Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Study Overview
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Brief Summary
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Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a standard method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.

Official Title
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Routine Rectal Indomethacin Given Before Procedure Reduced Overall Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Multi-center, Single-blinded, Randomized Controlled Trial

Conditions
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Post-ERCP Acute Pancreatitis

Intervention / Treatment
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* Drug: Pre-ERCP rectal Indomethacin
* Drug: Post-operational Rectal Indomethacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing diagnostic or therapeutic ERCP. Exclusion Criteria: Unwillingness or inability to consent for the study; Age < 18 years old; Intrauterine pregnancy; Breastfeeding mother; Standard contraindications to ERCP; Allergy to NSAIDs; Received NSAIDs in prior 7 days; Renal failure (Cr >1.4mg/dl=120umol/l); Active or recurrent (within 4 weeks) gastrointestinal hemorrhage; Acute pancreatitis within 72 hours; Known pancreatic head mass; Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram; ERCP for biliary stent removal or exchange without anticipated pancreatogram; Known active cardiovascular or cerebrovascular disease. Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;

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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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-ERCP group<br>Pre-ERCP rectal Indomethacin in all patients. | Drug: Pre-ERCP rectal Indomethacin<br>* Rectal Indomethacin was administrated within 30min before ERCP in all patients.<br>|
| Active Comparator: Post-ERCP group<br>Post-ERCP rectal Indomethacin in high-risk patients. | Drug: Post-operational Rectal Indomethacin<br>* Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-ERCP Pancreatitis | Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate-to-severe Pancreatitis | Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery). | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indomethacin, pancreatitis, ERCP