News

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved tisotumab vedotin (Genmab AS) for adults with recurrent or metastatic cervical cancer.

The decision, made via the International Recognition Procedure, applies to patients whose disease has progressed after prior systemic therapy. It provides a new treatment option for a high-risk group with limited alternatives.

How the Treatment Works

Tisotumab vedotin is an antibody-drug conjugate that combines a tissue factor-directed human monoclonal antibody with monomethyl auristatin E, a microtubule-disrupting agent. The therapy targets tissue factor, which is overexpressed in a several solid tumours, including recurrent cervical cancer.

It is administered as a 30-minute intravenous infusion once every 3 weeks.

What Trials Showed

The approval is based on evidence from multiple clinical studies demonstrating tisotumab vedotin's efficacy in previously treated patients.

In the phase 2 innovaTV 204 study, 102 patients were enrolled and 101 received at least 1 dose of tisotumab vedotin. The confirmed objective response rate was 24%, including seven complete responses and 17 partial responses, demonstrating clinically meaningful activity in a heavily pretreated population.

Further evidence came from the phase 3 innovaTV-301 trial, which randomly assigned 502 patients to receive either tisotumab vedotin or investigator's-choice chemotherapy.

Median overall survival was 11.5 months with the new therapy compared with 9.5 months in the chemotherapy arm, translating to roughly a 30% reduction in the risk for death. The confirmed objective response rate was also significantly higher with tisotumab vedotin—17.8% vs 5.2%—underscoring its advantage over standard treatment options.

Safety and Tolerability

Ocular toxicity and peripheral neuropathy were the most notable adverse reactions.

Common treatment-related events in the phase 2 study included alopecia (38%), epistaxis (30%), nausea, conjunctivitis (26%), and fatigue (26%).

Grade 3 or higher treatment-related adverse events occurred in about 28% of patients. Clinicians should be alert to conjunctivitis and keratitis as well as sensory neuropathic symptoms (numbness, tingling, or a burning sensation in the hands and feet).

Julian Beach, interim executive director of healthcare quality and access at the MHRA, said that patient safety is the agency's "top priority." "We will continue to monitor its safety closely as it becomes more widely used," he added.

The Summary of Product Characteristics and Patient Information Leaflets will be published on the MHRA website within 7 days of approval.

A version of this article first appeared on Medscape.com.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved tisotumab vedotin (Genmab AS) for adults with recurrent or metastatic cervical cancer.

The decision, made via the International Recognition Procedure, applies to patients whose disease has progressed after prior systemic therapy. It provides a new treatment option for a high-risk group with limited alternatives.

How the Treatment Works

Tisotumab vedotin is an antibody-drug conjugate that combines a tissue factor-directed human monoclonal antibody with monomethyl auristatin E, a microtubule-disrupting agent. The therapy targets tissue factor, which is overexpressed in a several solid tumours, including recurrent cervical cancer.

It is administered as a 30-minute intravenous infusion once every 3 weeks.

What Trials Showed

The approval is based on evidence from multiple clinical studies demonstrating tisotumab vedotin's efficacy in previously treated patients.

In the phase 2 innovaTV 204 study, 102 patients were enrolled and 101 received at least 1 dose of tisotumab vedotin. The confirmed objective response rate was 24%, including seven complete responses and 17 partial responses, demonstrating clinically meaningful activity in a heavily pretreated population.

Further evidence came from the phase 3 innovaTV-301 trial, which randomly assigned 502 patients to receive either tisotumab vedotin or investigator's-choice chemotherapy.

Median overall survival was 11.5 months with the new therapy compared with 9.5 months in the chemotherapy arm, translating to roughly a 30% reduction in the risk for death. The confirmed objective response rate was also significantly higher with tisotumab vedotin—17.8% vs 5.2%—underscoring its advantage over standard treatment options.

Safety and Tolerability

Ocular toxicity and peripheral neuropathy were the most notable adverse reactions.

Common treatment-related events in the phase 2 study included alopecia (38%), epistaxis (30%), nausea, conjunctivitis (26%), and fatigue (26%).

Grade 3 or higher treatment-related adverse events occurred in about 28% of patients. Clinicians should be alert to conjunctivitis and keratitis as well as sensory neuropathic symptoms (numbness, tingling, or a burning sensation in the hands and feet).

Julian Beach, interim executive director of healthcare quality and access at the MHRA, said that patient safety is the agency's "top priority." "We will continue to monitor its safety closely as it becomes more widely used," he added.

The Summary of Product Characteristics and Patient Information Leaflets will be published on the MHRA website within 7 days of approval.

A version of this article first appeared on Medscape.com.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved tisotumab vedotin (Genmab AS) for adults with recurrent or metastatic cervical cancer.

The decision, made via the International Recognition Procedure, applies to patients whose disease has progressed after prior systemic therapy. It provides a new treatment option for a high-risk group with limited alternatives.

How the Treatment Works

Tisotumab vedotin is an antibody-drug conjugate that combines a tissue factor-directed human monoclonal antibody with monomethyl auristatin E, a microtubule-disrupting agent. The therapy targets tissue factor, which is overexpressed in a several solid tumours, including recurrent cervical cancer.

It is administered as a 30-minute intravenous infusion once every 3 weeks.

What Trials Showed

The approval is based on evidence from multiple clinical studies demonstrating tisotumab vedotin's efficacy in previously treated patients.

In the phase 2 innovaTV 204 study, 102 patients were enrolled and 101 received at least 1 dose of tisotumab vedotin. The confirmed objective response rate was 24%, including seven complete responses and 17 partial responses, demonstrating clinically meaningful activity in a heavily pretreated population.

Further evidence came from the phase 3 innovaTV-301 trial, which randomly assigned 502 patients to receive either tisotumab vedotin or investigator's-choice chemotherapy.

Median overall survival was 11.5 months with the new therapy compared with 9.5 months in the chemotherapy arm, translating to roughly a 30% reduction in the risk for death. The confirmed objective response rate was also significantly higher with tisotumab vedotin—17.8% vs 5.2%—underscoring its advantage over standard treatment options.

Safety and Tolerability

Ocular toxicity and peripheral neuropathy were the most notable adverse reactions.

Common treatment-related events in the phase 2 study included alopecia (38%), epistaxis (30%), nausea, conjunctivitis (26%), and fatigue (26%).

Grade 3 or higher treatment-related adverse events occurred in about 28% of patients. Clinicians should be alert to conjunctivitis and keratitis as well as sensory neuropathic symptoms (numbness, tingling, or a burning sensation in the hands and feet).

Julian Beach, interim executive director of healthcare quality and access at the MHRA, said that patient safety is the agency's "top priority." "We will continue to monitor its safety closely as it becomes more widely used," he added.

The Summary of Product Characteristics and Patient Information Leaflets will be published on the MHRA website within 7 days of approval.

A version of this article first appeared on Medscape.com.

PHOENIX – For patients who suffer from persistent symptoms of gastroesophageal reflux disease (GERD) despite therapy, the first step is symptom evaluation, said Kristle L. Lynch, MD, in a presentation at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

Patients with persistent GERD who have cough and asthma, as well as those with hoarseness, globus, or other ear, nose, and throat concerns, may first undergo workup by other clinicians, said Lynch, who is a professor of clinical medicine and director of the Physiology and Motility Laboratory at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.

With these patients, “given the low pretest probability of an acid reflux source, it makes sense to bypass a trial of acid-suppressing medication if symptoms persist and instead move on to consideration of upper endoscopy,” she said.

“If negative for damage or sequelae of reflux, this test is often followed by advanced reflux testing and high-resolution manometry, to help diagnose the cause of reflux and swallowing problems,” she noted.

For patients with heartburn, regurgitation, or noncardiac chest pain (and no other concerning symptoms), moving to an empiric trial of antisecretory therapy before endoscopy can be reasonable, Lynch said. But if symptoms persist, an endoscopy should be done before any advanced pH testing.
 

Advanced pH Testing Options

Advanced reflux testing options for persistent GERD after an endoscopy include catheter-based pH-impedance testing and wireless pH testing, said Lynch.

“Wireless pH monitoring offers improved patient comfort by eliminating the need for a nasal catheter, allowing individuals to maintain normal daily activities and diet during testing,” Lynch told GI & Hepatology News.

“It also enables extended monitoring periods of up to 96 hours, enhancing the detection of intermittent acid reflux episodes,” she said. “However, unlike pH-impedance catheter-based testing, wireless pH measures only acid exposure and cannot identify nonacid reflux events.”

In addition, the wireless capsule may detach prematurely or cause mild chest discomfort, and its endoscopic placement adds procedural complexity with the need for anesthesia, as well as additional cost, she noted.

Catheter-based pH-impedance testing involves sedation-free catheter placement while the patient is awake, followed by monitoring for 24 hours, and involves assessment of bolus movement in tandem with pH measurements, Lynch said. The catheter monitors levels of acid refluxing into the esophagus and transmits this information to the smartphone-sized computer worn by the patient over the 24-hour period.

Unlike wireless testing, impedance testing allows for adjunctive measures of mean nocturnal baseline impedance (MNBI) and post-reflux swallow-induced peristaltic waves (PSPW), the latter of which is shown to predict response to proton pump inhibitor (PPI) therapy in patients with reflux.

Logistics include a concurrent manometry for the lower esophageal sphincter to optimize location, followed by a transnasal placement. Challenges associated with the catheter-based test include potential catheter migration and patient discomfort, she added.
 

Assessing pH Testing Results

After pH testing of either type, abnormal acid exposure time (AET) when the pH in the lower esophagus is greater than 6% supports a diagnosis of GERD; AET between 4% and 6% is considered borderline GERD; and AET less than 4% is considered normal and outside the bounds of pathologic reflux, as per the Lyon Consensus, Lynch explained.

Treatment for patients meeting the GERD criteria based on AET includes not only diet and lifestyle changes but also potential pharmacologics, including acid suppressants, alginates, gamma-aminobutyric acid agonists, and prokinetics. In some cases, anti-reflux surgery may be considered, such as magnetic sphincter augmentation, transoral incisionless fundoplication, or Roux-en-Y gastric bypass, Lynch said.

But not all heartburn in patients with persistent GERD is acid-related, she said. Functional heartburn and reflux hypersensitivity can be seen in these cases.

Patients not meeting the criteria for GERD on advanced pH testing and diagnosed with reflux hypersensitivity or functional heartburn may be treated with neuromodulators or nonpharmacologic therapies such as hypnosis, diaphragmatic breathing, cognitive-behavioral therapy, or acupuncture, said Lynch in her presentation.

Overall, “advanced pH testing should be assessed within the framework of other investigations and the patient as a whole,” she emphasized.
 

Challenges in the Clinic

One of the biggest mistakes while diagnosing a patient with persistent GERD symptoms despite PPI therapy is always assuming their symptoms are driven by ongoing pathologic acid exposure, said Michael Kingsley, MD, a gastroenterologist specializing in gastrointestinal motility disorders and a clinical assistant professor of medicine at the University of Pittsburgh, Pittsburgh, in an interview.

He agreed with Lynch that patients with reflux hypersensitivity or functional heartburn are more likely to benefit from interventions other than a PPI, such as a neuromodulator.

But managing GERD in the clinic also requires making time to assess whether patients are taking PPI correctly and to counsel them on lifestyle modifications, he noted.

One of the current biggest challenges in GERD is how best to manage a patient who falls into the inconclusive range of not definitely normal or abnormal on pH testing, Kingsley told GI & Hepatology News. 

“As alluded to in this talk, MNBI and PSPW are emerging metrics, both of which require a pH-impedance study (as opposed to a wireless pH study),” he said. “Further elucidating the ideal application and cutoffs of these metrics may provide additional tools for best treating patients who fall into the “inconclusive” range with standard metrics.”

Lynch and Kingsley disclosed no financial conflicts of interest.
 

A version of this article appeared on Medscape.com . 

PHOENIX – For patients who suffer from persistent symptoms of gastroesophageal reflux disease (GERD) despite therapy, the first step is symptom evaluation, said Kristle L. Lynch, MD, in a presentation at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

Patients with persistent GERD who have cough and asthma, as well as those with hoarseness, globus, or other ear, nose, and throat concerns, may first undergo workup by other clinicians, said Lynch, who is a professor of clinical medicine and director of the Physiology and Motility Laboratory at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.

With these patients, “given the low pretest probability of an acid reflux source, it makes sense to bypass a trial of acid-suppressing medication if symptoms persist and instead move on to consideration of upper endoscopy,” she said.

“If negative for damage or sequelae of reflux, this test is often followed by advanced reflux testing and high-resolution manometry, to help diagnose the cause of reflux and swallowing problems,” she noted.

For patients with heartburn, regurgitation, or noncardiac chest pain (and no other concerning symptoms), moving to an empiric trial of antisecretory therapy before endoscopy can be reasonable, Lynch said. But if symptoms persist, an endoscopy should be done before any advanced pH testing.
 

Advanced pH Testing Options

Advanced reflux testing options for persistent GERD after an endoscopy include catheter-based pH-impedance testing and wireless pH testing, said Lynch.

“Wireless pH monitoring offers improved patient comfort by eliminating the need for a nasal catheter, allowing individuals to maintain normal daily activities and diet during testing,” Lynch told GI & Hepatology News.

“It also enables extended monitoring periods of up to 96 hours, enhancing the detection of intermittent acid reflux episodes,” she said. “However, unlike pH-impedance catheter-based testing, wireless pH measures only acid exposure and cannot identify nonacid reflux events.”

In addition, the wireless capsule may detach prematurely or cause mild chest discomfort, and its endoscopic placement adds procedural complexity with the need for anesthesia, as well as additional cost, she noted.

Catheter-based pH-impedance testing involves sedation-free catheter placement while the patient is awake, followed by monitoring for 24 hours, and involves assessment of bolus movement in tandem with pH measurements, Lynch said. The catheter monitors levels of acid refluxing into the esophagus and transmits this information to the smartphone-sized computer worn by the patient over the 24-hour period.

Unlike wireless testing, impedance testing allows for adjunctive measures of mean nocturnal baseline impedance (MNBI) and post-reflux swallow-induced peristaltic waves (PSPW), the latter of which is shown to predict response to proton pump inhibitor (PPI) therapy in patients with reflux.

Logistics include a concurrent manometry for the lower esophageal sphincter to optimize location, followed by a transnasal placement. Challenges associated with the catheter-based test include potential catheter migration and patient discomfort, she added.
 

Assessing pH Testing Results

After pH testing of either type, abnormal acid exposure time (AET) when the pH in the lower esophagus is greater than 6% supports a diagnosis of GERD; AET between 4% and 6% is considered borderline GERD; and AET less than 4% is considered normal and outside the bounds of pathologic reflux, as per the Lyon Consensus, Lynch explained.

Treatment for patients meeting the GERD criteria based on AET includes not only diet and lifestyle changes but also potential pharmacologics, including acid suppressants, alginates, gamma-aminobutyric acid agonists, and prokinetics. In some cases, anti-reflux surgery may be considered, such as magnetic sphincter augmentation, transoral incisionless fundoplication, or Roux-en-Y gastric bypass, Lynch said.

But not all heartburn in patients with persistent GERD is acid-related, she said. Functional heartburn and reflux hypersensitivity can be seen in these cases.

Patients not meeting the criteria for GERD on advanced pH testing and diagnosed with reflux hypersensitivity or functional heartburn may be treated with neuromodulators or nonpharmacologic therapies such as hypnosis, diaphragmatic breathing, cognitive-behavioral therapy, or acupuncture, said Lynch in her presentation.

Overall, “advanced pH testing should be assessed within the framework of other investigations and the patient as a whole,” she emphasized.
 

Challenges in the Clinic

One of the biggest mistakes while diagnosing a patient with persistent GERD symptoms despite PPI therapy is always assuming their symptoms are driven by ongoing pathologic acid exposure, said Michael Kingsley, MD, a gastroenterologist specializing in gastrointestinal motility disorders and a clinical assistant professor of medicine at the University of Pittsburgh, Pittsburgh, in an interview.

He agreed with Lynch that patients with reflux hypersensitivity or functional heartburn are more likely to benefit from interventions other than a PPI, such as a neuromodulator.

But managing GERD in the clinic also requires making time to assess whether patients are taking PPI correctly and to counsel them on lifestyle modifications, he noted.

One of the current biggest challenges in GERD is how best to manage a patient who falls into the inconclusive range of not definitely normal or abnormal on pH testing, Kingsley told GI & Hepatology News. 

“As alluded to in this talk, MNBI and PSPW are emerging metrics, both of which require a pH-impedance study (as opposed to a wireless pH study),” he said. “Further elucidating the ideal application and cutoffs of these metrics may provide additional tools for best treating patients who fall into the “inconclusive” range with standard metrics.”

Lynch and Kingsley disclosed no financial conflicts of interest.
 

A version of this article appeared on Medscape.com . 

PHOENIX – For patients who suffer from persistent symptoms of gastroesophageal reflux disease (GERD) despite therapy, the first step is symptom evaluation, said Kristle L. Lynch, MD, in a presentation at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

Patients with persistent GERD who have cough and asthma, as well as those with hoarseness, globus, or other ear, nose, and throat concerns, may first undergo workup by other clinicians, said Lynch, who is a professor of clinical medicine and director of the Physiology and Motility Laboratory at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.

With these patients, “given the low pretest probability of an acid reflux source, it makes sense to bypass a trial of acid-suppressing medication if symptoms persist and instead move on to consideration of upper endoscopy,” she said.

“If negative for damage or sequelae of reflux, this test is often followed by advanced reflux testing and high-resolution manometry, to help diagnose the cause of reflux and swallowing problems,” she noted.

For patients with heartburn, regurgitation, or noncardiac chest pain (and no other concerning symptoms), moving to an empiric trial of antisecretory therapy before endoscopy can be reasonable, Lynch said. But if symptoms persist, an endoscopy should be done before any advanced pH testing.
 

Advanced pH Testing Options

Advanced reflux testing options for persistent GERD after an endoscopy include catheter-based pH-impedance testing and wireless pH testing, said Lynch.

“Wireless pH monitoring offers improved patient comfort by eliminating the need for a nasal catheter, allowing individuals to maintain normal daily activities and diet during testing,” Lynch told GI & Hepatology News.

“It also enables extended monitoring periods of up to 96 hours, enhancing the detection of intermittent acid reflux episodes,” she said. “However, unlike pH-impedance catheter-based testing, wireless pH measures only acid exposure and cannot identify nonacid reflux events.”

In addition, the wireless capsule may detach prematurely or cause mild chest discomfort, and its endoscopic placement adds procedural complexity with the need for anesthesia, as well as additional cost, she noted.

Catheter-based pH-impedance testing involves sedation-free catheter placement while the patient is awake, followed by monitoring for 24 hours, and involves assessment of bolus movement in tandem with pH measurements, Lynch said. The catheter monitors levels of acid refluxing into the esophagus and transmits this information to the smartphone-sized computer worn by the patient over the 24-hour period.

Unlike wireless testing, impedance testing allows for adjunctive measures of mean nocturnal baseline impedance (MNBI) and post-reflux swallow-induced peristaltic waves (PSPW), the latter of which is shown to predict response to proton pump inhibitor (PPI) therapy in patients with reflux.

Logistics include a concurrent manometry for the lower esophageal sphincter to optimize location, followed by a transnasal placement. Challenges associated with the catheter-based test include potential catheter migration and patient discomfort, she added.
 

Assessing pH Testing Results

After pH testing of either type, abnormal acid exposure time (AET) when the pH in the lower esophagus is greater than 6% supports a diagnosis of GERD; AET between 4% and 6% is considered borderline GERD; and AET less than 4% is considered normal and outside the bounds of pathologic reflux, as per the Lyon Consensus, Lynch explained.

Treatment for patients meeting the GERD criteria based on AET includes not only diet and lifestyle changes but also potential pharmacologics, including acid suppressants, alginates, gamma-aminobutyric acid agonists, and prokinetics. In some cases, anti-reflux surgery may be considered, such as magnetic sphincter augmentation, transoral incisionless fundoplication, or Roux-en-Y gastric bypass, Lynch said.

But not all heartburn in patients with persistent GERD is acid-related, she said. Functional heartburn and reflux hypersensitivity can be seen in these cases.

Patients not meeting the criteria for GERD on advanced pH testing and diagnosed with reflux hypersensitivity or functional heartburn may be treated with neuromodulators or nonpharmacologic therapies such as hypnosis, diaphragmatic breathing, cognitive-behavioral therapy, or acupuncture, said Lynch in her presentation.

Overall, “advanced pH testing should be assessed within the framework of other investigations and the patient as a whole,” she emphasized.
 

Challenges in the Clinic

One of the biggest mistakes while diagnosing a patient with persistent GERD symptoms despite PPI therapy is always assuming their symptoms are driven by ongoing pathologic acid exposure, said Michael Kingsley, MD, a gastroenterologist specializing in gastrointestinal motility disorders and a clinical assistant professor of medicine at the University of Pittsburgh, Pittsburgh, in an interview.

He agreed with Lynch that patients with reflux hypersensitivity or functional heartburn are more likely to benefit from interventions other than a PPI, such as a neuromodulator.

But managing GERD in the clinic also requires making time to assess whether patients are taking PPI correctly and to counsel them on lifestyle modifications, he noted.

One of the current biggest challenges in GERD is how best to manage a patient who falls into the inconclusive range of not definitely normal or abnormal on pH testing, Kingsley told GI & Hepatology News. 

“As alluded to in this talk, MNBI and PSPW are emerging metrics, both of which require a pH-impedance study (as opposed to a wireless pH study),” he said. “Further elucidating the ideal application and cutoffs of these metrics may provide additional tools for best treating patients who fall into the “inconclusive” range with standard metrics.”

Lynch and Kingsley disclosed no financial conflicts of interest.
 

A version of this article appeared on Medscape.com . 

Below are some selections from what I am reading in the AGA journals, highlighting clinically applicable and possibly practice-changing expert reviews and studies.

Endoscopy

Barkun AN, et al. Canadian Association of Gastroenterology Clinical Practice Guideline for the Endoscopic Management of Nonvariceal Nonpeptic Ulcer Upper Gastrointestinal Bleeding. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.04.041.

Kindel TL, et al. Multisociety Clinical Practice Guidance for the Safe Use of Glucagon-like Peptide-1 Receptor Agonists in the Perioperative Period. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2024.10.003.

Roy A, et al. Endohepatology: Evolving Indications, Challenges, Unmet Needs and Opportunities. Gastro Hep Advances. 2025 Oct. doi: 10.1016/j.gastha.2025.100838.

Esophagus

Wani S, et al. AGA Clinical Practice Guideline on Surveillance of Barrett’s Esophagus. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.09.012.

Reed CC, et al. Worsening Disease Severity as Measured by I-SEE Associates With Decreased Treatment Response to Topical Steroids in Eosinophilic Esophagitis Patients. Clin Gastroenterol Hepatol. 2025 Sep. doi: 10.1016/j.cgh.2025.01.015.

Kagzi Y, et al. Safety and Efficacy of Transoral Incisionless Fundoplication for Post–Esophageal Peroral Endoscopic Myotomy Gastroesophageal Reflux Disease With Esophagitis: A Meta-Analysis. Tech Innov Gastrointest Endosc. 2025 Oct. doi:10.1016/j.tige.2025.250953.

Stomach

Staller K, et al. AGA Clinical Practice Guideline on Management of Gastroparesis. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.08.004.

Colon

Bergman D, et al. Cholecystectomy Is a Risk Factor for Microscopic Colitis: A Nationwide Population-based Matched Case Control Study. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2024.12.032.

Liver

Younossi ZM, et al. Global Consensus Recommendations for Metabolic Dysfunction-Associated Steatotic Liver Disease and Steatohepatitis. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.02.044.

Kabelitz MA, et al. Early Occurrence of Hepatic Encephalopathy Following Transjugular Intrahepatic Portosystemic Shunt Insertion is Linked to Impaired Survival: A Multicenter Cohort Study. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2025.01.024.

Brar G, et al. Association of Cirrhosis Etiology with Outcomes After TIPS: A National Cohort Study. Gastro Hep Advances. 2025 Nov. doi: 10.1016/j.gastha.2025.100850.

IBD

Kucharzik T, et al. Role of Noninvasive Imaging in the Diagnosis and Management of Patients With Suspected and Established Inflammatory Bowel Disease. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.06.002.

Griffiths BJ, et al. Hypercoagulation After Hospital Discharge in Acute Severe Ulcerative Colitis: A Prospective Study. Clin Gastroenterol Hepatol. 2025 Sep. doi: 10.1016/j.cgh.2024.10.031.

Disorders of Gut-Brain Interaction

Trindade IA, et al. Implications of Shame for Patient-Reported Outcomes in Bowel Disorders of Gut-Brain Interaction. Gastroenterology. 2025 Aug. doi: 10.1053/j.gastro.2025.06.030. 

Salwen-Deremer JK, et al. A Practical Guide to Incorporating a Psychologist Into a Gastroenterology Practice. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.05.014.

Misc

Monahan K, et al. In Our Scope of Practice: Genetic Risk Assessment and Testing for Gastrointestinal Cancers and Polyposis in Gastroenterology. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.06.001.


Dr. Trieu is assistant professor of medicine, interventional endoscopy, in the Division of Gastroenterology at Washington University in St. Louis School of Medicine, Missouri.

Below are some selections from what I am reading in the AGA journals, highlighting clinically applicable and possibly practice-changing expert reviews and studies.

Endoscopy

Barkun AN, et al. Canadian Association of Gastroenterology Clinical Practice Guideline for the Endoscopic Management of Nonvariceal Nonpeptic Ulcer Upper Gastrointestinal Bleeding. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.04.041.

Kindel TL, et al. Multisociety Clinical Practice Guidance for the Safe Use of Glucagon-like Peptide-1 Receptor Agonists in the Perioperative Period. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2024.10.003.

Roy A, et al. Endohepatology: Evolving Indications, Challenges, Unmet Needs and Opportunities. Gastro Hep Advances. 2025 Oct. doi: 10.1016/j.gastha.2025.100838.

Esophagus

Wani S, et al. AGA Clinical Practice Guideline on Surveillance of Barrett’s Esophagus. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.09.012.

Reed CC, et al. Worsening Disease Severity as Measured by I-SEE Associates With Decreased Treatment Response to Topical Steroids in Eosinophilic Esophagitis Patients. Clin Gastroenterol Hepatol. 2025 Sep. doi: 10.1016/j.cgh.2025.01.015.

Kagzi Y, et al. Safety and Efficacy of Transoral Incisionless Fundoplication for Post–Esophageal Peroral Endoscopic Myotomy Gastroesophageal Reflux Disease With Esophagitis: A Meta-Analysis. Tech Innov Gastrointest Endosc. 2025 Oct. doi:10.1016/j.tige.2025.250953.

Stomach

Staller K, et al. AGA Clinical Practice Guideline on Management of Gastroparesis. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.08.004.

Colon

Bergman D, et al. Cholecystectomy Is a Risk Factor for Microscopic Colitis: A Nationwide Population-based Matched Case Control Study. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2024.12.032.

Liver

Younossi ZM, et al. Global Consensus Recommendations for Metabolic Dysfunction-Associated Steatotic Liver Disease and Steatohepatitis. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.02.044.

Kabelitz MA, et al. Early Occurrence of Hepatic Encephalopathy Following Transjugular Intrahepatic Portosystemic Shunt Insertion is Linked to Impaired Survival: A Multicenter Cohort Study. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2025.01.024.

Brar G, et al. Association of Cirrhosis Etiology with Outcomes After TIPS: A National Cohort Study. Gastro Hep Advances. 2025 Nov. doi: 10.1016/j.gastha.2025.100850.

IBD

Kucharzik T, et al. Role of Noninvasive Imaging in the Diagnosis and Management of Patients With Suspected and Established Inflammatory Bowel Disease. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.06.002.

Griffiths BJ, et al. Hypercoagulation After Hospital Discharge in Acute Severe Ulcerative Colitis: A Prospective Study. Clin Gastroenterol Hepatol. 2025 Sep. doi: 10.1016/j.cgh.2024.10.031.

Disorders of Gut-Brain Interaction

Trindade IA, et al. Implications of Shame for Patient-Reported Outcomes in Bowel Disorders of Gut-Brain Interaction. Gastroenterology. 2025 Aug. doi: 10.1053/j.gastro.2025.06.030. 

Salwen-Deremer JK, et al. A Practical Guide to Incorporating a Psychologist Into a Gastroenterology Practice. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.05.014.

Misc

Monahan K, et al. In Our Scope of Practice: Genetic Risk Assessment and Testing for Gastrointestinal Cancers and Polyposis in Gastroenterology. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.06.001.


Dr. Trieu is assistant professor of medicine, interventional endoscopy, in the Division of Gastroenterology at Washington University in St. Louis School of Medicine, Missouri.

Below are some selections from what I am reading in the AGA journals, highlighting clinically applicable and possibly practice-changing expert reviews and studies.

Endoscopy

Barkun AN, et al. Canadian Association of Gastroenterology Clinical Practice Guideline for the Endoscopic Management of Nonvariceal Nonpeptic Ulcer Upper Gastrointestinal Bleeding. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.04.041.

Kindel TL, et al. Multisociety Clinical Practice Guidance for the Safe Use of Glucagon-like Peptide-1 Receptor Agonists in the Perioperative Period. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2024.10.003.

Roy A, et al. Endohepatology: Evolving Indications, Challenges, Unmet Needs and Opportunities. Gastro Hep Advances. 2025 Oct. doi: 10.1016/j.gastha.2025.100838.

Esophagus

Wani S, et al. AGA Clinical Practice Guideline on Surveillance of Barrett’s Esophagus. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.09.012.

Reed CC, et al. Worsening Disease Severity as Measured by I-SEE Associates With Decreased Treatment Response to Topical Steroids in Eosinophilic Esophagitis Patients. Clin Gastroenterol Hepatol. 2025 Sep. doi: 10.1016/j.cgh.2025.01.015.

Kagzi Y, et al. Safety and Efficacy of Transoral Incisionless Fundoplication for Post–Esophageal Peroral Endoscopic Myotomy Gastroesophageal Reflux Disease With Esophagitis: A Meta-Analysis. Tech Innov Gastrointest Endosc. 2025 Oct. doi:10.1016/j.tige.2025.250953.

Stomach

Staller K, et al. AGA Clinical Practice Guideline on Management of Gastroparesis. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.08.004.

Colon

Bergman D, et al. Cholecystectomy Is a Risk Factor for Microscopic Colitis: A Nationwide Population-based Matched Case Control Study. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2024.12.032.

Liver

Younossi ZM, et al. Global Consensus Recommendations for Metabolic Dysfunction-Associated Steatotic Liver Disease and Steatohepatitis. Gastroenterology. 2025 Oct. doi: 10.1053/j.gastro.2025.02.044.

Kabelitz MA, et al. Early Occurrence of Hepatic Encephalopathy Following Transjugular Intrahepatic Portosystemic Shunt Insertion is Linked to Impaired Survival: A Multicenter Cohort Study. Clin Gastroenterol Hepatol. 2025 Nov. doi: 10.1016/j.cgh.2025.01.024.

Brar G, et al. Association of Cirrhosis Etiology with Outcomes After TIPS: A National Cohort Study. Gastro Hep Advances. 2025 Nov. doi: 10.1016/j.gastha.2025.100850.

IBD

Kucharzik T, et al. Role of Noninvasive Imaging in the Diagnosis and Management of Patients With Suspected and Established Inflammatory Bowel Disease. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.06.002.

Griffiths BJ, et al. Hypercoagulation After Hospital Discharge in Acute Severe Ulcerative Colitis: A Prospective Study. Clin Gastroenterol Hepatol. 2025 Sep. doi: 10.1016/j.cgh.2024.10.031.

Disorders of Gut-Brain Interaction

Trindade IA, et al. Implications of Shame for Patient-Reported Outcomes in Bowel Disorders of Gut-Brain Interaction. Gastroenterology. 2025 Aug. doi: 10.1053/j.gastro.2025.06.030. 

Salwen-Deremer JK, et al. A Practical Guide to Incorporating a Psychologist Into a Gastroenterology Practice. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.05.014.

Misc

Monahan K, et al. In Our Scope of Practice: Genetic Risk Assessment and Testing for Gastrointestinal Cancers and Polyposis in Gastroenterology. Gastroenterology. 2025 Nov. doi: 10.1053/j.gastro.2025.06.001.


Dr. Trieu is assistant professor of medicine, interventional endoscopy, in the Division of Gastroenterology at Washington University in St. Louis School of Medicine, Missouri.

A new drug currently known as NG101 reduced nausea and vomiting in patients with obesity using GLP-1s by 40% and 67%, respectively, based on data from a phase 2 trial presented at the Obesity Society’s Obesity Week 2025 in Atlanta.

Previous research published in JAMA Network Open showed a nearly 65% discontinuation rate for three GLP-1s (liraglutide, semaglutide, or tirzepatide) among adults with overweight or obesity and without type 2 diabetes. Gastrointestinal (GI) side effects topped the list of reasons for dropping the medications.

Given the impact of nausea and vomiting on discontinuation, there is an unmet need for therapies to manage GI symptoms, said Kimberley Cummings, PhD, of Neurogastrx, Inc., in her presentation.

In the new study, Cummings and colleagues randomly assigned 90 adults aged 18-55 years with overweight or obesity (defined as a BMI ranging from 22.0 to 35.0) to receive a single subcutaneous dose of semaglutide (0.5 mg) plus 5 days of NG101 at 20 mg twice daily, or a placebo.

NG101 is a peripherally acting D2 antagonist designed to reduce nausea and vomiting associated with GLP-1 use, Cummings said. NG101 targets the nausea center of the brain but is peripherally restricted to prevent central nervous system side effects, she explained.

Compared with placebo, NG101 significantly reduced the incidence of nausea and vomiting by 40% and 67%, respectively. Use of NG101 also was associated with a significant reduction in the duration of nausea and vomiting; GI events lasting longer than 1 day were reported in 22% and 51% of the NG101 patients and placebo patients, respectively.

In addition, participants who received NG101 reported a 70% decrease in nausea severity from baseline.

Overall, patients in the NG101 group also reported significantly fewer adverse events than those in the placebo group (74 vs 135), suggesting an improved safety profile when semaglutide is administered in conjunction with NG101, the researchers noted. No serious adverse events related to the study drug were reported in either group.

The findings were limited by several factors including the relatively small sample size. Additional research is needed with other GLP-1 agonists in larger populations with longer follow-up periods, Cummings said. However, the results suggest that NG101 was safe and effectively improved side effects associated with GLP-1 agonists.

“We know there are receptors for GLP-1 in the area postrema (nausea center of the brain), and that NG101 works on this area to reduce nausea and vomiting, so the study findings were not unexpected,” said Jim O’Mara, president and CEO of Neurogastrx, in an interview.

The study was a single-dose study designed to show proof of concept, and future studies would involve treating patients going through the recommended titration schedule for their GLP-1s, O’Mara said. However, NG101 offers an opportunity to keep more patients on GLP-1 therapy and help them reach their long-term therapeutic goals, he said.
 

Decrease Side Effects for Weight-Loss Success

“GI side effects are often the rate-limiting step in implementing an effective medication that patients want to take but may not be able to tolerate,” Sean Wharton, MD, PharmD, medical director of the Wharton Medical Clinic for Weight and Diabetes Management, Burlington, Ontario, Canada, said in an interview. “If we can decrease side effects, these medications could improve patients’ lives,” said Wharton, who was not involved in the study.

The improvement after a single dose of NG101 in patients receiving a single dose of semaglutide was impressive and in keeping with the mechanism of the drug action, said Wharton. “I was not surprised by the result but pleased that this single dose was shown to reduce the overall incidence of nausea and vomiting, the duration of nausea, the severity of nausea as rated by the study participants compared to placebo,” he said.

Ultimately, the clinical implications for NG101 are improved patient tolerance for GLP-1s and the ability to titrate and stay on them long term, incurring greater cardiometabolic benefit, Wharton told GI & Hepatology News.

The current trial was limited to GLP1-1s on the market; newer medications may have fewer side effects, Wharton noted. “In clinical practice, patients often decrease the medication or titrate slower, and this could be the comparator,” he added.

The study was funded by Neurogastrx.

Wharton disclosed serving as a consultant for Neurogastrx but not as an investigator on the current study. He also reported having disclosed research on various GLP-1 medications.
 

A version of this article appeared on Medscape.com.

A new drug currently known as NG101 reduced nausea and vomiting in patients with obesity using GLP-1s by 40% and 67%, respectively, based on data from a phase 2 trial presented at the Obesity Society’s Obesity Week 2025 in Atlanta.

Previous research published in JAMA Network Open showed a nearly 65% discontinuation rate for three GLP-1s (liraglutide, semaglutide, or tirzepatide) among adults with overweight or obesity and without type 2 diabetes. Gastrointestinal (GI) side effects topped the list of reasons for dropping the medications.

Given the impact of nausea and vomiting on discontinuation, there is an unmet need for therapies to manage GI symptoms, said Kimberley Cummings, PhD, of Neurogastrx, Inc., in her presentation.

In the new study, Cummings and colleagues randomly assigned 90 adults aged 18-55 years with overweight or obesity (defined as a BMI ranging from 22.0 to 35.0) to receive a single subcutaneous dose of semaglutide (0.5 mg) plus 5 days of NG101 at 20 mg twice daily, or a placebo.

NG101 is a peripherally acting D2 antagonist designed to reduce nausea and vomiting associated with GLP-1 use, Cummings said. NG101 targets the nausea center of the brain but is peripherally restricted to prevent central nervous system side effects, she explained.

Compared with placebo, NG101 significantly reduced the incidence of nausea and vomiting by 40% and 67%, respectively. Use of NG101 also was associated with a significant reduction in the duration of nausea and vomiting; GI events lasting longer than 1 day were reported in 22% and 51% of the NG101 patients and placebo patients, respectively.

In addition, participants who received NG101 reported a 70% decrease in nausea severity from baseline.

Overall, patients in the NG101 group also reported significantly fewer adverse events than those in the placebo group (74 vs 135), suggesting an improved safety profile when semaglutide is administered in conjunction with NG101, the researchers noted. No serious adverse events related to the study drug were reported in either group.

The findings were limited by several factors including the relatively small sample size. Additional research is needed with other GLP-1 agonists in larger populations with longer follow-up periods, Cummings said. However, the results suggest that NG101 was safe and effectively improved side effects associated with GLP-1 agonists.

“We know there are receptors for GLP-1 in the area postrema (nausea center of the brain), and that NG101 works on this area to reduce nausea and vomiting, so the study findings were not unexpected,” said Jim O’Mara, president and CEO of Neurogastrx, in an interview.

The study was a single-dose study designed to show proof of concept, and future studies would involve treating patients going through the recommended titration schedule for their GLP-1s, O’Mara said. However, NG101 offers an opportunity to keep more patients on GLP-1 therapy and help them reach their long-term therapeutic goals, he said.
 

Decrease Side Effects for Weight-Loss Success

“GI side effects are often the rate-limiting step in implementing an effective medication that patients want to take but may not be able to tolerate,” Sean Wharton, MD, PharmD, medical director of the Wharton Medical Clinic for Weight and Diabetes Management, Burlington, Ontario, Canada, said in an interview. “If we can decrease side effects, these medications could improve patients’ lives,” said Wharton, who was not involved in the study.

The improvement after a single dose of NG101 in patients receiving a single dose of semaglutide was impressive and in keeping with the mechanism of the drug action, said Wharton. “I was not surprised by the result but pleased that this single dose was shown to reduce the overall incidence of nausea and vomiting, the duration of nausea, the severity of nausea as rated by the study participants compared to placebo,” he said.

Ultimately, the clinical implications for NG101 are improved patient tolerance for GLP-1s and the ability to titrate and stay on them long term, incurring greater cardiometabolic benefit, Wharton told GI & Hepatology News.

The current trial was limited to GLP1-1s on the market; newer medications may have fewer side effects, Wharton noted. “In clinical practice, patients often decrease the medication or titrate slower, and this could be the comparator,” he added.

The study was funded by Neurogastrx.

Wharton disclosed serving as a consultant for Neurogastrx but not as an investigator on the current study. He also reported having disclosed research on various GLP-1 medications.
 

A version of this article appeared on Medscape.com.

A new drug currently known as NG101 reduced nausea and vomiting in patients with obesity using GLP-1s by 40% and 67%, respectively, based on data from a phase 2 trial presented at the Obesity Society’s Obesity Week 2025 in Atlanta.

Previous research published in JAMA Network Open showed a nearly 65% discontinuation rate for three GLP-1s (liraglutide, semaglutide, or tirzepatide) among adults with overweight or obesity and without type 2 diabetes. Gastrointestinal (GI) side effects topped the list of reasons for dropping the medications.

Given the impact of nausea and vomiting on discontinuation, there is an unmet need for therapies to manage GI symptoms, said Kimberley Cummings, PhD, of Neurogastrx, Inc., in her presentation.

In the new study, Cummings and colleagues randomly assigned 90 adults aged 18-55 years with overweight or obesity (defined as a BMI ranging from 22.0 to 35.0) to receive a single subcutaneous dose of semaglutide (0.5 mg) plus 5 days of NG101 at 20 mg twice daily, or a placebo.

NG101 is a peripherally acting D2 antagonist designed to reduce nausea and vomiting associated with GLP-1 use, Cummings said. NG101 targets the nausea center of the brain but is peripherally restricted to prevent central nervous system side effects, she explained.

Compared with placebo, NG101 significantly reduced the incidence of nausea and vomiting by 40% and 67%, respectively. Use of NG101 also was associated with a significant reduction in the duration of nausea and vomiting; GI events lasting longer than 1 day were reported in 22% and 51% of the NG101 patients and placebo patients, respectively.

In addition, participants who received NG101 reported a 70% decrease in nausea severity from baseline.

Overall, patients in the NG101 group also reported significantly fewer adverse events than those in the placebo group (74 vs 135), suggesting an improved safety profile when semaglutide is administered in conjunction with NG101, the researchers noted. No serious adverse events related to the study drug were reported in either group.

The findings were limited by several factors including the relatively small sample size. Additional research is needed with other GLP-1 agonists in larger populations with longer follow-up periods, Cummings said. However, the results suggest that NG101 was safe and effectively improved side effects associated with GLP-1 agonists.

“We know there are receptors for GLP-1 in the area postrema (nausea center of the brain), and that NG101 works on this area to reduce nausea and vomiting, so the study findings were not unexpected,” said Jim O’Mara, president and CEO of Neurogastrx, in an interview.

The study was a single-dose study designed to show proof of concept, and future studies would involve treating patients going through the recommended titration schedule for their GLP-1s, O’Mara said. However, NG101 offers an opportunity to keep more patients on GLP-1 therapy and help them reach their long-term therapeutic goals, he said.
 

Decrease Side Effects for Weight-Loss Success

“GI side effects are often the rate-limiting step in implementing an effective medication that patients want to take but may not be able to tolerate,” Sean Wharton, MD, PharmD, medical director of the Wharton Medical Clinic for Weight and Diabetes Management, Burlington, Ontario, Canada, said in an interview. “If we can decrease side effects, these medications could improve patients’ lives,” said Wharton, who was not involved in the study.

The improvement after a single dose of NG101 in patients receiving a single dose of semaglutide was impressive and in keeping with the mechanism of the drug action, said Wharton. “I was not surprised by the result but pleased that this single dose was shown to reduce the overall incidence of nausea and vomiting, the duration of nausea, the severity of nausea as rated by the study participants compared to placebo,” he said.

Ultimately, the clinical implications for NG101 are improved patient tolerance for GLP-1s and the ability to titrate and stay on them long term, incurring greater cardiometabolic benefit, Wharton told GI & Hepatology News.

The current trial was limited to GLP1-1s on the market; newer medications may have fewer side effects, Wharton noted. “In clinical practice, patients often decrease the medication or titrate slower, and this could be the comparator,” he added.

The study was funded by Neurogastrx.

Wharton disclosed serving as a consultant for Neurogastrx but not as an investigator on the current study. He also reported having disclosed research on various GLP-1 medications.
 

A version of this article appeared on Medscape.com.

Accurate neoplasia detection in patients with Barrett’s esophagus (BE) involves high-quality endoscopy, adequate biopsy sampling, careful examination, and appropriate recognition of neoplastic lesions, said Prateek Sharma, MD, in a presentation on the management of BE at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

However, clinicians often make mistakes such as failing to remove debris such as saliva and bile from the esophagus prior to assessing a patient, said Sharma, professor of medicine and the Elaine Blaylock Endowed Professor at the University of Kansas School of Medicine and the Cancer Center, Kansas City, Kansas.

More than 90% of neoplasias in patients with BE are found on an index endoscopy or within 6 months, as shown by Sharma and his colleagues in a systematic review, which highlights the importance of a high-quality index endoscopy, he told meeting attendees.

To improve the index endoscopy, Sharma developed a new algorithm called “CLEAN.”

The algorithm is composed of five steps, he said, the first of which is Clear: clear the esophagus of debris, including saliva and bile. Adequate prep is essential to detecting clinically significant lesions in patients with BE, he explained. In a study published in 2024, Sharma and colleagues found adequate cleanliness of the upper gastrointestinal tract was associated with a significantly higher detection rate of clinically significant lesions.

The second step of the algorithm is Learn: pay attention to BE inspection time and learn slow withdrawal strategies.

It’s important not to shortchange inspection time, Sharma emphasized. He cited a previous study in which the percentage of patients with BE who had high-grade dysplasia or esophageal adenocarcinoma during a surveillance endoscopy was 15% with inspection times of 2 minutes or less but jumped to 69% with inspection times of 7 minutes or more.

The third step of CLEAN is Endoscope: conduct a high-definition white-light endoscopy, which should be coupled with the fourth step, Acquire: acquire education on BE-related neoplasia, to learn how to recognize neoplastic lesions, he stressed.

The final step of the algorithm is Neoplasia detection rate (NDR): follow a quality metric to measure NDR.

The algorithm emphasizes a comprehensive approach in conjunction with resection of visible lesions followed by ablation for complete eradication, Sharma told GI & Hepatology News.
 

After Identification: What’s Next?

If lesions are identified, the next step is resection and/or ablation, Sharma said.

“Resection is typically used for visible lesions, nodules, or masses, while ablation is used to treat the remaining underlying Barrett tissue,” he told GI & Hepatology News. “A combination of both is often necessary to fully treat advanced cases, such as when a nodule is resected and the surrounding area is subsequently ablated.”

“It’s important to understand why we need to resect,” he said.

“Resection removes the lesion” and “provides more accurate histopathology reading and staging of how deep the lesion is,” he explained. Options for resection of cancerous or precancerous lesions in patients with BE include endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).

The treatment algorithm for BE continues to evolve, Sharma said in his presentation. Currently, evidence supports EMR for most cases, but ESD is based on factors including lesion size ≥ 25-30 mm and potential submucosal invasion, he said.

He cited a study of 1000 adults with early BE who were managed with EMR that showed a 96% curative response after 5 years. Similarly, a review of ESD for early BE neoplasia including 501 patients showed a 75% curative response rate overall and a 93% en bloc resection rate, he noted.
 

Ablation

In terms of ablation, radiofrequency ablation, hybrid argon plasma coagulation, and the multifocal cryoballoon procedure have shown significant effectiveness, Sharma said.

In a 2020 multicenter, prospective study of 120 adult patients with BE, 76% achieved complete eradication of dysplasia, and 72% achieved complete eradication of intestinal metaplasia. As for safety, data from nine European centers including 154 patients who underwent ablation after resection had an adverse event rate of 6%, said Sharma.
 

In the Clinic

“It is sometimes difficult to detect subtle nodularity and irregularity that would benefit more from resection therapy/EMR rather than ablation,” said Gyanprakash A. Ketwaroo, MD, associate professor of medicine (digestive diseases) at Yale University, New Haven, Connecticut.

“Lesions can be obscured by esophagitis, peristalsis, or the shape of the [gastroesophageal] GE junction,” he noted. Therefore, careful scope cleaning and inspection with high-definition white light and narrow band imaging are important, he said. “Using a cap on the scope to better distend or manipulate the gastroesophageal junction also helps identify obscured lesions,” he added.

“Any acronym or approach that reminds us to slow down, and examine carefully, is welcome,” Ketwaroo told GI & Hepatology News. The CLEAN algorithm provides a useful summary of some of the key steps all clinicians should incorporate into approaching BE and could be useful for teaching trainees, he added.

Sharma disclosed serving as a consultant for the Olympus Corporation and Exact Sciences and receiving grant support from Fujifilm, Erbe Medical, and Braintree Pharmaceuticals.
 

A version of this article appeared on Medscape.com.

Accurate neoplasia detection in patients with Barrett’s esophagus (BE) involves high-quality endoscopy, adequate biopsy sampling, careful examination, and appropriate recognition of neoplastic lesions, said Prateek Sharma, MD, in a presentation on the management of BE at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

However, clinicians often make mistakes such as failing to remove debris such as saliva and bile from the esophagus prior to assessing a patient, said Sharma, professor of medicine and the Elaine Blaylock Endowed Professor at the University of Kansas School of Medicine and the Cancer Center, Kansas City, Kansas.

More than 90% of neoplasias in patients with BE are found on an index endoscopy or within 6 months, as shown by Sharma and his colleagues in a systematic review, which highlights the importance of a high-quality index endoscopy, he told meeting attendees.

To improve the index endoscopy, Sharma developed a new algorithm called “CLEAN.”

The algorithm is composed of five steps, he said, the first of which is Clear: clear the esophagus of debris, including saliva and bile. Adequate prep is essential to detecting clinically significant lesions in patients with BE, he explained. In a study published in 2024, Sharma and colleagues found adequate cleanliness of the upper gastrointestinal tract was associated with a significantly higher detection rate of clinically significant lesions.

The second step of the algorithm is Learn: pay attention to BE inspection time and learn slow withdrawal strategies.

It’s important not to shortchange inspection time, Sharma emphasized. He cited a previous study in which the percentage of patients with BE who had high-grade dysplasia or esophageal adenocarcinoma during a surveillance endoscopy was 15% with inspection times of 2 minutes or less but jumped to 69% with inspection times of 7 minutes or more.

The third step of CLEAN is Endoscope: conduct a high-definition white-light endoscopy, which should be coupled with the fourth step, Acquire: acquire education on BE-related neoplasia, to learn how to recognize neoplastic lesions, he stressed.

The final step of the algorithm is Neoplasia detection rate (NDR): follow a quality metric to measure NDR.

The algorithm emphasizes a comprehensive approach in conjunction with resection of visible lesions followed by ablation for complete eradication, Sharma told GI & Hepatology News.
 

After Identification: What’s Next?

If lesions are identified, the next step is resection and/or ablation, Sharma said.

“Resection is typically used for visible lesions, nodules, or masses, while ablation is used to treat the remaining underlying Barrett tissue,” he told GI & Hepatology News. “A combination of both is often necessary to fully treat advanced cases, such as when a nodule is resected and the surrounding area is subsequently ablated.”

“It’s important to understand why we need to resect,” he said.

“Resection removes the lesion” and “provides more accurate histopathology reading and staging of how deep the lesion is,” he explained. Options for resection of cancerous or precancerous lesions in patients with BE include endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).

The treatment algorithm for BE continues to evolve, Sharma said in his presentation. Currently, evidence supports EMR for most cases, but ESD is based on factors including lesion size ≥ 25-30 mm and potential submucosal invasion, he said.

He cited a study of 1000 adults with early BE who were managed with EMR that showed a 96% curative response after 5 years. Similarly, a review of ESD for early BE neoplasia including 501 patients showed a 75% curative response rate overall and a 93% en bloc resection rate, he noted.
 

Ablation

In terms of ablation, radiofrequency ablation, hybrid argon plasma coagulation, and the multifocal cryoballoon procedure have shown significant effectiveness, Sharma said.

In a 2020 multicenter, prospective study of 120 adult patients with BE, 76% achieved complete eradication of dysplasia, and 72% achieved complete eradication of intestinal metaplasia. As for safety, data from nine European centers including 154 patients who underwent ablation after resection had an adverse event rate of 6%, said Sharma.
 

In the Clinic

“It is sometimes difficult to detect subtle nodularity and irregularity that would benefit more from resection therapy/EMR rather than ablation,” said Gyanprakash A. Ketwaroo, MD, associate professor of medicine (digestive diseases) at Yale University, New Haven, Connecticut.

“Lesions can be obscured by esophagitis, peristalsis, or the shape of the [gastroesophageal] GE junction,” he noted. Therefore, careful scope cleaning and inspection with high-definition white light and narrow band imaging are important, he said. “Using a cap on the scope to better distend or manipulate the gastroesophageal junction also helps identify obscured lesions,” he added.

“Any acronym or approach that reminds us to slow down, and examine carefully, is welcome,” Ketwaroo told GI & Hepatology News. The CLEAN algorithm provides a useful summary of some of the key steps all clinicians should incorporate into approaching BE and could be useful for teaching trainees, he added.

Sharma disclosed serving as a consultant for the Olympus Corporation and Exact Sciences and receiving grant support from Fujifilm, Erbe Medical, and Braintree Pharmaceuticals.
 

A version of this article appeared on Medscape.com.

Accurate neoplasia detection in patients with Barrett’s esophagus (BE) involves high-quality endoscopy, adequate biopsy sampling, careful examination, and appropriate recognition of neoplastic lesions, said Prateek Sharma, MD, in a presentation on the management of BE at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

However, clinicians often make mistakes such as failing to remove debris such as saliva and bile from the esophagus prior to assessing a patient, said Sharma, professor of medicine and the Elaine Blaylock Endowed Professor at the University of Kansas School of Medicine and the Cancer Center, Kansas City, Kansas.

More than 90% of neoplasias in patients with BE are found on an index endoscopy or within 6 months, as shown by Sharma and his colleagues in a systematic review, which highlights the importance of a high-quality index endoscopy, he told meeting attendees.

To improve the index endoscopy, Sharma developed a new algorithm called “CLEAN.”

The algorithm is composed of five steps, he said, the first of which is Clear: clear the esophagus of debris, including saliva and bile. Adequate prep is essential to detecting clinically significant lesions in patients with BE, he explained. In a study published in 2024, Sharma and colleagues found adequate cleanliness of the upper gastrointestinal tract was associated with a significantly higher detection rate of clinically significant lesions.

The second step of the algorithm is Learn: pay attention to BE inspection time and learn slow withdrawal strategies.

It’s important not to shortchange inspection time, Sharma emphasized. He cited a previous study in which the percentage of patients with BE who had high-grade dysplasia or esophageal adenocarcinoma during a surveillance endoscopy was 15% with inspection times of 2 minutes or less but jumped to 69% with inspection times of 7 minutes or more.

The third step of CLEAN is Endoscope: conduct a high-definition white-light endoscopy, which should be coupled with the fourth step, Acquire: acquire education on BE-related neoplasia, to learn how to recognize neoplastic lesions, he stressed.

The final step of the algorithm is Neoplasia detection rate (NDR): follow a quality metric to measure NDR.

The algorithm emphasizes a comprehensive approach in conjunction with resection of visible lesions followed by ablation for complete eradication, Sharma told GI & Hepatology News.
 

After Identification: What’s Next?

If lesions are identified, the next step is resection and/or ablation, Sharma said.

“Resection is typically used for visible lesions, nodules, or masses, while ablation is used to treat the remaining underlying Barrett tissue,” he told GI & Hepatology News. “A combination of both is often necessary to fully treat advanced cases, such as when a nodule is resected and the surrounding area is subsequently ablated.”

“It’s important to understand why we need to resect,” he said.

“Resection removes the lesion” and “provides more accurate histopathology reading and staging of how deep the lesion is,” he explained. Options for resection of cancerous or precancerous lesions in patients with BE include endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).

The treatment algorithm for BE continues to evolve, Sharma said in his presentation. Currently, evidence supports EMR for most cases, but ESD is based on factors including lesion size ≥ 25-30 mm and potential submucosal invasion, he said.

He cited a study of 1000 adults with early BE who were managed with EMR that showed a 96% curative response after 5 years. Similarly, a review of ESD for early BE neoplasia including 501 patients showed a 75% curative response rate overall and a 93% en bloc resection rate, he noted.
 

Ablation

In terms of ablation, radiofrequency ablation, hybrid argon plasma coagulation, and the multifocal cryoballoon procedure have shown significant effectiveness, Sharma said.

In a 2020 multicenter, prospective study of 120 adult patients with BE, 76% achieved complete eradication of dysplasia, and 72% achieved complete eradication of intestinal metaplasia. As for safety, data from nine European centers including 154 patients who underwent ablation after resection had an adverse event rate of 6%, said Sharma.
 

In the Clinic

“It is sometimes difficult to detect subtle nodularity and irregularity that would benefit more from resection therapy/EMR rather than ablation,” said Gyanprakash A. Ketwaroo, MD, associate professor of medicine (digestive diseases) at Yale University, New Haven, Connecticut.

“Lesions can be obscured by esophagitis, peristalsis, or the shape of the [gastroesophageal] GE junction,” he noted. Therefore, careful scope cleaning and inspection with high-definition white light and narrow band imaging are important, he said. “Using a cap on the scope to better distend or manipulate the gastroesophageal junction also helps identify obscured lesions,” he added.

“Any acronym or approach that reminds us to slow down, and examine carefully, is welcome,” Ketwaroo told GI & Hepatology News. The CLEAN algorithm provides a useful summary of some of the key steps all clinicians should incorporate into approaching BE and could be useful for teaching trainees, he added.

Sharma disclosed serving as a consultant for the Olympus Corporation and Exact Sciences and receiving grant support from Fujifilm, Erbe Medical, and Braintree Pharmaceuticals.
 

A version of this article appeared on Medscape.com.

The more than 2 million women US veterans are the fastest-growing military population. While research into women veterans has traditionally lagged, more recently studies have begun to focus on their needs impacts of combat and service on women. These studies have found that women veterans preferred tailored solutions focused on women veterans.

A November 2025 study is one of the first to examine the impact of combat on women veterans. It found that those in combat roles had higher levels of depression, posttraumatic stress disorder (PTSD), dissociation, and overall poorer health compared with civilians and noncombat women military personnel. Previous research had found that women veterans had higher rates of lifetime and past-year PTSD (13.4%) compared with female civilians (8.0%), male veterans (7.7%), and male civilians (3.4%). A 2020 US Department of Veterans (VA) study of 4,928,638 men and 448,455 women similarly found that women had nearly twice the rates of depression and anxiety compared with men.

For many veterans, mental health issues may develop or be exacerbated in their return to civilian life. That transition can be especially confusing and isolating for women veterans, according to a 2024 study: “They neither fit in the military due to gendered relations centered on masculinity, or civilian life where they are largely misunderstood as ‘veterans.’ This ‘no woman’s land’ is poorly understood.” Few programs for transitioning veterans have been found effective for women veterans because they’ve been developed for a largely male veteran population. That includes mental health support programs.

Some women may prefer women-only groups, and even that choice may be dependent on their background, service history, socioeconomic level, and other factors. They may feel more comfortable in women-only groups if they’ve experienced MST. Others who have served in combat may choose mixed-gender programs. One study found that some women benefited from being in a mixed-gender group because it enabled them to work on difficulties with men in a safe environment. Other research has found that women veterans with substance use disorders are reluctant to seek help alongside men in the same facilities. 

Accessing care may be especially challenging for rural women veterans. However, separate facilities and women-only groups are not always available, particularly in rural areas where there may be very few women veterans. And even if they are available, rural women are often up against barriers that urban women do not face, such as having to travel long distances to get care. Clinicians also may be hard to find in rural areas. Some participants in a 2025 study were hampered not only by a lack of female practitioners, but practitioners who were well trained to understand and treat the unique needs of female veterans: “[It’s] incredibly difficult to find a mental health practitioner that understands a veteran’s unique experience as a woman,” a participant said.

The more than 2 million women US veterans are the fastest-growing military population. While research into women veterans has traditionally lagged, more recently studies have begun to focus on their needs impacts of combat and service on women. These studies have found that women veterans preferred tailored solutions focused on women veterans.

A November 2025 study is one of the first to examine the impact of combat on women veterans. It found that those in combat roles had higher levels of depression, posttraumatic stress disorder (PTSD), dissociation, and overall poorer health compared with civilians and noncombat women military personnel. Previous research had found that women veterans had higher rates of lifetime and past-year PTSD (13.4%) compared with female civilians (8.0%), male veterans (7.7%), and male civilians (3.4%). A 2020 US Department of Veterans (VA) study of 4,928,638 men and 448,455 women similarly found that women had nearly twice the rates of depression and anxiety compared with men.

For many veterans, mental health issues may develop or be exacerbated in their return to civilian life. That transition can be especially confusing and isolating for women veterans, according to a 2024 study: “They neither fit in the military due to gendered relations centered on masculinity, or civilian life where they are largely misunderstood as ‘veterans.’ This ‘no woman’s land’ is poorly understood.” Few programs for transitioning veterans have been found effective for women veterans because they’ve been developed for a largely male veteran population. That includes mental health support programs.

Some women may prefer women-only groups, and even that choice may be dependent on their background, service history, socioeconomic level, and other factors. They may feel more comfortable in women-only groups if they’ve experienced MST. Others who have served in combat may choose mixed-gender programs. One study found that some women benefited from being in a mixed-gender group because it enabled them to work on difficulties with men in a safe environment. Other research has found that women veterans with substance use disorders are reluctant to seek help alongside men in the same facilities. 

Accessing care may be especially challenging for rural women veterans. However, separate facilities and women-only groups are not always available, particularly in rural areas where there may be very few women veterans. And even if they are available, rural women are often up against barriers that urban women do not face, such as having to travel long distances to get care. Clinicians also may be hard to find in rural areas. Some participants in a 2025 study were hampered not only by a lack of female practitioners, but practitioners who were well trained to understand and treat the unique needs of female veterans: “[It’s] incredibly difficult to find a mental health practitioner that understands a veteran’s unique experience as a woman,” a participant said.

The more than 2 million women US veterans are the fastest-growing military population. While research into women veterans has traditionally lagged, more recently studies have begun to focus on their needs impacts of combat and service on women. These studies have found that women veterans preferred tailored solutions focused on women veterans.

A November 2025 study is one of the first to examine the impact of combat on women veterans. It found that those in combat roles had higher levels of depression, posttraumatic stress disorder (PTSD), dissociation, and overall poorer health compared with civilians and noncombat women military personnel. Previous research had found that women veterans had higher rates of lifetime and past-year PTSD (13.4%) compared with female civilians (8.0%), male veterans (7.7%), and male civilians (3.4%). A 2020 US Department of Veterans (VA) study of 4,928,638 men and 448,455 women similarly found that women had nearly twice the rates of depression and anxiety compared with men.

For many veterans, mental health issues may develop or be exacerbated in their return to civilian life. That transition can be especially confusing and isolating for women veterans, according to a 2024 study: “They neither fit in the military due to gendered relations centered on masculinity, or civilian life where they are largely misunderstood as ‘veterans.’ This ‘no woman’s land’ is poorly understood.” Few programs for transitioning veterans have been found effective for women veterans because they’ve been developed for a largely male veteran population. That includes mental health support programs.

Some women may prefer women-only groups, and even that choice may be dependent on their background, service history, socioeconomic level, and other factors. They may feel more comfortable in women-only groups if they’ve experienced MST. Others who have served in combat may choose mixed-gender programs. One study found that some women benefited from being in a mixed-gender group because it enabled them to work on difficulties with men in a safe environment. Other research has found that women veterans with substance use disorders are reluctant to seek help alongside men in the same facilities. 

Accessing care may be especially challenging for rural women veterans. However, separate facilities and women-only groups are not always available, particularly in rural areas where there may be very few women veterans. And even if they are available, rural women are often up against barriers that urban women do not face, such as having to travel long distances to get care. Clinicians also may be hard to find in rural areas. Some participants in a 2025 study were hampered not only by a lack of female practitioners, but practitioners who were well trained to understand and treat the unique needs of female veterans: “[It’s] incredibly difficult to find a mental health practitioner that understands a veteran’s unique experience as a woman,” a participant said.