Post ERCP Pancreatitis Prevention in Average Risk Patients

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 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

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