CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,600 enrolled
Drug / intervention
Pre-ERCP rectal Indomethacin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02002650
NCT02002650N/ACompleted

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

Air Force Military Medical University, China·interventional·Posted Dec 6, 2013·Updated Jun 29, 2016

In Brief

A clinical study evaluating Pre-ERCP rectal Indomethacin and Post-operational Rectal Indomethacin for Post-ERCP Acute Pancreatitis. Completed, enrolled 2,600 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 6, 2013
Enrollment StartDec 1, 2013
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.6 years ago

Interventions

Pre-ERCP rectal Indomethacindrug

Rectal Indomethacin was administrated within 30min before ERCP in all patients.

Post-operational Rectal Indomethacindrug

Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.