Risk Factors Related to Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis in High-risk Patients Who Underwent ERCP and Received Prophylactic Rectal Indomethacin

Air Force Military Medical University, China3 sites in 1 country790 target enrollmentFebruary 2016

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Air Force Military Medical University, China
Enrollment: 790
Locations: 3
Primary Endpoint: Overall PEP rate
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis (PEP)remains the most frequent adverse event of ERCP. Rectal indomethacin, as one kind of classic NSAIDs, has been proved to be effective in reducing the incidence of PEP. It has been widely used to prevent PEP in patients, especially those with potentially high risks of PEP. However, rectal indomethacin can not completely eradicate the occurrence of PEP. The rate of PEP in patients receiving indomethacin ranges from 3.2% to 9.2%. The risk factors of PEP in patients receiving rectal indomethacin remains unclear. The aim of the study was to identify potential risk factors in high-risk patients whose received administration of prophylactic rectal indomethacin after ERCP.

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

September 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Air Force Military Medical University, China

Responsible Party

Principal Investigator

Yanglin Pan

Associated professor

Air Force Military Medical University, China

Eligibility Criteria

Inclusion Criteria

•Undergoing diagnostic or interventional ERCP
•Receiving administration of rectal indomethacin(100mg) after ERCP
•High risk patients determined at the discretions of endoscopists

Exclusion Criteria

•Dose other than 100mg
•Acute pancreatitis within 3 days before ERCP
•Average risk patients at the discretions of endoscopists
•Using NSAIDs within 7 days before ERCP
•Without cannulation attempts
•Administration of rectal indomethacin before or during ERCP

Outcomes

Primary Outcomes

Overall PEP rate

Time Frame: 1 year

PEP was defined if patients experienced abdominal pain for more than 24h after procedure, accompanying with amylase or lipase ≥ 3 times equal to the upper limit of normal value.