Post ERCP Pancreatitis Prevention in Average Risk Patients
Information source: University Hospital Rijeka
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatitis
Intervention: Ceftazidime (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University Hospital Rijeka Official(s) and/or principal investigator(s): Goran Hauser, MD, PhD, Principal Investigator, Affiliation: University Hospital Rijeka
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.
Clinical Details
Official title: Diclophenac Potassium Versus Ceftazidime for Reduction of Post ERCP Pancreatitis in Average Risk Patients-double Blind, Randomised Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Incidence of PEP in the group of patients receiving Ceftazidime versus incidence of PEP in the group of patients receiving Diclophenac potassium
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Clinical Hospital Centre, Rijeka, Kresimirova 42 51000, Croatia
Additional Information
Starting date: June 2013
Last updated: April 6, 2015
|