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

Completed

• Conditions: Healthy

• Registration Number: NCT02709421
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-29
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-16
• Status Verified: 2016-06
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 790

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall PEP rate	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 Outcome Measures

Name	Time	Method
The rate of moderate-severe pancreatitis	1 year
Overall ERCP-related complication rate	1 year

Trial Locations

Locations (3)

Department of gastroenterology,Chinese PLA 174 Hospital; 🇨🇳 Xiamen, Fujian, China

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China