Risk Factors of Post-ERCP Pancreatitis in Patients Receiving Rectal Indomethacin

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.

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Key information

Conditions

Healthy

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of gastroenterology,Chinese PLA 174 Hospital, Xiamen, Fujian, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Secondary outcomes

The rate of moderate-severe pancreatitis

Time frame: 1 year
Overall ERCP-related complication rate

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Mar 16, 2016
Registry last updated: Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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