Vonoprazan to prevent ulcers after endoscopic variceal band ligation
Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial
This trial tests whether taking vonoprazan 20 mg once daily for 14 days after variceal band ligation can reduce ulcers and swallowing pain in adults with liver cirrhosis compared with a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | King Edward Medical University Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07267260 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled Phase 2 trial enrolling adults with confirmed liver cirrhosis who require endoscopic variceal band ligation (EVBL). Participants are assigned to receive vonoprazan 20 mg once daily or a matching placebo for 14 days after EVBL, with a follow-up endoscopy about two weeks later to check for ulcers. Outcomes include the number and severity of post-EVBL ulcers, patient-reported swallowing pain or chest discomfort, and safety/tolerability in patients with cirrhosis. The trial aims to determine if acid suppression with vonoprazan improves comfort and reduces complications after the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–75 with confirmed liver cirrhosis who are undergoing EVBL and can provide informed consent and attend follow-up endoscopy.
Not a fit: Patients who are pregnant or lactating, critically ill (e.g., ICU, mechanical ventilation, GCS < 10), actively bleeding at enrollment, with prior gastric/esophageal surgery, or allergic to vonoprazan are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, vonoprazan could lower the incidence and severity of post-EVBL ulcers and reduce pain or delayed bleeding after the procedure.
How similar studies have performed: Vonoprazan is effective for acid-related conditions and reduces gastric acidity, but using it specifically to prevent post-EVBL ulcers is a novel application with limited direct prior trial evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lahore, Punjab Province
- King Edward Medical University/Mayo Hospital — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Study coordinator: Muhammad R Tariq, MBBS,FCPS
- Email: ibneislam190@gmail.com
- Phone: +923337692728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.