Timing of Indomethacin Administration for the Prevention of Post-ERCP Pancreatitis (PEP)

University of Alberta

Status and phase: Completed; Phase 4

Conditions: Acute Pancreatitis

Treatments: Drug: Rectal indomethacin 100mg one time before or after ERCP

Study type: Interventional

Funder types: Other

Identifiers

NCT02111707

Pro00041158

Details and patient eligibility

About

To determine if the timing of administration of indomethacin affects the primary outcome of post-ERCP pancreatitis (PEP). Patients undergoing ERCP will be randomly assigned to receive pre or post-procedure rectal indomethacin to prevent the occurrence of PEP.

Enrollment: 534 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients referred for ERCP at the University of Alberta
• Age greater than 18 years
• Ability to provide written informed consent

Exclusion criteria

• Acute pancreatitis
• Active peptic ulcer disease
• Rectal disease
• Aspirin-induced asthma
• Nonsteroidal anti-inflammatory drug (NSAIDs) induced hypersensitivity
• Pregnancy
• Breast feeding
• Creatinine clearance < 30 ml/min

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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534 participants in 2 patient groups

Rectal Indomethacin pre-ERCP

Active Comparator group

Description:

Patients will receive rectal indomethacin 100mg 30 minutes before procedure (ERCP).

Treatment:

Drug: Rectal indomethacin 100mg one time before or after ERCP

Rectal Indomethacin post-ERCP

Active Comparator group

Description:

Patients will receive rectal indomethacin 100mg immediately after procedure (ERCP)

Treatment:

Drug: Rectal indomethacin 100mg one time before or after ERCP