Comparative Evaluation of Standard Prophylaxis Versus Divided-dose NSAIDs or Hybrid NSAID and N-acetylcysteine Therapy for the Prevention of Post-ERCP Pancreatitis
Overview
- Phase
- Phase 4
- Intervention
- indomethacin suppository
- Conditions
- Post-ERCP Pancreatitis
- Sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Number of patients who develop post ERCP pancreatitis
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
PAVEL LAURA
Principal Investigator, PhD Student
Grigore T. Popa University of Medicine and Pharmacy
Eligibility Criteria
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 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
Arms & Interventions
Control group
Control group - patients receiving 100 mg indomethacin suppository immediately post ERCP
Intervention: indomethacin suppository
Group A
Group A - patients receiving N-acetylcysteine (NAC) 600 mg before performing ERCP and indomethacin suppository 50 mg before and after performing ERCP
Intervention: indomethacin suppository
Group A
Group A - patients receiving N-acetylcysteine (NAC) 600 mg before performing ERCP and indomethacin suppository 50 mg before and after performing ERCP
Intervention: N-acetylcysteine (NAC)
Group B
Group B - patients receiving indomethacin suppository 50 mg before and 50 mg after ERCP
Intervention: indomethacin suppository
Outcomes
Primary Outcomes
Number of patients who develop post ERCP pancreatitis
Time Frame: 24 hours post ERCP
Comparing and evaluating the efficacy of three pharmacological combination therapies (Indomethacin +/- N-acetylcysteine), aiming to prevent acute post ERCP pancreatitis