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Pancreatitis | Post ERCP Pancreatitis Prevention in Average Risk Patients

Pancreatitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pancreatitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Ceftazidime plus placeboProcedure/Surgery: ERCP Each patient will receive: Ceftazidime 2 g i.v. once daily 30 minutes prior to procedure and glycerin suppository as placebo

Diclophenac sodium plus placeboProcedure/Surgery:ERCP Each patient will receive 100 mg Diclophenac suppositories, once daily immediately prior to procedure plus 100 ml of saline as placebo

Study Status

Completed

Start Date: June 2013

Completed Date: February 2015

Phase: Phase 4

Type: Interventional

Design:

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

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Goran Hauser, MD, PhD

Lead Sponsor: University Hospital Rijeka

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01784445

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