Conditions: Post-ERCP Acute Pancreatitis
Keywords: Indomethacin, pancreatitis, ERCP
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2600
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Pre-ERCP rectal Indomethacin in all patients. arm 2: Post-ERCP rectal Indomethacin in high-risk patients.

Interventions: intervention 1: Pre-ERCP rectal Indomethacin intervention 2: Post-operational Rectal Indomethacin
Intervention descriptions: intervention 1: Rectal Indomethacin was administrated within 30min before ERCP in all patients. intervention 2: Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.

Protocol document: