Post ERCP Pancreatitis Prevention in Average Risk Patients

University Hospital Rijeka

Status and phase: Completed; Phase 4

Conditions: Pancreatitis

Treatments: Drug: Ceftazidime

Study type: Interventional

Funder types: Other

Identifiers

NCT01784445

PEP 2013

Details and patient eligibility

About

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.

Full 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

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

124 participants in 2 patient groups

Ceftazidime plus placebo

Experimental group

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

Treatment:

Drug: Ceftazidime

Diclophenac sodium plus placebo

Active Comparator group

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

Treatment:

Drug: Ceftazidime