Marginal Ulcer
Conditions
Keywords
marginal ulcer, bariatric surgery, gastric bypass, open capsule
Brief 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).
Detailed description
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.
Interventions
DRUGOmeprazole 40 milligrams
Subjects will be randomized to treatment with either open-capsule or intact-capsule omeprazole to assess effect on ulcer healing times. If interim analysis illustrates significantly improved healing in the open-capsule group, the control (intact-capsule) arm will be allowed to cross-over to open-capsule and be followed until confirmed ulcer healing.
Sponsors
Stephen Firkins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
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.
Intervention model description
prospective single-blinded randomized control trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects diagnosed with marginal ulceration post-gastric bypass on upper endoscopy
Exclusion criteria
* Refusal to start PPI medication OR current open-capsule PPI use at the time of diagnosis of the marginal ulcer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer healing | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer healing time | On average, 3 months to 12 months | Time to ulcer healing, defined as (date of ulcer healing) - (date of ulcer diagnosis) |
| pH of gastric pouch | Upon initial enrollment endoscopy | pH of the gastric pouch fluid will be obtained during initial endoscopy and tested with litmus paper. pH data will be compared between the two treatment arms. |
Countries
United States
Contacts
CONTACTStephen Firkins, MD
PRINCIPAL_INVESTIGATORStephen Firkins, MD
The Cleveland Clinic
Outcome results
None listed