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

Grigore T. Popa University of Medicine and Pharmacy

Status and phase: Unknown; Phase 4

Conditions: Post-ERCP Pancreatitis

Treatments: Drug: N-acetylcysteine (NAC); Drug: indomethacin suppository

Study type: Interventional

Funder types: Other

Identifiers

NCT03708458

PEP_2017

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 3 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Drug: indomethacin suppository

Group A

Active Comparator group

Description:

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

Treatment:

Drug: N-acetylcysteine (NAC)

Drug: indomethacin suppository

Group B

Active Comparator group

Description:

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

Treatment:

Drug: indomethacin suppository