Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 154
- Locations
- 1
- Primary Endpoint
- Incidence of Post-Endoscopic Variceal Band Ligation (EVBL) Ulcers
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Vonoprazan 20 mg (Drug)
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.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Incidence of Post-Endoscopic Variceal Band Ligation (EVBL) Ulcers
Time Frame: At follow-up endoscopy, 14 ± 1 days after EVBL.
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.
Secondary Outcomes
- Change in Dysphagia, Odynophagia, and Retrosternal Pain Scores on Visual Analog Scale (VAS)(Baseline and 14 ± 1 days after EVBL.)
Investigators
Rizwan Tariq Neuro
Principal Investigator
King Edward Medical University