Indomethacin for Preventing Pancreatitis After ERCP
This study is looking at whether a medication called indomethacin can help prevent pancreatitis (inflammation of the pancreas) after a procedure called ERCP (endoscopic retrograde cholangiopancreatography). You might be eligible if you are 18 or older, are scheduled for a routine biliary ERCP, and have had a previous biliary sphincterotomy (a cut in the bile duct). Participants will receive a single rectal suppository of indomethacin 100 mg right before their ERCP. The main goal is to see how many people develop pancreatitis within 30 days after the ERCP. This trial aims to clarify if indomethacin helps in this specific group of patients.
- Study design
- This is a randomized study, meaning participants are assigned by chance to receive the indomethacin. The study plans to enroll 860 participants.
- What's involved
- You would receive a single rectal suppository of indomethacin immediately before your ERCP procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will check for pancreatitis within 30 days after your ERCP procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Indomethacin for Biliary ERCP Patients
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Michael Larsen, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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What this trial measures
- Incidence of Post-ERCP PancreatitisWithin 30 days following ERCP Procedure
The incidence of post-ERCP pancreatitis (PEP) following biliary ERCP, defined using standard consensus criteria: new or worsened abdominal pain consistent with acute pancreatitis, elevation of serum amylase or lipase to at least three times the upper limit of normal within 24 hours after ERCP, and hospitalization or prolongation of planned admission attributable to pancreatitis. The outcome will be compared between participants receiving prophylactic rectal indomethacin and those receiving placebo.