OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers

Summary

The goal of this clinical trial is to identify the most effective way to take acid-blocking medications to treat stomach ulcers in patients who have undergone gastric bypass surgery. The main questions it aims to answer are: * is taking an acid-blocking medication by opening the capsule and only taking the contents of the capsule (open-capsule) more or less effective than taking the capsule as a whole (intact-capsule) for treating ulcers in patients who have a history of gastric bypass surgery? * does taking the open versus intact medication decrease the number of procedures and complications from untreated ulcers? Participants with ulcers will be instructed to take acid-blocking medications (called proton-pump inhibitors) either by opening the capsule and taking only the contents or by taking the capsule whole. These medications are the gold standard for treatment of stomach ulcers. Participants will be asked to undergo an upper endoscopy (EGD) every 3 months to monitor the healing of the ulcers. Researchers will compare how quickly the ulcers heal depending on which way the medications are taken (opened up or as a whole).

Timeline

Start

2023-03-14

Primary completion

2027-03-23

Completion

2027-03-23

Publications

• Background English WJ, DeMaria EJ, Hutter MM, Kothari SN, Mattar SG, Brethauer SA, Morton JM. American Society for Metabolic and Bariatric Surgery 2018 estimate of metabolic and bariatric procedures performed in the United States. Surg Obes Relat Dis. 2020 Apr;16(4):457-463. doi: 10.1016/j.soard.2019.12.022. Epub 2020 Jan 3.
• Background Coblijn UK, Goucham AB, Lagarde SM, Kuiken SD, van Wagensveld BA. Development of ulcer disease after Roux-en-Y gastric bypass, incidence, risk factors, and patient presentation: a systematic review. Obes Surg. 2014 Feb;24(2):299-309. doi: 10.1007/s11695-013-1118-5.
• Background Ribeiro-Parenti L, Arapis K, Chosidow D, Marmuse JP. Comparison of marginal ulcer rates between antecolic and retrocolic laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2015 Feb;25(2):215-21. doi: 10.1007/s11695-014-1392-x.
• Background Pyke O, Yang J, Cohn T, Yin D, Docimo S, Talamini MA, Bates AT, Pryor A, Spaniolas K. Marginal ulcer continues to be a major source of morbidity over time following gastric bypass. Surg Endosc. 2019 Oct;33(10):3451-3456. doi: 10.1007/s00464-018-06618-5. Epub 2018 Dec 12.
• Background Di Palma A, Liu B, Maeda A, Anvari M, Jackson T, Okrainec A. Marginal ulceration following Roux-en-Y gastric bypass: risk factors for ulcer development, recurrence and need for revisional surgery. Surg Endosc. 2021 May;35(5):2347-2353. doi: 10.1007/s00464-020-07650-0. Epub 2020 May 18.
• Background Tansel A, Graham DY. New Insight Into an Effective Treatment of Marginal Ulceration After Roux-en-Y Gastric Bypass. Clin Gastroenterol Hepatol. 2017 Apr;15(4):501-503. doi: 10.1016/j.cgh.2016.12.025. Epub 2017 Jan 3. No abstract available.
• Background Schulman AR, Chan WW, Devery A, Ryan MB, Thompson CC. Opened Proton Pump Inhibitor Capsules Reduce Time to Healing Compared With Intact Capsules for Marginal Ulceration Following Roux-en-Y Gastric Bypass. Clin Gastroenterol Hepatol. 2017 Apr;15(4):494-500.e1. doi: 10.1016/j.cgh.2016.10.015. Epub 2016 Oct 20.

Drugs

Indications