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

Phase 4

• Conditions: Post-ERCP Pancreatitis
• Interventions: Drug: indomethacin suppository; Drug: N-acetylcysteine (NAC)

• Registration Number: NCT03708458
• Lead Sponsor: Grigore T. Popa University of Medicine and Pharmacy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Status Verified: 2018-10
• Study First Submitted: 2018-10-14
• Study First Submitted QC: 2018-10-14
• Last Update Submitted: 2018-10-16
• Study First Posted: 2018-10-17
• Last Update Posted: 2018-10-18
• Primary Completion: 2018-12-15
• Study Completion: 2018-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	indomethacin suppository	Group B - patients receiving indomethacin suppository 50 mg before and 50 mg after ERCP
Control group	indomethacin suppository	Control group - patients receiving 100 mg indomethacin suppository immediately post ERCP
Group A	indomethacin suppository	Group A - patients receiving N-acetylcysteine (NAC) 600 mg before performing ERCP and indomethacin suppository 50 mg before and after performing ERCP
Group A	N-acetylcysteine (NAC)	Group A - patients receiving N-acetylcysteine (NAC) 600 mg before performing ERCP and indomethacin suppository 50 mg before and after performing ERCP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Gastroenterology and Hepatology - St. Spiridon County Clinical Emergency Hospital of Iași; 🇷🇴 Iași, Romania