Post ERCP Pancreatitis Prevention in Average Risk Patients

U

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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