Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Air Force Military Medical University of People's Liberation Army

Status

Completed

Conditions

Post-ERCP Acute Pancreatitis

Treatments

Drug: Pre-ERCP rectal Indomethacin

Drug: Post-operational Rectal Indomethacin

Study type

Interventional

Funder types

Other

Identifiers

NCT02002650

20131106-7 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

2,600 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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;