NCT02002650

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,600 (actual)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-ERCP Acute Pancreatitis

Interventions

Type	Name	Description
DRUG	Pre-ERCP rectal Indomethacin	Rectal Indomethacin was administrated within 30min before ERCP in all patients.
DRUG	Post-operational Rectal Indomethacin	Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2013-12-06
• Last updated: 2016-06-29
• Results posted: 2016-05-27

Locations

6 sites across 1 country: China