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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709421
• Other study ID #: 20160224-2
• Status: Completed
• Phase: N/A
• First received: February 29, 2016
• Last updated: September 1, 2016
• Start date: February 2016
• Est. completion date: September 2016

Study information

• Verified date: June 2016
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 790
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Healthy
• Pancreatitis

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi
China	Department of gastroenterology,Chinese PLA 174 Hospital	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Dumonceau JM, Andriulli A, Elmunzer BJ, Mariani A, Meister T, Deviere J, Marek T, Baron TH, Hassan C, Testoni PA, Kapral C; European Society of Gastrointestinal Endoscopy. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy. 2014 Sep;46(9):799-815. doi: 10.1055/s-0034-1377875. Epub 2014 Aug 22. — View Citation

Yaghoobi M, Rolland S, Waschke KA, McNabb-Baltar J, Martel M, Bijarchi R, Szego P, Barkun AN. Meta-analysis: rectal indomethacin for the prevention of post-ERCP pancreatitis. Aliment Pharmacol Ther. 2013 Nov;38(9):995-1001. doi: 10.1111/apt.12488. Epub 2013 Sep 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall PEP rate	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.	1 year	No
Secondary	The rate of moderate-severe pancreatitis		1 year	No
Secondary	Overall ERCP-related complication rate		1 year	No