drugset / Trial / NCT05227833
Vonoprazan Efficacy to Prevent Post Variceal Band Ligation Ulcer
Phase 3
Completed
284 enrolled
Alexandria University
Alexandria University Hospital, Alexandria, Alexandria Governorate, Egypt · collab
RandomizedParallel-groupSingle-blindPrevention
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.
Timeline
- Start
- 2022-02-15
- Primary completion
- 2022-11-15
- Completion
- 2022-11-15
Publications
- Results Kang SH, Yim HJ, Kim SY, Suh SJ, Hyun JJ, Jung SW, Jung YK, Koo JS, Lee SW. Proton Pump Inhibitor Therapy Is Associated With Reduction of Early Bleeding Risk After Prophylactic Endoscopic Variceal Band Ligation: A Retrospective Cohort Study. Medicine (Baltimore). 2016 Feb;95(8):e2903. doi: 10.1097/MD.0000000000002903.
- Results Lin L, Cui B, Deng Y, Jiang X, Liu W, Sun C. The Efficacy of Proton Pump Inhibitor in Cirrhotics with Variceal Bleeding: A Systemic Review and Meta-Analysis. Digestion. 2021;102(2):117-127. doi: 10.1159/000505059. Epub 2020 Feb 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pantoprazole | Other / unclassified | 40 mg | Oral |
| Subject | Vonoprazan | Other / unclassified | 20 mg | Oral |