Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis
Status:
Completed
Trial end date:
2018-10-01
Target enrollment:
Participant gender:
Summary
It is now established that indomethacin, a non-steroidal anti-inflammatory drug, at a dose of
100 mg, is effective in reducing the frequency and severity of pancreatitis (inflammation of
the pancreas) after endoscopic retrograde cholangiopancreatography (ERCP) in high risk
patients. However, the optimal dose required is not known. The purpose of this study is to
determine whether a dose of 200 mg, administered as rectal suppositories, is more effective
than the standard dose of 100 mg. An ERCP procedure is a scope procedure where a lighted tube
with a camera is passed down the patient's throat and allows for evaluation of the bile duct
and/or pancreatic duct. The most common side effect of this procedure is post-ERCP
pancreatitis, or swelling of the pancreas. Some patients are at higher risk for this
complication than others. Our hypothesis is to compare the efficacy of these two dose
regimens (100 mg vs 200 mg) of prophylactic rectally-administered indomethacin on the
frequency and severity of post-ERCP pancreatitis in high-risk patients.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Indiana University
Collaborators:
American College of Gastroenterology Aurora Health Care Beth Israel Deaconess Medical Center Medical University of South Carolina University of Michigan University of Texas