Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vonoprazan 20 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Cirrhoses, Liver. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Vonoprazan 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 ulce - Other Placebo
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.
Primary outcome measures
- Incidence of Post-Endoscopic Variceal Band Ligation (EVBL) Ulcers [Time frame: At follow-up endoscopy, 14 ± 1 days after EVBL.]
Secondary outcome measures (1)
- Change in Dysphagia, Odynophagia, and Retrosternal Pain Scores on Visual Analog Scale (VAS) [Time frame: Baseline and 14 ± 1 days after EVBL.]
Eligibility criteria
Inclusion criteria
- Adults aged 18 to 75 years (male or female)
- Diagnosis of liver cirrhosis confirmed by clinical, biochemical, or imaging findings.
- Presence of documented esophageal varices requiring endoscopic variceal band ligation (EVBL).
- Able and willing to provide written informed consent in English or Urdu.
- Willing to comply with study procedures, including taking study medication and attending follow-up endoscopy.
Exclusion criteria
- History of gastric or esophageal surgery
- Allergy or contraindication to vonoprazan or study drug components
- Pregnant or lactating women
- Individuals who are non-cooperative or unable to understand local languages
- Critically ill patients, including:
ICU admission Requirement for mechanical ventilation GCS < 10
- Active gastrointestinal bleeding at the time of enrollment
- Malignancy of the upper gastrointestinal tract
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Pakistan · 1 center
- King Edward Medical University/Mayo Hospital — Lahore
Identifiers
NCT: NCT07267260 · 640/RC/KEMU Dated: 28/08/25 · 640/RC/KEMU