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OpenTrials
Completed

NCT Number: NCT01784445

Post ERCP Pancreatitis Prevention in Average Risk Patients

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.

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Key information

Conditions

Pancreatitis Digestive System Diseases Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Hospital Centre

Rijeka, Kresimirova 42, 51000, Croatia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ceftazidime

Drug

Patient undergone ERCP will receive either diclophenac sodium suppositories(100mg)plus placebo or ceftazidime (2g i.v.) plus placebo before procedure

Other names: Fortaz

Primary outcomes

  1. Incidence of PEP in the group of patients receiving Ceftazidime versus incidence of PEP in the group of patients receiving Diclophenac potassium

    Time frame: One year

Other outcomes

  1. Time to discharge from hospital

    Time frame: One year

    Influence of PEP severity on time to discharge from hospital

Sponsors and collaborators

Lead sponsor

University Hospital Rijeka

Other

Registry information

Official study title

Diclophenac Potassium Versus Ceftazidime for Reduction of Post ERCP Pancreatitis in Average Risk Patients-double Blind, Randomised Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Feb 5, 2013
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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