NCT04425993

Rectal Indomethacin Versus Rectal Indomethacin and Sublingual Nitrate for PEP Prevention

Rectal Indomethacin Versus Rectal Indomethacin and Sublingual Nitrate to Prevent Post-ERCP Pancreatitis: a Multicentre, Non-inferiority, Double-blind, Randomised Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,700 (actual)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) are at risk for post-ERCP pancreatitis (PEP), which is associated with adverse outcomes. Combination prophylaxis strategies are increasingly investigated to prevent PEP more effectively, and studies have confirmed the benefits. Two randomized controlled trials revealed that combination prophylaxis with rectal NSAIDs and sublingual nitrate has reduced PEP rates to 5.6%-6.7% in average-risk patients. However, there was concern regarding the safety of sublingual nitrate with reports of significant increasing the risk of hypotesion (rate of 54.9%) and headache (rate of 4.1%) as compared with placebo. As a safety drug, rectal administration of one dose NSAIDs is recommended as basic chemoprophylaxis in common or high-risk patients in guidelines. Results from previous studies showed rectal administration of NSAIDs significantly reduced PEP rate to 4-5.3% in average-risk patients. Although the difference in demographics, study design and outcomes definition, evidence was obtained that rectal NSAIDS was associated with similar PEP rate as combination prophylaxis with rectal NSAIDs and sublingual nitrate. However, evidence is lacking from large, randomized clinical trials indicating that efficiency of PEP prevention with rectal NSAIDs alone is not inferior to with combination prophylaxis. The investigators conduct this trial to investigate the hypothesis that rectal NSAIDs alone is non-inferior to the combination prophylaxis in terms of PEP prevention, but with reduce side effect.

Conditions

• Post-ERCP Acute Pancreatitis

Interventions

Type	Name	Description
DRUG	Isosorbide Dinitrate 5 MG	All patients without contraindications should receive sublingual isosorbide dinitrate tablet within 5 minutes before ERCP.
DRUG	Indomethacin 100 MG	All patients without contraindications should receive rectal indomethacin within 30 min before ERCP.
DRUG	Sublingual Placebo	All patients without contraindications should receive sublingual placebo within 5 minutes before ERCP.
DRUG	Rectal placebo	All patients without contraindications should receive rectal placebo within 30 min before ERCP.

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-05-30
• Completion: 2022-12-30
• First posted: 2020-06-11
• Last updated: 2020-10-22

Locations

4 sites across 1 country: China