Vonoprazan Efficacy to Prevent Post Variceal Band Ligation Ulcer

• Status: Not yet recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Endoscopic variceal ligation (EVL) is used to control and prevent variceal bleeding in patients with liver cirrhosis, but it can be complicated by bleeding from post-EVL ulcers. the current study aims at evaluating the potential benefit of different acid-suppressive therapies in prevention of post band ligation ulcer/bleeding. We will include 234 patients with cirrhotic portal hypertension undergoing endoscopic band ligation. Patients will be randomly allocated into one group of acid suppressive therapy (Vonoprazan or pantoprazole) versus placebo for 14 days. Re-endoscopy will be done after 2 weeks of treatment to assess the healing of post ligation ulcers. Any form of upper gastrointestinal bleeding will be documented.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexandria University
• Treatments: Pantoprazole

Criteria

Inclusion Criteria:

• Patients with liver cirrhosis Child Pugh A or B/9 with portal hypertension who are eligible for endoscopic band ligation (Bleeding varices, or non-bleeder but with risk signs) according to BAVINO VII guidelines

• Patients who completed the study protocol.

• Eligible participants who are willing to comply with the study protocol and provide written consent.

Exclusion Criteria:

• Endoscopically confirmed pre-existing esophageal ulcers

• Ongoing therapy with any anti-acid agent,

• Previous anti-flux procedure,

• Barrett's esophagus,

• History of liver transplantation,

• Pregnancy, and allergy or past adverse reaction to acid-suppressive therapy

• Estimated glomerular filtration rate < 60 mL/min/1.73 meter square.