Clinical trial NCT02709421: Risk Factors of Post-ERCP Pancreatitis in Patients Receiving Rectal Indomethacin
Official title: Risk Factors Related to Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis in High-risk Patients Who Underwent ERCP and Received Prophylactic Rectal Indomethacin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: post-Endoscopic Retrograde cholangiopancreatography pancreatitis
Risk factors
Indomethacin
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 790
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent ERCP and received administration of rectal indomethacin.

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.


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

Primary outcomes:
measure: Overall PEP rate
timeFrame: 1 year
Secondary outcomes:
measure: The rate of moderate-severe pancreatitis
timeFrame: 1 year
measure: Overall ERCP-related complication rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Department of gastroenterology,Chinese PLA 174 Hospital
state: Fujian
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Disgestive Diseases.The Fourth Military University
name: Yanglin Pan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Kang X, Zheng L, Zeng W, Yang S, Sun H, Zhang R, Wang X, Wang B, Tao Q, Yao S, Chen J, Pan Y, Guo X. Risk Factors for Post-ERCP Pancreatitis in High-Risk Patients Receiving Post-procedure Rectal Indomethacin. J Gastrointest Surg. 2018 Nov;22(11):1903-1910. doi: 10.1007/s11605-018-3864-0. Epub 2018 Jul 6.