Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Routine Rectal Indomethacin Given Before Procedure Reduced Overall Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Multi-center, Single-blinded, Randomized Controlled Trial

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.

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;