Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Air Force Military Medical University, China; Fourth Military Medical University
• Treatments: Indomethacin

Criteria

Inclusion Criteria:

• Patients undergoing diagnostic or therapeutic ERCP.

Exclusion Criteria:

• Unwillingness or inability to consent for the study;

• Age < 18 years old;

• Intrauterine pregnancy;

• Breastfeeding mother;

• Standard contraindications to ERCP;

• Allergy to NSAIDs;

• Received NSAIDs in prior 7 days;

• Renal failure (Cr >1.4mg/dl=120umol/l);

• Active or recurrent (within 4 weeks) gastrointestinal hemorrhage;

• Acute pancreatitis within 72 hours;

• Known pancreatic head mass;

• Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram;

• ERCP for biliary stent removal or exchange without anticipated pancreatogram;

• Known active cardiovascular or cerebrovascular disease.

• Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;