Post ERCP Pancreatitis Prevention in Average Risk Patients

University Hospital Rijeka124 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

124

Conditions

Pancreatitis

Interventions

CeftazidimeDRUG

Patient undergone ERCP will receive either diclophenac sodium suppositories(100mg)plus placebo or ceftazidime (2g i.v.) plus placebo before procedure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinical Hospital Centre

Rijeka, Kresimirova 42, Croatia

Outcomes

Primary Outcomes

Incidence of PEP in the group of patients receiving Ceftazidime versus incidence of PEP in the group of patients receiving Diclophenac potassium

Time frame: One year

Data from ClinicalTrials.gov

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