NCT05227833

Vonoprazan Efficacy to Prevent Post Variceal Band Ligation Ulcer

Vonoprazan vs. Pantoprazole in the Prevention of Post Endoscopic Band Ligation Ulcer/Bleeding in Portal Hypertensive Patients: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with portal hypertension who have esophageal varices usually are treated by endoscopic band ligation according to the international guidelines to prevent variceal bleeding. After band ligation, patients may suffer from post-ligation ulcer and/or bleeding. In the current study, we evaluate the effectiveness of Vonoprazan, a novel potassium-competitive acid suppressor agent, in prevention of post-ligation ulcer and /or bleeding. We also will compare this drug with the proton-pump inhibitor Pantoprazole and with placebo. We aim to enroll 234 patients who will undergo elective endoscopic variceal ligation according to the BAVINO VII guidelines will be randomly assigned to one of three arms : Vonoprazan 20 mg once daily, Pantoprazole 40 mg once daily, or Placebo (no treatment). The treatment will start from the day of band ligation and will continue for 14 days. After that, a follow up endoscopy will be done to evaluate the site of band ligation. Any ulcer at the ligation site will be documented and its size will be measured. Also, any attack of bleeding from the ulcer site (if present) will be documented. A comparison between the three arms will be done in terms of effectiveness, and bleeding rates. Safety assessment: The safety assessment will include all patients who will receive at least 1 dose of their assigned treatment. The safety endpoints will include treatment related adverse effects (TRAEs) grouped by Medical Dictionary for Regulatory Activities version 19.1, system organ class and preferred term, and changes from baseline in an abbreviated physical examination including vital signs, signs of liver cell deterioration, and mean change in laboratory measures including hemogram, liver aminotransferases, serum urea and creatinine, liver function test.

Conditions

• Portal Hypertension
• Variceal Hemorrhage
• Ulcer Hemorrhage

Interventions

Type	Name	Description
DRUG	Vonoprazan fumarate (Vonaspire)	Patients assigned to Vonoprazan (vonaspire) tablets will receive a daily dose of 20 mg before breakfast starting from the first day of band ligation.
DRUG	Pantoprazole 40mg	Patients assigned to Pantoprazole tablets (Controloc OR Antopral OR Perloc) will receive a daily dose of 40 mg before breakfast starting from the first day of band ligation.
OTHER	Placebo	No Intervention

Timeline

• Start date: 2022-02-15
• Primary completion: 2022-11-15
• Completion: 2022-11-15
• First posted: 2022-02-07
• Last updated: 2024-08-30

Locations

1 site across 1 country: Egypt