Post ERCP Pancreatitis Prevention in Average Risk Patients

April 6, 2015 updated by: Goran Hauser, University Hospital Rijeka

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
    • Kresimirova 42
      • Rijeka, Kresimirova 42, Croatia, 51000
        • Clinical Hospital Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Ceftazidime
Patient undergone ERCP will receive either diclophenac sodium suppositories(100mg)plus placebo or ceftazidime (2g i.v.) plus placebo before procedure
Other Names:
  • Fortaz
Active Comparator: 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
Drug: Ceftazidime
Patient undergone ERCP will receive either diclophenac sodium suppositories(100mg)plus placebo or ceftazidime (2g i.v.) plus placebo before procedure
Other Names:
  • Fortaz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to discharge from hospital
Time Frame: One year
Influence of PEP severity on time to discharge from hospital
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Rijeka

Investigators

  • Principal Investigator: Goran Hauser, MD, PhD, University Hospital Rijeka

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

January 27, 2013

First Submitted That Met QC Criteria

February 3, 2013

First Posted (Estimate)

February 5, 2013

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatitis

Clinical Trials on Ceftazidime

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe