Vonoprazan Efficacy to Prevent Post Variceal Band Ligation Ulcer
Condition: Portal Hypertension; Variceal Hemorrhage; Ulcer Hemorrhage
MeSH terms: Hypertension, Portal; Hypertension; Ulcer; Hemorrhage
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Vonoprazan fumarate (Vonaspire); Pantoprazole 40mg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Patients assigned to Vonoprazan (vonaspire) tablets will receive a daily dose of 20 mg before breakfast starting from the first day of band ligation.; 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.; No Intervention
Other intervention name(s): Vonoprazan; Pantoprazole Sodium
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The enrolled participants after having an endoscopic variceal ligation session will be randomly allocated to one of three interventions (for 14 days):
Vonoprazan 20 mg once before breakfast OR Pantoprazole 40 mg before breakfast OR Placebo (no treatment) at a 1:1 ratio.
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Portal Hypertension; Post-ligation ulcer; Vonoprazan; Pantoprazole; Variceal bleeding