Diclofenac for Prevention of Post-ERC Pancreatitis

Study Overview
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Brief Summary
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The study aims at assessing the effectiveness of Diclofenac for prevention of post-ERCP pancreatitis. It will be undertaken embedded in the Swedish national register for Gallstone surgery and ERCP (GallRiks). Patients are randomised to Diclofenac prior to the ERCP or no prophylaxis. GallRiks is used to identify which patients fulfill the eligibility criteria and which patients develop pancreatitis after the ERCP.

Detailed Description
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Endoscopic Retrograde Cholangiopancreatography (ERCP) is a procedure commonly performed for diagnosing changes in the bile ducts or managing outflow obstruction. Although ERCP may in most cases be performed safely, there is a risk of developing acute pancreatitis following the procedure. The risk has been estimated to 5-10%, with an increased risk in women, younger patients and in case the cannulation is difficult. Phospholipase 2 is crucial in the pathogenesis of acute pancreatitis. As Diclofenac is a potent inhibitor of Phospholipase 2, it has been suggested that it may be used for prevention of post-ERCP pancreatitis. There is some evidence for the effectiveness of Diclofenac, but more studies are needed to confirm that it reduces the risk of post-ERCP pancreatitis. In order to test whether Diclofenac reduces the risk for post-ERCP pancreatitis, a register-based randomized controlled study is planned. The study will be conducted embedded in the Swedish Register for Gallstone Surgery and ERCP (GallRiks). GallRiks includes data corresponding to the eligibility criteria as well as outcome measures. GallRiks will also be used to record which patients have been screened for inclusion. Patients who meet the eligibility criteria are invited to the study. If they accept inclusion, they are randomized to 100 mg Diclofenac prior to the ERCP or np prophylaxis. No blinding is done. The aim is to include 1000 patients. When 500 patients have been included, an interim analysis will be performed, comparing the incidence of pancreatitis and mortality in the two groups. A retrospective review of the patient records will be performed for those who develop pancreatitis.

Official Title
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Diclofenac for Prevention of Post-ERC Pancreatitis

Conditions
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Common Bile Duct Diseases

Intervention / Treatment
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* Drug: Diclofenac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing ERCP Exclusion Criteria: Decision to perform ERCP taken intraoperatively Intolerance/allergy against NSAID Patients taking NSAID daily Severe cardiac fail (ASA>4) Kidney failure (GFR<30 ml/min) Coagulation disorder History of peptic ulcer bleeding History of abdominoperineal resection Pregnancy Patients who do not understand Swedish

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Open label randomised controlled trial of Diclofenac as prophylaxis versus no prophylaxis for prevention of post-ERCP pancreatitis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diclofenac<br>100 mg Diclofenac rectally prior to the ERCP | Drug: Diclofenac<br>* Diclofenac rectally given before the ERCP to prevent pancreatitis<br>|
| No Intervention: No prophylaxis<br>No prophylaxis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-ERCP pancreatitis | Acute pancreatitis recorded in GallRiks by responsible endoscopist or surgeon. According to GallRiks criteria pancreatitis includes elevated amylase and abdominal pain of an intensity that hospital stay is warranted. | Within 30 days post-ERCP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reactions | Kidney failure, gastroduodenal ulcer or gastrointestinal bleeding | Within 30 days post-ERCP | 
| Mortality | Death within 30 days after ERCP | Within 30 days post-ERCP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Retrograde Cholangiopancreatography, Pancreatitis, Diclofenac