Vonoprazan Efficacy to Prevent Post Variceal Band Ligation Ulcer

Alexandria University

Status and phase: Completed; Phase 3

Conditions: Ulcer Hemorrhage; Portal Hypertension; Variceal Hemorrhage

Treatments: Drug: Pantoprazole 40mg; Other: Placebo; Drug: Vonoprazan fumarate (Vonaspire)

Study type: Interventional

Funder types: Other

Identifiers

NCT05227833

0305413

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with liver cirrhosis 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,
• Hepatocellular carcinoma
• Portal vein thrombosis
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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284 participants in 3 patient groups, including a placebo group

Vonoprazan

Experimental group

Description:

Vonoprazan (vonaspire 20 mg), tablets, one tablet per day before breakfast for 14 days starting from the day of band ligation.

Treatment:

Drug: Vonoprazan fumarate (Vonaspire)

Pantoprazole

Active Comparator group

Description:

Pantoprazole (Controloc 40 mg OR Antopral 40 mg OR Perloc 40 mg), tablets, one tablet per day before breakfast for 14 days, starting from the day of band ligation.

Treatment:

Drug: Pantoprazole 40mg

Placebo

Placebo Comparator group

Description:

No acid suppressive medications will be described.

Treatment:

Other: Placebo