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

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.

Study Overview

• Status: Recruiting
• Conditions: Cirrhoses, Liver
• Intervention / Treatment: Drug: Vonoprazan 20 mg; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Muhammad R Tariq, MBBS,FCPS; Phone Number: +923337692728; Email: ibneislam190@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Recruiting
      • King Edward Medical University/Mayo Hospital
      • Contact: Muhammad Sheikh; Phone Number: 03219994005; Email: dr.usheikh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vonoprazan 20 mg after EVBL; Participants in this arm will receive vonoprazan 20 mg orally once daily for 14 days following endoscopic variceal band ligation (EVBL). Vonoprazan is a potassium-competitive acid blocker that provides strong and sustained suppression of gastric acid. The aim is to test whether vonoprazan can help prevent the formation of ulcers that sometimes develop after EVBL and to improve symptoms such as pain or difficulty swallowing. Participants will continue their usual medical care for liver disease. Study staff, participants, and investigators will all remain blinded to treatment allocation until data analysis is complete.	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 ulcers and reduces post-procedure pain compared with placebo.; Other Names: TAK-438; Potassium-competitive acid blocker
Placebo Comparator: Placebo after EVBL; Participants in this arm will receive a placebo tablet orally once daily for 14 days following endoscopic variceal band ligation (EVBL). The placebo tablet will look identical to the Vonoprazan tablet but contains no active medicine. This group serves as a comparison to determine whether Vonoprazan is more effective than placebo in preventing post-procedural ulcers and reducing symptoms such as swallowing discomfort or chest pain. Participants will receive standard medical care for liver disease and will undergo the same follow-up and assessments as the experimental group.	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.; Other Names: Inactive tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Post-Endoscopic Variceal Band Ligation (EVBL) Ulcers	The proportion of participants who develop visible post-banding ulcers detected on follow-up endoscopy. Ulcers will be assessed using the Lanza Score for gastric mucosal injury, which grades the number and severity of ulcers from 0 (no injury) to 4 (severe injury). A lower Lanza score indicates less mucosal injury. The outcome compares the rate and severity of ulcers between the vonoprazan and placebo groups.	At follow-up endoscopy, 14 ± 1 days after EVBL.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dysphagia, Odynophagia, and Retrosternal Pain Scores on Visual Analog Scale (VAS)	Change in symptom intensity for swallowing pain (odynophagia), difficulty swallowing (dysphagia), and chest discomfort (retrosternal pain), measured using a 100 mm Visual Analog Scale (VAS) where 0 = no pain and 100 = worst possible pain. The change from baseline to day 14 will be calculated. A ≥ 20% reduction in VAS score from baseline will be considered clinically significant.	Baseline and 14 ± 1 days after EVBL.

Collaborators and Investigators

• Sponsor: King Edward Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): December 16, 2025
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): March 5, 2026

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Estimated): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cirrhosis; Portal hypertension; Vonoprazan; Esophageal varices; Potassium-competitive acid blocker; Endoscopic variceal band ligation; Post-procedure ulcer; Double-blind randomized controlled trial
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Pathological Conditions, Signs and Symptoms; Fibrosis; Hypertension, Portal; Esophageal and Gastric Varices; 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
• Other Study ID Numbers: 640/RC/KEMU Dated: 28/08/25; 640/RC/KEMU (Other Identifier: IRB King Edward Medical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared publicly because this is a single-center academic study conducted at Mayo Hospital, Lahore, with a limited sample size and locally collected data. De-identified summary data and statistical analyses may be made available upon reasonable request to the principal investigator after publication of study results, in accordance with institutional and ethical committee policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No