RecruitingPhase 2NCT07267260

Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial


Sponsor

King Edward Medical University

Enrollment

154 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if the medicine vonoprazan can help prevent ulcers that may develop after endoscopic variceal band ligation (EVBL) in adults with liver cirrhosis. These ulcers sometimes cause pain or delayed bleeding after the procedure. The study will also look at how well vonoprazan is tolerated and if it improves comfort after the procedure. The main questions this study will answer are: Does vonoprazan lower the number and severity of ulcers found on endoscopy after EVBL? Does vonoprazan reduce swallowing pain or chest discomfort compared with placebo? Is vonoprazan safe and well tolerated in people with liver cirrhosis? Researchers will compare vonoprazan 20 mg once daily with a placebo (a look-alike tablet that contains no active medicine) to see if vonoprazan works better to prevent these ulcers. Participants will: Take vonoprazan or placebo by mouth once daily for 14 days after EVBL. Return for a follow-up endoscopy about two weeks later to check for ulcers. Report any symptoms such as pain, nausea, or swallowing difficulty during the study. Adults aged 18 to 75 years with liver cirrhosis who undergo EVBL will be invited to join. Participants will be randomly assigned to one of two groups, and neither they nor the study doctors will know which treatment they receive (double-blind design). The study will take place at Mayo Hospital, Lahore, Pakistan, over about six months. By comparing vonoprazan to placebo, researchers hope to find a better way to protect the esophagus and stomach after EVBL, reduce post-procedure pain, and support faster recovery in people with liver cirrhosis.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether vonoprazan — a newer type of acid-suppressing medication — can help prevent painful ulcers that sometimes form in the esophagus (food pipe) after a procedure called endoscopic variceal band ligation (EVBL), which is used to treat enlarged, at-risk blood vessels in people with liver cirrhosis. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with liver cirrhosis - You have esophageal varices (enlarged veins in the food pipe) that require treatment with band ligation - You can communicate in English or Urdu - You agree to follow-up procedures including a return endoscopy **You may NOT be eligible if...** - You have previously had stomach or esophageal surgery - You are allergic to vonoprazan or its components - You are pregnant or breastfeeding - You are currently experiencing active bleeding in your digestive tract - You are critically ill (in intensive care, on a ventilator, or severely confused) - You have upper digestive tract cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVonoprazan 20 mg

Vonoprazan is a potassium-competitive acid blocker (P-CAB) that provides strong and sustained suppression of gastric acid secretion. In this study, participants will receive vonoprazan 20 mg by mouth once daily for 14 days after endoscopic variceal band ligation (EVBL). The tablets will be taken with water, preferably before breakfast. This dose and duration are based on prior clinical experience in acid-related disorders. The aim is to determine whether vonoprazan prevents the formation of ulcers and reduces post-procedure pain compared with placebo.

OTHERPlacebo

Participants in the placebo group will receive a look-alike oral tablet with no active medicine, once daily for 14 days after EVBL. The placebo will be identical in color, size, and packaging to the Vonoprazan tablet to maintain blinding. This comparator will help determine whether Vonoprazan provides any true benefit in preventing ulcers and improving symptoms beyond standard post-procedure care.


Locations(1)

King Edward Medical University/Mayo Hospital

Lahore, Punjab Province, Pakistan

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NCT07267260


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