Post ERCP Pancreatitis Prevention in Average Risk Patients

NCT ID: NCT01784445

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-02-28

Brief Summary

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

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

Conditions

Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Ceftazidime plus placebo

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

Group Type: EXPERIMENTAL

Ceftazidime

Intervention Type: DRUG

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

Diclophenac sodium plus placebo

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

Group Type: ACTIVE_COMPARATOR

Ceftazidime

Intervention Type: DRUG

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

Interventions

Ceftazidime

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

Intervention Type: DRUG

Other Intervention Names

Fortaz

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Rijeka

OTHER

Sponsor Role: lead

Responsible Party

Goran Hauser

Goran Hauser, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Goran Hauser, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Rijeka

Locations

Clinical Hospital Centre

Rijeka, Kresimirova 42, Croatia

Countries

Croatia

Other Identifiers

PEP 2013

Identifier Type: -

Identifier Source: org_study_id