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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Indomethacin Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of moderate-severe pancreatitis |  | 1 year | 
| Overall ERCP-related complication rate |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-Endoscopic Retrograde cholangiopancreatography pancreatitis, Risk factors, Indomethacin