Pharmacological Prophylaxis of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Last updated: October 16, 2018
Sponsor: Grigore T. Popa University of Medicine and Pharmacy
Overall Status: Active - Recruiting

Phase

4

Condition

Pancreatitis

Treatment

N/A

Clinical Study ID

NCT03708458
PEP_2017
  • Ages > 18
  • All Genders

Study Summary

The investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of post-ERCP pancreatitis, using pharmacologic agents with different mechanisms of action (NSAIDs and/or acetylcysteine) in three different regimens.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age 18 years and older

  • diagnosis of choledocholithiasis

  • indication for ERCP procedures

  • willingness to participate in the study

  • the ability to sign the informed consent

Exclusion

Exclusion Criteria:

  • presence of acute pancreatitis or other inflammatory diseases at admission

  • pregnancy

  • contraindication for NSAID administration

  • recent episode of upper digestive bleeding (less than one month)

  • hypersensibility to antioxidants hypersensibility to antioxidants

  • the necessity of a prophylactic pancreatic stent insertion

  • patients' disapproval to take part in the study

Study Design

Total Participants: 250
Study Start date:
April 01, 2017
Estimated Completion Date:
December 15, 2018

Connect with a study center

  • Institute of Gastroenterology and Hepatology - St. Spiridon County Clinical Emergency Hospital of Iași

    Iași, cod 700111
    Romania

    Active - Recruiting

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