Post ERCP Pancreatitis Prevention in Average Risk Patients

Phase 4

Completed

• Conditions: Pancreatitis
• Interventions: Drug: Ceftazidime

• Registration Number: NCT01784445
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-01-27
• Study First Submitted QC: 2013-02-03
• Study First Posted: 2013-02-05
• Study Start: 2013-06
• Primary Completion: 2014-09
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ceftazidime plus placebo	Ceftazidime	Procedure/Surgery: ERCP Each patient will receive: Ceftazidime 2 g i.v. once daily 30 minutes prior to procedure and glycerin suppository as placebo
Diclophenac sodium plus placebo	Ceftazidime	Procedure/Surgery:ERCP Each patient will receive 100 mg Diclophenac suppositories, once daily immediately prior to procedure plus 100 ml of saline as placebo

Primary Outcome Measures

Name	Time	Method
Incidence of PEP in the group of patients receiving Ceftazidime versus incidence of PEP in the group of patients receiving Diclophenac potassium	One year

Trial Locations

Locations (1)

Clinical Hospital Centre; 🇭🇷 Rijeka, Kresimirova 42, Croatia