OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers After Bariatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Ulcer healing
研究概览
简要总结
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).
详细描述
Marginal ulcers (ulcers formed at the surgery site between the stomach and the intestines) are a common complication of bariatric surgery, ranging in frequency from 0.6-25% of patients. Furthermore, roughly 17% of patients with marginal ulcers require repeat procedures or surgery for severe complications such as bleeding, perforation, stricture, and fistulas.
Proton pump inhibitors (PPIs), which act by block acid secretion from the stomach, are the gold standard for treatment of ulcers. There is limited data showing that opening the PPI capsule and taking only the contents greatly improves healing of marginal ulcers after gastric bypass surgery. This is likely due to the much smaller stomach, faster passage through the stomach and decreased ability of the intact PPI medication to be broken down and absorbed.
This would be the first clinical trial to confirm whether this is true, which would support all patients who get ulcers after gastric bypass surgery to be treated with open-capsule PPI medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Endoscopists diagnosing and surveying healing of marginal ulcers will be blinded to the subject's treatment arm. A single, unmasked provider will be responsible for randomizing and prescribing either open- or intact-capsule PPI after subjects are enrolled in the study. This unmasked provider will not take part in diagnosis, monitoring or assessment of ulcer healing, or in data analysis.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with marginal ulceration post-gastric bypass on upper endoscopy
排除标准
- •Refusal to start PPI medication OR current open-capsule PPI use at the time of diagnosis of the marginal ulcer
研究组 & 干预措施
Open-capsule
Subjects in this arm will be treated with omeprazole 40 milligrams twice daily (or alternative medication if not covered by the subject's insurance) taken as an open-capsule until confirmed ulcer healing.
干预措施: Omeprazole 40 milligrams (Drug)
Intact-capsule
Subjects in this arm will be treated with omeprazole 40 milligrams twice daily (or alternative medication if not covered by the subject's insurance) taken as an intact-capsule until confirmed ulcer healing or potential cross-over.
干预措施: Omeprazole 40 milligrams (Drug)
结局指标
主要结局
Ulcer healing
时间窗: On average, 3 months to 12 months
Rate of ulcer healing in each treatment arm, defined as resolution of previously-seen ulcer on upper endoscopy
次要结局
- Ulcer healing time(On average, 3 months to 12 months)
- pH of gastric pouch(Upon initial enrollment endoscopy)
研究者
Stephen Firkins
Co-Director of Bariatric Endoscopy
The Cleveland Clinic