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Post ERCP Pancreatitis Prevention in Average Risk Patients

Primary Purpose

Pancreatitis

Status
Completed
Phase
Phase 4
Locations
Croatia
Study Type
Interventional
Intervention
Ceftazidime
Sponsored by
University Hospital Rijeka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatitis focused on measuring Endoscopic Retrograde Cholangiopancreatography,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Hospital Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ceftazidime plus placebo

Diclophenac sodium plus placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 27, 2013
Last Updated
April 6, 2015
Sponsor
University Hospital Rijeka
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1. Study Identification

Unique Protocol Identification Number
NCT01784445
Brief Title
Post ERCP Pancreatitis Prevention in Average Risk Patients
Official Title
Diclophenac Potassium Versus Ceftazidime for Reduction of Post ERCP Pancreatitis in Average Risk Patients-double Blind, Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Rijeka

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
Endoscopic Retrograde Cholangiopancreatography,

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceftazidime plus placebo
Arm Type
Experimental
Arm Description
Procedure/Surgery: ERCP Each patient will receive: Ceftazidime 2 g i.v. once daily 30 minutes prior to procedure and glycerin suppository as placebo
Arm Title
Diclophenac sodium plus placebo
Arm Type
Active Comparator
Arm Description
Procedure/Surgery:ERCP Each patient will receive 100 mg Diclophenac suppositories, once daily immediately prior to procedure plus 100 ml of saline as placebo
Intervention Type
Drug
Intervention Name(s)
Ceftazidime
Other Intervention Name(s)
Fortaz
Intervention Description
Patient undergone ERCP will receive either diclophenac sodium suppositories(100mg)plus placebo or ceftazidime (2g i.v.) plus placebo before procedure
Primary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
Time to discharge from hospital
Description
Influence of PEP severity on time to discharge from hospital
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Goran Hauser, MD, PhD
Organizational Affiliation
University Hospital Rijeka
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Hospital Centre
City
Rijeka
State/Province
Kresimirova 42
ZIP/Postal Code
51000
Country
Croatia

12. IPD Sharing Statement

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Post ERCP Pancreatitis Prevention in Average Risk Patients

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