Prevention of Post-ERCP Pancreatitis by Indomethacin vs Diclofenac

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Diclofenac; Endoscopic Retrograde Cholangiopancreatography; NSAIDs; Post-ERCP Acute Pancreatitis; Indomethacin

Treatments: Drug: 100mg diclofenac; Drug: 100mg indomethacin

Study type: Interventional

Funder types: Other

Identifiers

NCT05947461

KY20232165-C-1

Details and patient eligibility

About

Post-ERCP pancreatitis (PEP) is the most common complication after ERCP, which was associated with occasional mortality, prolonged hospital days and increased health costs. Some studies investigated the effectiveness of different Nonsteroidal antiinflammatory drugs (NSAIDs) for prevent PEP. However, several high-quality RCTs and meta-analyses consistently demonstrated only100mg rectal indomethacin or diclofenac significantly reduced PEP incidence compared with placebos. Thus, European Society of Gastrointestinal Endoscopy, American Society for Gastrointestinal Endoscopy and Japanese Society of Hepato-Biliary-Pancreatic surgery guidelines recommended rountine administration of 100mg rectal indomethacin or diclofenac in unselected patients who underwent ERCP.

Up to date, the mechanisms of NSAIDs in preventing pancreatitis were not fully elucidated. Diclofenac and Indomethacin showed similar inhibitory effects in phospholipase A2 and cyclooxygenase pathways. And the peak concentration of diclofenac and indomethacin both occurs between 30 and 90 min after rectal administration. However, diclofenac may be a stronger inhibitor of other pancreatitis-related imflammatory siginals (e.g. nuclear factor kappa-B) than indomethacin. Recently, several meta-analyses found 100mg rectal diclofenac to be more efficacious than 100mg rectal indomethacin. Despite these data, there is no conclusive evidence to prove that rectal diclofenac could provide incremental benefits over indomethacin from high-quality randomized, controlled trials. Therefore, the investigators conducted a multicenter, double-blind, randomized, controlled clinical trial to evaluate the efficacy of rectal diclofenac versus indomethacin for the prevention of post-ERCP pancreatitis in average-risk patients.

Enrollment: 3,612 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-90 years old patients planned to undergo ERCP

Exclusion criteria

• Allergy to NSAIDs
• The administration of NSAIDs within 7 days
• Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction [Cr >1.4mg/dl=120umol/l]; presence of coagulopathy before the procedure)
• Previous biliary sphincterotomy and papillary large balloon dilation
• Acute pancreatitis within 3 days before ERCP
• Hemodynamical instability
• Pregnancy or lactation
• Unable to give informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,612 participants in 2 patient groups

diclofenac group

Experimental group

Description:

Patients without contraindications in diclofenac group received 100mg rectal diclofenac 30 mins before ERCP procedure.

Treatment:

Drug: 100mg diclofenac

Indomethacin group

Active Comparator group

Description:

Patients without contraindications in indomethacin group received 100mg rectal indomethacin 30 mins before ERCP procedure.

Treatment:

Drug: 100mg indomethacin