Trial | NCT03708458  Report issue

Title

Pharmacological Prophylaxis of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
Comparative Evaluation of Standard Prophylaxis Versus Divided-dose NSAIDs or Hybrid NSAID and N-acetylcysteine Therapy for the Prevention of Post-ERCP Pancreatitis

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    250
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.
Study Started
Apr 01
2017
Primary Completion
Dec 15
2018
Anticipated
Study Completion
Dec 15
2018
Anticipated
Last Update
Oct 18
2018

Drug indomethacin suppository

the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens

Drug N-acetylcysteine (NAC)

the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens

Control group Active Comparator

Control group - patients receiving 100 mg indomethacin suppository immediately post ERCP

Group A Active Comparator

Group A - patients receiving N-acetylcysteine (NAC) 600 mg before performing ERCP and indomethacin suppository 50 mg before and after performing ERCP

Group B Active Comparator

Group B - patients receiving indomethacin suppository 50 mg before and 50 mg after ERCP

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
No Results Posted