Rectal Indomethacin Versus Rectal Indomethacin and Sublingual Nitrate for PEP Prevention
Status:
Active, not recruiting
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Air Force Military Medical University, China Fourth Military Medical University