Post ERCP Pancreatitis Prevention in Average Risk Patients

Study Overview
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Brief Summary
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Diclophenac potassium and ceftazidime are commercially available drugs that are used in various clinical situations. They are safe and known for years. Diclophenac potassium and Ceftazidime have been used in some studies for the prophylaxis and treatment of pancreatitis and Post-ERCP Pancreatitis (PEP). Diclophenac potassium, together with indometacin is currently standard treatment for prevention of (PEP) while ceftazidime is possible alternative treatment for patients with contraindications for nonsteroidal medicines. The aim of the study is to evaluate the efficacy of Ceftazidime for the prophylaxis of PEP.

Detailed Description
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Study type: Interventional Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: only Investigator Primary Purpose: Prevention Study Phase: Phase 4 Conditions or Focus of the study: Post ERCP pancreatitis Intervention information Intervention Names ERCP Arm Information Arm 1:Ceftazidime Arm 2 (active comparator): Diclophenac potassium

Official Title
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Diclophenac Potassium Versus Ceftazidime for Reduction of Post ERCP Pancreatitis in Average Risk Patients-double Blind, Randomised Controlled Trial

Conditions
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Pancreatitis

Intervention / Treatment
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* Drug: Ceftazidime


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: o All patients undergone to ERCP irrespectively about the diagnosis Exclusion Criteria: o Unwillingness or inability to consent for the study Age < 18 years Previous ERCP (papillotomy) Intrauterine pregnancy Breast feeding mother Allergy to Aspirin or NSAIDs and Ceftazidime NSAID or antibiotic use within 1 week (ASA 325 mg daily or less acceptable) Renal failure (Cr > 1.4) Active or recent (within 4 weeks) gastrointestinal hemorrhage Existing acute pancreatitis (lipase peak) within 72 hours prior to ERCP Anticipated inability to follow protocol

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceftazidime plus placebo<br>Procedure/Surgery: ERCP Each patient will receive: Ceftazidime 2 g i.v. once daily 30 minutes prior to procedure and glycerin suppository as placebo | Drug: Ceftazidime<br>* Patient undergone ERCP will receive either diclophenac sodium suppositories(100mg)plus placebo or ceftazidime (2g i.v.) plus placebo before procedure<br>* Other names: Fortaz;|
| Active Comparator: Diclophenac sodium plus placebo<br>Procedure/Surgery:ERCP Each patient will receive 100 mg Diclophenac suppositories, once daily immediately prior to procedure plus 100 ml of saline as placebo | Drug: Ceftazidime<br>* Patient undergone ERCP will receive either diclophenac sodium suppositories(100mg)plus placebo or ceftazidime (2g i.v.) plus placebo before procedure<br>* Other names: Fortaz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PEP in the group of patients receiving Ceftazidime versus incidence of PEP in the group of patients receiving Diclophenac potassium |  | One year | 

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