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

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Evaluation of Standard Prophylaxis Versus Divided-dose NSAIDs or Hybrid NSAID and N-acetylcysteine Therapy for the Prevention of Post-ERCP Pancreatitis

Conditions
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Post-ERCP Pancreatitis

Intervention / Treatment
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* Drug: indomethacin suppository
* Drug: N-acetylcysteine (NAC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Control group - patients receiving 100 mg indomethacin suppository immediately post ERCP | Drug: indomethacin suppository<br>* 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<br>|
| Active Comparator: Group A<br>Group A - patients receiving N-acetylcysteine (NAC) 600 mg before performing ERCP and indomethacin suppository 50 mg before and after performing ERCP | Drug: indomethacin suppository<br>* 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<br>Drug: N-acetylcysteine (NAC)<br>* 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<br>|
| Active Comparator: Group B<br>Group B - patients receiving indomethacin suppository 50 mg before and 50 mg after ERCP | Drug: indomethacin suppository<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who develop post ERCP pancreatitis | Comparing and evaluating the efficacy of three pharmacological combination therapies (Indomethacin +/- N-acetylcysteine), aiming to prevent acute post ERCP pancreatitis | 24 hours post ERCP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic retrograde cholangiopancreatography (ERCP), post-ERCP pancreatitis (PEP), Nonsteroidal anti-inflammatory drugs (NSAID's), acetylcysteine (ACC)