Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post ERCP Pancreatitis Prevention in Average Risk Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01784445
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
Goran Hauser, University Hospital Rijeka

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.

Condition or disease Intervention/treatment Phase
Pancreatitis Drug: Ceftazidime Phase 4

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Diclophenac Potassium Versus Ceftazidime for Reduction of Post ERCP Pancreatitis in Average Risk Patients-double Blind, Randomised Controlled Trial
Study Start Date : June 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : February 2015


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 Name: 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 Name: Fortaz




Primary Outcome Measures :
  1. 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 Outcome Measures:
  1. Time to discharge from hospital [ Time Frame: One year ]
    Influence of PEP severity on time to discharge from hospital



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784445


Locations
Layout table for location information
Croatia
Clinical Hospital Centre
Rijeka, Kresimirova 42, Croatia, 51000
Sponsors and Collaborators
University Hospital Rijeka
Investigators
Layout table for investigator information
Principal Investigator: Goran Hauser, MD, PhD University Hospital Rijeka

Layout table for additonal information
Responsible Party: Goran Hauser, Goran Hauser, MD, PhD, University Hospital Rijeka
ClinicalTrials.gov Identifier: NCT01784445     History of Changes
Other Study ID Numbers: PEP 2013
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015
Keywords provided by Goran Hauser, University Hospital Rijeka:
Endoscopic Retrograde Cholangiopancreatography,
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Ceftazidime
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents