agreements,” she said. “In addition, GI practitioners need to have a working knowledge of the federal Anti-Kickback Statute and the federal Stark Law and how they could be commonly applied in their practices.”
These are designed to protect government-funded patient care from monetary influence. The False Claims Act is another federal buttress against fraud and abuse, she said.
Update Details
Though not intended to be legal advice, Aebel’s update touches on several important medicolegal areas.
Stark Law on Self-Referrals
Gastroenterologists should be familiar with this federal law, a self-referral civil penalty statute regulating how physicians can pay themselves in practices that provide designated health services covered by federal healthcare programs such as Medicare or Medicaid.
For a Stark penalty to apply, there must be a physician referral to an entity (eg, lab, hospital, nutrition service, physiotherapy or radiotherapy center) in which the physician or a close family member has a financial interest.
Ambulatory Surgery Centers
Another common area vulnerable to federal fraud and abuse regulation is investment in ASCs. “Generally speaking, it is a felony to pay or be paid anything of value for Medicare or Medicaid business referrals,” Aebel wrote. This provision relates to the general restriction of the federal AKB statute.
A gastroenterologist referring Medicare patients to a center where that physician has an investment could technically violate this law because the physician will receive profit distributions from the referral. In addition to constituting a felony with potential jail time, violation of this statute is grounds for substantial civil monetary penalties and/or exclusion from the government coverage program.
Fortunately, Aebel noted, legal safe harbors cover many financial relationships, including investment in an ASC. The financial arrangement is protected from prosecution if it meets five safe harbor requirements, including nondiscriminatory treatment of government-insured patients and physician investment unrelated to a center’s volume or the value of referrals. If even one aspect is not met, that will automatically constitute a crime.
“However, the government will look at facts and circumstances to determine whether there was an intent to pay for a referral,” Aebel wrote.
The safe harbor designates requirements for four types of ASCs: surgeon-owned, single-specialty, multispecialty, and hospital/physician ASCs.
Private-Equity Investment
With mergers and acquisitions of US medical practices and networks by private-equity firms becoming more common, gastroenterologists need to be aware of the legal issues involved in such investment.
Most states abide by corporate practice of medicine doctrines, which prohibit unlicensed people from direct ownership in a medical practice. These doctrines vary by state, but their primary goal is to ensure that medical decisions are made solely based on patient care and not influenced by corporate interests. The aim is to shield the physician-patient relationship from commercial influence.
“Accordingly, this creates additional complicated structures necessary for private-equity investment in gastroenterology practices,” Aebel wrote. Usually, such investors will invest in a management services organization (MSO), which takes much of the practice’s value via management fees. Gastroenterologists may or may not have an opportunity to invest in the practice and the MSO in this scenario.
Under corporate practice of medicine doctrine, physicians must control the clinical aspects of patient care. Therefore, some states may have restrictions on private-equity companies’ control of the use of medical devices, pricing, medical protocols, or other issues of patient care.
“This needs to be considered when reviewing the investment documents and structural documents proposed by private equity companies,” the advisory stated. From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control over their clinical practice. “This could relate to their compensation, bonuses, and investment opportunities in the practice, the practice management company, and possibly real estate or ASCs.”
Offering a gastroenterologist’s perspective on the paper, Camille Thélin, MD, MSc, an associate professor in the Division of Digestive Diseases and Health at the University of South Florida, Tampa, Florida, who also practices privately, said, that “what Erin Aebel reminds us is that the business side of GI can be just as tricky as the clinical side. Ancillary services like capsule studies or office labs fall under strict Stark rules, ASC ownership has Anti-Kickback Law restrictions, and private-equity deals may affect both your paycheck and your autonomy.”
Thélin’s main takeaway advice is that business opportunities can be valuable but carry real legal risks if not structured correctly. “This isn’t just abstract compliance law — it’s about protecting one’s ability to practice medicine, earn fairly, and avoid devastating penalties,” she told GI & Hepatology News. “This article reinforces the need for proactive legal review and careful structuring of business arrangements so physicians can focus on patient care without stumbling into avoidable legal pitfalls. With the right legal structure, ancillaries, ASCs, and private equity can strengthen your GI practice without risking compliance.”
The bottom line, said Aebel, is that gastroenterologists already in private practice or considering entering one must navigate a complex landscape of compliance and regulatory requirements — particularly when providing ancillary services, investing in ASCs, or engaging with private equity.
Understanding the Stark law, the AKB statute, and the intricacies of private-equity investment is essential to mitigate risks and avoid severe penalties, the advisory stressed. By proactively seeking expert legal and business guidance, gastroenterologists can structure their financial and ownership arrangements in a compliant manner, safeguarding their practices while capitalizing on growth opportunities.
This paper listed no external funding. Neither Aebel nor Thélin had any relevant conflicts of interest.
A version of this article appeared on Medscape.com.
The need for gastroenterology (GI) services is on the rise in the US, with growing rates of colonoscopy, earlier-onset colon cancer, and inflammatory bowel disease. This increase is taking place in the context of a changing regulatory landscape.
, and to that end, a recent educational practice management update was published in Clinical Gastroenterology and Hepatology by Erin Smith Aebel, JD, a health law specialist with Trenam Law in Tampa, Florida. Aebel has been a speaker at several national GI conferences and has addressed GI trainees on these issues in medical schools.
“Healthcare regulation continues to evolve and it’s a complicated area,” Aebel told GI & Hepatology News. “Some physician investors in healthcare ventures see the potential profits but are not fully aware of how a physician’s license and livelihood could be affected by noncompliance.”
Aebel has seen some medical business owners and institutions pushing physicians to their limits in order to maximize profits. “They’re failing to allow them the meaningful things that allow for a long-term productive and successful practice that provides great patient care,” she said. “A current issue I’m dealing with is employers’ taking away physicians’ administrative time and not respecting the work that is necessary for the physician to be efficient and provide great care,” she said. “If too many physicians get squeezed in this manner, they will eventually walk away from big employers to something they can better control.”
Aebel noted that private-equity acquisitions of medical practices — a fast-growing US trend — are often targeted at quick profits and quick exits, which can be inconsistent with quality long-term patient care. “A question to be asked by physicians and patients is who is benefiting from this transaction?” she said. “Sometimes retired physicians can see a great benefit in private equity, but newer physicians can get tied up with a strong noncompete agreement. The best deals are ones that try to find wins for all involved, including patients.”
Many independent gastroenterologists focusing on the demands of daily practice are less aware than they should be of the legal and business administration sides. “I often get clients who come to me complaining about their contracts after they’ve signed them. I don’t have leverage to do as much for them,” she admitted.
From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control. These could relate to compensation and bonuses, as well as opportunities to invest in the practice, the practice management company, and possibly real estate or ambulatory surgery centers (ASCs).
Aebel’s overarching messages to gastroenterologists are as follows: “Be aware. Learn basic health law. Read your contracts before you sign them. And invest in good counsel before you sign agreements,” she said. “In addition, GI practitioners need to have a working knowledge of the federal Anti-Kickback Statute and the federal Stark Law and how they could be commonly applied in their practices.”
These are designed to protect government-funded patient care from monetary influence. The False Claims Act is another federal buttress against fraud and abuse, she said.
Update Details
Though not intended to be legal advice, Aebel’s update touches on several important medicolegal areas.
Stark Law on Self-Referrals
Gastroenterologists should be familiar with this federal law, a self-referral civil penalty statute regulating how physicians can pay themselves in practices that provide designated health services covered by federal healthcare programs such as Medicare or Medicaid.
For a Stark penalty to apply, there must be a physician referral to an entity (eg, lab, hospital, nutrition service, physiotherapy or radiotherapy center) in which the physician or a close family member has a financial interest.
Ambulatory Surgery Centers
Another common area vulnerable to federal fraud and abuse regulation is investment in ASCs. “Generally speaking, it is a felony to pay or be paid anything of value for Medicare or Medicaid business referrals,” Aebel wrote. This provision relates to the general restriction of the federal AKB statute.
A gastroenterologist referring Medicare patients to a center where that physician has an investment could technically violate this law because the physician will receive profit distributions from the referral. In addition to constituting a felony with potential jail time, violation of this statute is grounds for substantial civil monetary penalties and/or exclusion from the government coverage program.
Fortunately, Aebel noted, legal safe harbors cover many financial relationships, including investment in an ASC. The financial arrangement is protected from prosecution if it meets five safe harbor requirements, including nondiscriminatory treatment of government-insured patients and physician investment unrelated to a center’s volume or the value of referrals. If even one aspect is not met, that will automatically constitute a crime.
“However, the government will look at facts and circumstances to determine whether there was an intent to pay for a referral,” Aebel wrote.
The safe harbor designates requirements for four types of ASCs: surgeon-owned, single-specialty, multispecialty, and hospital/physician ASCs.
Private-Equity Investment
With mergers and acquisitions of US medical practices and networks by private-equity firms becoming more common, gastroenterologists need to be aware of the legal issues involved in such investment.
Most states abide by corporate practice of medicine doctrines, which prohibit unlicensed people from direct ownership in a medical practice. These doctrines vary by state, but their primary goal is to ensure that medical decisions are made solely based on patient care and not influenced by corporate interests. The aim is to shield the physician-patient relationship from commercial influence.
“Accordingly, this creates additional complicated structures necessary for private-equity investment in gastroenterology practices,” Aebel wrote. Usually, such investors will invest in a management services organization (MSO), which takes much of the practice’s value via management fees. Gastroenterologists may or may not have an opportunity to invest in the practice and the MSO in this scenario.
Under corporate practice of medicine doctrine, physicians must control the clinical aspects of patient care. Therefore, some states may have restrictions on private-equity companies’ control of the use of medical devices, pricing, medical protocols, or other issues of patient care.
“This needs to be considered when reviewing the investment documents and structural documents proposed by private equity companies,” the advisory stated. From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control over their clinical practice. “This could relate to their compensation, bonuses, and investment opportunities in the practice, the practice management company, and possibly real estate or ASCs.”
Offering a gastroenterologist’s perspective on the paper, Camille Thélin, MD, MSc, an associate professor in the Division of Digestive Diseases and Health at the University of South Florida, Tampa, Florida, who also practices privately, said, that “what Erin Aebel reminds us is that the business side of GI can be just as tricky as the clinical side. Ancillary services like capsule studies or office labs fall under strict Stark rules, ASC ownership has Anti-Kickback Law restrictions, and private-equity deals may affect both your paycheck and your autonomy.”
Thélin’s main takeaway advice is that business opportunities can be valuable but carry real legal risks if not structured correctly. “This isn’t just abstract compliance law — it’s about protecting one’s ability to practice medicine, earn fairly, and avoid devastating penalties,” she told GI & Hepatology News. “This article reinforces the need for proactive legal review and careful structuring of business arrangements so physicians can focus on patient care without stumbling into avoidable legal pitfalls. With the right legal structure, ancillaries, ASCs, and private equity can strengthen your GI practice without risking compliance.”
The bottom line, said Aebel, is that gastroenterologists already in private practice or considering entering one must navigate a complex landscape of compliance and regulatory requirements — particularly when providing ancillary services, investing in ASCs, or engaging with private equity.
Understanding the Stark law, the AKB statute, and the intricacies of private-equity investment is essential to mitigate risks and avoid severe penalties, the advisory stressed. By proactively seeking expert legal and business guidance, gastroenterologists can structure their financial and ownership arrangements in a compliant manner, safeguarding their practices while capitalizing on growth opportunities.
This paper listed no external funding. Neither Aebel nor Thélin had any relevant conflicts of interest.
A version of this article appeared on Medscape.com.
The need for gastroenterology (GI) services is on the rise in the US, with growing rates of colonoscopy, earlier-onset colon cancer, and inflammatory bowel disease. This increase is taking place in the context of a changing regulatory landscape.
, and to that end, a recent educational practice management update was published in Clinical Gastroenterology and Hepatology by Erin Smith Aebel, JD, a health law specialist with Trenam Law in Tampa, Florida. Aebel has been a speaker at several national GI conferences and has addressed GI trainees on these issues in medical schools.
“Healthcare regulation continues to evolve and it’s a complicated area,” Aebel told GI & Hepatology News. “Some physician investors in healthcare ventures see the potential profits but are not fully aware of how a physician’s license and livelihood could be affected by noncompliance.”
Aebel has seen some medical business owners and institutions pushing physicians to their limits in order to maximize profits. “They’re failing to allow them the meaningful things that allow for a long-term productive and successful practice that provides great patient care,” she said. “A current issue I’m dealing with is employers’ taking away physicians’ administrative time and not respecting the work that is necessary for the physician to be efficient and provide great care,” she said. “If too many physicians get squeezed in this manner, they will eventually walk away from big employers to something they can better control.”
Aebel noted that private-equity acquisitions of medical practices — a fast-growing US trend — are often targeted at quick profits and quick exits, which can be inconsistent with quality long-term patient care. “A question to be asked by physicians and patients is who is benefiting from this transaction?” she said. “Sometimes retired physicians can see a great benefit in private equity, but newer physicians can get tied up with a strong noncompete agreement. The best deals are ones that try to find wins for all involved, including patients.”
Many independent gastroenterologists focusing on the demands of daily practice are less aware than they should be of the legal and business administration sides. “I often get clients who come to me complaining about their contracts after they’ve signed them. I don’t have leverage to do as much for them,” she admitted.
From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control. These could relate to compensation and bonuses, as well as opportunities to invest in the practice, the practice management company, and possibly real estate or ambulatory surgery centers (ASCs).
Aebel’s overarching messages to gastroenterologists are as follows: “Be aware. Learn basic health law. Read your contracts before you sign them. And invest in good counsel before you sign agreements,” she said. “In addition, GI practitioners need to have a working knowledge of the federal Anti-Kickback Statute and the federal Stark Law and how they could be commonly applied in their practices.”
These are designed to protect government-funded patient care from monetary influence. The False Claims Act is another federal buttress against fraud and abuse, she said.
Update Details
Though not intended to be legal advice, Aebel’s update touches on several important medicolegal areas.
Stark Law on Self-Referrals
Gastroenterologists should be familiar with this federal law, a self-referral civil penalty statute regulating how physicians can pay themselves in practices that provide designated health services covered by federal healthcare programs such as Medicare or Medicaid.
For a Stark penalty to apply, there must be a physician referral to an entity (eg, lab, hospital, nutrition service, physiotherapy or radiotherapy center) in which the physician or a close family member has a financial interest.
Ambulatory Surgery Centers
Another common area vulnerable to federal fraud and abuse regulation is investment in ASCs. “Generally speaking, it is a felony to pay or be paid anything of value for Medicare or Medicaid business referrals,” Aebel wrote. This provision relates to the general restriction of the federal AKB statute.
A gastroenterologist referring Medicare patients to a center where that physician has an investment could technically violate this law because the physician will receive profit distributions from the referral. In addition to constituting a felony with potential jail time, violation of this statute is grounds for substantial civil monetary penalties and/or exclusion from the government coverage program.
Fortunately, Aebel noted, legal safe harbors cover many financial relationships, including investment in an ASC. The financial arrangement is protected from prosecution if it meets five safe harbor requirements, including nondiscriminatory treatment of government-insured patients and physician investment unrelated to a center’s volume or the value of referrals. If even one aspect is not met, that will automatically constitute a crime.
“However, the government will look at facts and circumstances to determine whether there was an intent to pay for a referral,” Aebel wrote.
The safe harbor designates requirements for four types of ASCs: surgeon-owned, single-specialty, multispecialty, and hospital/physician ASCs.
Private-Equity Investment
With mergers and acquisitions of US medical practices and networks by private-equity firms becoming more common, gastroenterologists need to be aware of the legal issues involved in such investment.
Most states abide by corporate practice of medicine doctrines, which prohibit unlicensed people from direct ownership in a medical practice. These doctrines vary by state, but their primary goal is to ensure that medical decisions are made solely based on patient care and not influenced by corporate interests. The aim is to shield the physician-patient relationship from commercial influence.
“Accordingly, this creates additional complicated structures necessary for private-equity investment in gastroenterology practices,” Aebel wrote. Usually, such investors will invest in a management services organization (MSO), which takes much of the practice’s value via management fees. Gastroenterologists may or may not have an opportunity to invest in the practice and the MSO in this scenario.
Under corporate practice of medicine doctrine, physicians must control the clinical aspects of patient care. Therefore, some states may have restrictions on private-equity companies’ control of the use of medical devices, pricing, medical protocols, or other issues of patient care.
“This needs to be considered when reviewing the investment documents and structural documents proposed by private equity companies,” the advisory stated. From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control over their clinical practice. “This could relate to their compensation, bonuses, and investment opportunities in the practice, the practice management company, and possibly real estate or ASCs.”
Offering a gastroenterologist’s perspective on the paper, Camille Thélin, MD, MSc, an associate professor in the Division of Digestive Diseases and Health at the University of South Florida, Tampa, Florida, who also practices privately, said, that “what Erin Aebel reminds us is that the business side of GI can be just as tricky as the clinical side. Ancillary services like capsule studies or office labs fall under strict Stark rules, ASC ownership has Anti-Kickback Law restrictions, and private-equity deals may affect both your paycheck and your autonomy.”
Thélin’s main takeaway advice is that business opportunities can be valuable but carry real legal risks if not structured correctly. “This isn’t just abstract compliance law — it’s about protecting one’s ability to practice medicine, earn fairly, and avoid devastating penalties,” she told GI & Hepatology News. “This article reinforces the need for proactive legal review and careful structuring of business arrangements so physicians can focus on patient care without stumbling into avoidable legal pitfalls. With the right legal structure, ancillaries, ASCs, and private equity can strengthen your GI practice without risking compliance.”
The bottom line, said Aebel, is that gastroenterologists already in private practice or considering entering one must navigate a complex landscape of compliance and regulatory requirements — particularly when providing ancillary services, investing in ASCs, or engaging with private equity.
Understanding the Stark law, the AKB statute, and the intricacies of private-equity investment is essential to mitigate risks and avoid severe penalties, the advisory stressed. By proactively seeking expert legal and business guidance, gastroenterologists can structure their financial and ownership arrangements in a compliant manner, safeguarding their practices while capitalizing on growth opportunities.
This paper listed no external funding. Neither Aebel nor Thélin had any relevant conflicts of interest.
A version of this article appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Fecal Transplant Benefits in Primary C Difficile Infection Similar to Vancomycin
, with efficacy that is comparable to the standard treatment of vancomycin, and in some measures, showing even stronger efficacy, new research showed.
“FMT, prepared and administered according to international guidelines, is an effective and safe treatment option for C difficile infections, which should be considered for all patients with the infection,” first author Frederik Emil Juul, MD, PhD, of the Clinical Effectiveness Research Group, University of Oslo, in Oslo, Norway, told GI & Hepatology News.
FMT even showed a numerical superiority to vancomycin, which, though not statistically significant, “indicates that FMT has the potential to change the current practice of antibiotic therapy and may establish FMT as a first-line treatment for primary CDI,” the authors further asserted in the study, published recently in the Annals of Internal Medicine.
In the treatment of antibiotic-associated colitis due to CDI, vancomycin or fidaxomicin are the standard therapies, yet up to 20% of patients experience one or more symptom recurrences following successful initial antibiotic treatment, prompting the need for continued antibiotic regimens, resulting in increased costs and potential adverse events, while contributing to antibiotic resistance.
FMT, designed to restore a normal functional colonic microenvironment with the transfer of a healthy person’s stool, though still somewhat controversial, has gained acceptance and favor in recent years in the treatment of recurrent CDI, however, research has been lacking on its efficacy in the treatment of primary CDI.
With a previous proof-of-concept trial and observational study showing promising results in primary CDI, Juul and colleagues conducted the current randomized, open-label noninferiority trial.
For the multi-center study, 100 adult patients with CDI, defined as C diff toxin in stool and at least three loose stools daily, and no previous CDI within 1 year prior to enrollment, were randomized at 20 hospitals in Norway to receive either FMT, administered as an enema, without antibiotic pretreatment, or oral vancomycin at a dose of 125 mg, four times daily for 10 days.
The patients had a median age of about 70 years; more than 40% of patients had a Charlson Comorbidity Index score of ≥ 4, indicating severe comorbidity, and a third had severe CDI.
With the trial showing favorable results, a data and safety monitoring board recommended stopping the trial for efficacy and noninferiority after about half of the planned enrollment was reached.
The primary endpoint of a clinical cure, defined as firm stools or less than three bowel movements daily and no disease recurrence within 60 days without additional treatment, was observed in 34 of 51 patients who received FMT (66.7%) compared with 30 of 49 of those receiving vancomycin (61.2%; difference, 5.4 percentage points; P for noninferiority < .001).
The results contradict the theory that response to FMT is 25 percentage points lower than response to vancomycin, the authors noted.
The proportion of patients with clinical cure at day 14 was 70.6% in the FMT group and 77.6% in the vancomycin group, and among those patients, two (5.6%) in the FMT group had disease recurrence compared with eight (21.1%) in the vancomycin group between days 15 and 60.
In the FMT group, 11 patients received additional treatment compared with four in the vancomycin group, predominantly oral vancomycin in both groups.
Despite the high rates of severe comorbidity among the patients at baseline, a subgroup analyses showed no significant differences in treatment effects based on factors including sex, age group, Charlson Comorbidity Index score, or CDI severity.
Importantly, there were also no significant differences in adverse events between the groups.
“Our results indicate that it is reasonable to treat patients with primary CDI with FMT and provide antibiotics only to patients with ongoing symptoms or recurrence after FMT,” the authors concluded.
FMT Faces Challenges in the US
FMT specifically consists of direct instillation of fecal matter to the upper gastrointestinal tract, via capsules or duodenal infusion, or the lower gastrointestinal tract via colonoscopy or enema.
While an AGA guideline issued in 2024 endorsed FMT for the prevention of recurrent, refractory, or fulminant CDI in select adults not responding to standard antibiotics, the association underscored important caveats, including a low quality of evidence, and concluded that FMT could not yet be recommended for other gastrointestinal conditions.
The treatment meanwhile has faced an uphill battle in the US. The provision of screened FMT inocula through the nonprofit OpenBiome, previously the country’s largest stool bank, was recently suspended amid FDA policy changes.
And while other commercial-grade biotherapeutic products Rebyota and Vowst, have received FDA approval, cost and insurance coverage can be significant barriers, said Elizabeth Hohmann, MD, of the Infectious Disease Division at Massachusetts General Hospital, Boston, in an editorial published with the study.
“Currently approved options are expensive and are not available to many who might benefit for various reasons, primarily cost,” she said.
Acceptance Higher in Europe
In Europe, and particularly Norway, acceptance of FMT for CDI and other indications has been more favorable, and while regulation of the treatment has varied among European countries, a new regulation to be implemented by the European Union in 2027 will improve standardization of the production, handling, storage, and other factors of FMT, Juul told GI & Hepatology News.
“I believe the new regulations will make the treatment more available to patients, and a standardization of the FMT production will make future trials more comparable and useful across countries,” he said.
Juul said he further expects that “our results will lower the threshold for choosing FMT as treatment in primary infections. I know that Denmark also gives FMT to patients with primary CDI.”
Quality of Life
Hohmann, who has treated many patients with recurrent CDI with FMT, noted that a key factor that should be underscored is how much better patients can feel after the treatment.
“Although there are no quality of life surveys in [the current study], had they been done, I suspect quality of life might have been higher in the FMT group; in my experience, people feel better after microbiome restoration.”
She added that her patients “report feeling much better, and that’s why I keep doing it,” she said. “I’ve had an 80-year-old patient tell me he’s going back to snow shoveling; another saying she can return to yoga classes.”
“When you have had bad gut microbiome dysbiosis that becomes normal, you feel a lot better,” Hohmann said.
In the treatment of primary CDI, however, Hohmann said the prospects, at least in the US, are likely slim.
“I do not believe that we in the United States will see FMT as a primary treatment of C difficile infection anytime soon,” she wrote in the editorial.
Nevertheless, Hohmann asserted that “FMT should remain available, with appropriate sources of carefully screened inocula for care and for further research into the many illnesses and therapies that are influenced by the health of the gut microbiome.”
This study received funding from the South-East Norway Health Trust. Hohmann had no disclosures to report.
A version of this article appeared on Medscape.com.
, with efficacy that is comparable to the standard treatment of vancomycin, and in some measures, showing even stronger efficacy, new research showed.
“FMT, prepared and administered according to international guidelines, is an effective and safe treatment option for C difficile infections, which should be considered for all patients with the infection,” first author Frederik Emil Juul, MD, PhD, of the Clinical Effectiveness Research Group, University of Oslo, in Oslo, Norway, told GI & Hepatology News.
FMT even showed a numerical superiority to vancomycin, which, though not statistically significant, “indicates that FMT has the potential to change the current practice of antibiotic therapy and may establish FMT as a first-line treatment for primary CDI,” the authors further asserted in the study, published recently in the Annals of Internal Medicine.
In the treatment of antibiotic-associated colitis due to CDI, vancomycin or fidaxomicin are the standard therapies, yet up to 20% of patients experience one or more symptom recurrences following successful initial antibiotic treatment, prompting the need for continued antibiotic regimens, resulting in increased costs and potential adverse events, while contributing to antibiotic resistance.
FMT, designed to restore a normal functional colonic microenvironment with the transfer of a healthy person’s stool, though still somewhat controversial, has gained acceptance and favor in recent years in the treatment of recurrent CDI, however, research has been lacking on its efficacy in the treatment of primary CDI.
With a previous proof-of-concept trial and observational study showing promising results in primary CDI, Juul and colleagues conducted the current randomized, open-label noninferiority trial.
For the multi-center study, 100 adult patients with CDI, defined as C diff toxin in stool and at least three loose stools daily, and no previous CDI within 1 year prior to enrollment, were randomized at 20 hospitals in Norway to receive either FMT, administered as an enema, without antibiotic pretreatment, or oral vancomycin at a dose of 125 mg, four times daily for 10 days.
The patients had a median age of about 70 years; more than 40% of patients had a Charlson Comorbidity Index score of ≥ 4, indicating severe comorbidity, and a third had severe CDI.
With the trial showing favorable results, a data and safety monitoring board recommended stopping the trial for efficacy and noninferiority after about half of the planned enrollment was reached.
The primary endpoint of a clinical cure, defined as firm stools or less than three bowel movements daily and no disease recurrence within 60 days without additional treatment, was observed in 34 of 51 patients who received FMT (66.7%) compared with 30 of 49 of those receiving vancomycin (61.2%; difference, 5.4 percentage points; P for noninferiority < .001).
The results contradict the theory that response to FMT is 25 percentage points lower than response to vancomycin, the authors noted.
The proportion of patients with clinical cure at day 14 was 70.6% in the FMT group and 77.6% in the vancomycin group, and among those patients, two (5.6%) in the FMT group had disease recurrence compared with eight (21.1%) in the vancomycin group between days 15 and 60.
In the FMT group, 11 patients received additional treatment compared with four in the vancomycin group, predominantly oral vancomycin in both groups.
Despite the high rates of severe comorbidity among the patients at baseline, a subgroup analyses showed no significant differences in treatment effects based on factors including sex, age group, Charlson Comorbidity Index score, or CDI severity.
Importantly, there were also no significant differences in adverse events between the groups.
“Our results indicate that it is reasonable to treat patients with primary CDI with FMT and provide antibiotics only to patients with ongoing symptoms or recurrence after FMT,” the authors concluded.
FMT Faces Challenges in the US
FMT specifically consists of direct instillation of fecal matter to the upper gastrointestinal tract, via capsules or duodenal infusion, or the lower gastrointestinal tract via colonoscopy or enema.
While an AGA guideline issued in 2024 endorsed FMT for the prevention of recurrent, refractory, or fulminant CDI in select adults not responding to standard antibiotics, the association underscored important caveats, including a low quality of evidence, and concluded that FMT could not yet be recommended for other gastrointestinal conditions.
The treatment meanwhile has faced an uphill battle in the US. The provision of screened FMT inocula through the nonprofit OpenBiome, previously the country’s largest stool bank, was recently suspended amid FDA policy changes.
And while other commercial-grade biotherapeutic products Rebyota and Vowst, have received FDA approval, cost and insurance coverage can be significant barriers, said Elizabeth Hohmann, MD, of the Infectious Disease Division at Massachusetts General Hospital, Boston, in an editorial published with the study.
“Currently approved options are expensive and are not available to many who might benefit for various reasons, primarily cost,” she said.
Acceptance Higher in Europe
In Europe, and particularly Norway, acceptance of FMT for CDI and other indications has been more favorable, and while regulation of the treatment has varied among European countries, a new regulation to be implemented by the European Union in 2027 will improve standardization of the production, handling, storage, and other factors of FMT, Juul told GI & Hepatology News.
“I believe the new regulations will make the treatment more available to patients, and a standardization of the FMT production will make future trials more comparable and useful across countries,” he said.
Juul said he further expects that “our results will lower the threshold for choosing FMT as treatment in primary infections. I know that Denmark also gives FMT to patients with primary CDI.”
Quality of Life
Hohmann, who has treated many patients with recurrent CDI with FMT, noted that a key factor that should be underscored is how much better patients can feel after the treatment.
“Although there are no quality of life surveys in [the current study], had they been done, I suspect quality of life might have been higher in the FMT group; in my experience, people feel better after microbiome restoration.”
She added that her patients “report feeling much better, and that’s why I keep doing it,” she said. “I’ve had an 80-year-old patient tell me he’s going back to snow shoveling; another saying she can return to yoga classes.”
“When you have had bad gut microbiome dysbiosis that becomes normal, you feel a lot better,” Hohmann said.
In the treatment of primary CDI, however, Hohmann said the prospects, at least in the US, are likely slim.
“I do not believe that we in the United States will see FMT as a primary treatment of C difficile infection anytime soon,” she wrote in the editorial.
Nevertheless, Hohmann asserted that “FMT should remain available, with appropriate sources of carefully screened inocula for care and for further research into the many illnesses and therapies that are influenced by the health of the gut microbiome.”
This study received funding from the South-East Norway Health Trust. Hohmann had no disclosures to report.
A version of this article appeared on Medscape.com.
, with efficacy that is comparable to the standard treatment of vancomycin, and in some measures, showing even stronger efficacy, new research showed.
“FMT, prepared and administered according to international guidelines, is an effective and safe treatment option for C difficile infections, which should be considered for all patients with the infection,” first author Frederik Emil Juul, MD, PhD, of the Clinical Effectiveness Research Group, University of Oslo, in Oslo, Norway, told GI & Hepatology News.
FMT even showed a numerical superiority to vancomycin, which, though not statistically significant, “indicates that FMT has the potential to change the current practice of antibiotic therapy and may establish FMT as a first-line treatment for primary CDI,” the authors further asserted in the study, published recently in the Annals of Internal Medicine.
In the treatment of antibiotic-associated colitis due to CDI, vancomycin or fidaxomicin are the standard therapies, yet up to 20% of patients experience one or more symptom recurrences following successful initial antibiotic treatment, prompting the need for continued antibiotic regimens, resulting in increased costs and potential adverse events, while contributing to antibiotic resistance.
FMT, designed to restore a normal functional colonic microenvironment with the transfer of a healthy person’s stool, though still somewhat controversial, has gained acceptance and favor in recent years in the treatment of recurrent CDI, however, research has been lacking on its efficacy in the treatment of primary CDI.
With a previous proof-of-concept trial and observational study showing promising results in primary CDI, Juul and colleagues conducted the current randomized, open-label noninferiority trial.
For the multi-center study, 100 adult patients with CDI, defined as C diff toxin in stool and at least three loose stools daily, and no previous CDI within 1 year prior to enrollment, were randomized at 20 hospitals in Norway to receive either FMT, administered as an enema, without antibiotic pretreatment, or oral vancomycin at a dose of 125 mg, four times daily for 10 days.
The patients had a median age of about 70 years; more than 40% of patients had a Charlson Comorbidity Index score of ≥ 4, indicating severe comorbidity, and a third had severe CDI.
With the trial showing favorable results, a data and safety monitoring board recommended stopping the trial for efficacy and noninferiority after about half of the planned enrollment was reached.
The primary endpoint of a clinical cure, defined as firm stools or less than three bowel movements daily and no disease recurrence within 60 days without additional treatment, was observed in 34 of 51 patients who received FMT (66.7%) compared with 30 of 49 of those receiving vancomycin (61.2%; difference, 5.4 percentage points; P for noninferiority < .001).
The results contradict the theory that response to FMT is 25 percentage points lower than response to vancomycin, the authors noted.
The proportion of patients with clinical cure at day 14 was 70.6% in the FMT group and 77.6% in the vancomycin group, and among those patients, two (5.6%) in the FMT group had disease recurrence compared with eight (21.1%) in the vancomycin group between days 15 and 60.
In the FMT group, 11 patients received additional treatment compared with four in the vancomycin group, predominantly oral vancomycin in both groups.
Despite the high rates of severe comorbidity among the patients at baseline, a subgroup analyses showed no significant differences in treatment effects based on factors including sex, age group, Charlson Comorbidity Index score, or CDI severity.
Importantly, there were also no significant differences in adverse events between the groups.
“Our results indicate that it is reasonable to treat patients with primary CDI with FMT and provide antibiotics only to patients with ongoing symptoms or recurrence after FMT,” the authors concluded.
FMT Faces Challenges in the US
FMT specifically consists of direct instillation of fecal matter to the upper gastrointestinal tract, via capsules or duodenal infusion, or the lower gastrointestinal tract via colonoscopy or enema.
While an AGA guideline issued in 2024 endorsed FMT for the prevention of recurrent, refractory, or fulminant CDI in select adults not responding to standard antibiotics, the association underscored important caveats, including a low quality of evidence, and concluded that FMT could not yet be recommended for other gastrointestinal conditions.
The treatment meanwhile has faced an uphill battle in the US. The provision of screened FMT inocula through the nonprofit OpenBiome, previously the country’s largest stool bank, was recently suspended amid FDA policy changes.
And while other commercial-grade biotherapeutic products Rebyota and Vowst, have received FDA approval, cost and insurance coverage can be significant barriers, said Elizabeth Hohmann, MD, of the Infectious Disease Division at Massachusetts General Hospital, Boston, in an editorial published with the study.
“Currently approved options are expensive and are not available to many who might benefit for various reasons, primarily cost,” she said.
Acceptance Higher in Europe
In Europe, and particularly Norway, acceptance of FMT for CDI and other indications has been more favorable, and while regulation of the treatment has varied among European countries, a new regulation to be implemented by the European Union in 2027 will improve standardization of the production, handling, storage, and other factors of FMT, Juul told GI & Hepatology News.
“I believe the new regulations will make the treatment more available to patients, and a standardization of the FMT production will make future trials more comparable and useful across countries,” he said.
Juul said he further expects that “our results will lower the threshold for choosing FMT as treatment in primary infections. I know that Denmark also gives FMT to patients with primary CDI.”
Quality of Life
Hohmann, who has treated many patients with recurrent CDI with FMT, noted that a key factor that should be underscored is how much better patients can feel after the treatment.
“Although there are no quality of life surveys in [the current study], had they been done, I suspect quality of life might have been higher in the FMT group; in my experience, people feel better after microbiome restoration.”
She added that her patients “report feeling much better, and that’s why I keep doing it,” she said. “I’ve had an 80-year-old patient tell me he’s going back to snow shoveling; another saying she can return to yoga classes.”
“When you have had bad gut microbiome dysbiosis that becomes normal, you feel a lot better,” Hohmann said.
In the treatment of primary CDI, however, Hohmann said the prospects, at least in the US, are likely slim.
“I do not believe that we in the United States will see FMT as a primary treatment of C difficile infection anytime soon,” she wrote in the editorial.
Nevertheless, Hohmann asserted that “FMT should remain available, with appropriate sources of carefully screened inocula for care and for further research into the many illnesses and therapies that are influenced by the health of the gut microbiome.”
This study received funding from the South-East Norway Health Trust. Hohmann had no disclosures to report.
A version of this article appeared on Medscape.com.