NCT05947461

Prevention of Post-ERCP Pancreatitis by Indomethacin vs Diclofenac

Rectal Disclofenac Versus Indomethacin for Prevention of Post-ERCP Pancreatitis (DIPPP): A Multicentre, Double-blind, Randomised, Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,204 (actual)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Post-ERCP Acute Pancreatitis
• NSAIDs
• Indomethacin
• Diclofenac
• Endoscopic Retrograde Cholangiopancreatography

Interventions

Type	Name	Description
DRUG	100mg diclofenac	All patients without contraindications should receive 100mg rectal diclofenac 30mins before ERCP procedure
DRUG	100mg indomethacin	All patients without contraindications should receive 100mg rectal indomethacin 30mins before ERCP procedure

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-06-22
• Completion: 2024-06-22
• First posted: 2023-07-17
• Last updated: 2024-10-28

Locations

11 sites across 1 country: China