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Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

NCT02002650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2600

Last updated 2016-06-29

Study results available
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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

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.

Sponsors & Collaborators

  • Air Force Military Medical University, China

    lead OTHER

Principal Investigators

  • Yanglin Pan, M.D. · Xijing Hospital of Digestive Diseases.The Fourth Military Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02002650 on ClinicalTrials.gov