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

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Healthy

Study type: Observational

Funder types: Other

Identifiers

NCT02709421

20160224-2

Details and patient eligibility

About

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.

Enrollment: 790 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

790 participants in 1 patient group

Indomethacin Group

Description:

All the patients with high risks of PEP received administration of one single dose of 100mg rectal indomethacin after ERCP. Patients were considered high risk of PEP if they met one of the following criteria: clinical suspicion of sphincter of Oddi dysfunction, a history of PEP, pancreatic sphincterotomy, precut sphincterotomy, ≥8 cannulation attempts, cannulation time≥10 minutes; pneumatic dilatation of an intact biliary sphincter, ≥3 inadvertent pancreatic duct cannulation, opacification of pancreatic acini, or the acquisition of a cytologic specimen from the pancreatic duct with the use of a brush or forceps.