Does Glyceryl Nitrate Prevent Post-Endoscopic Retrograde Cholangiopancreaticography (ERCP) Pancreatitis?
Status:
Completed
Trial end date:
2007-10-01
Target enrollment:
Participant gender:
Summary
Post-ERCP pancreatitis can be a serious complication to ERCP. Two studies have shown a
promising preventive effect of glyceryl nitrate. This study should provide a final answer to
the clinical question: Does glyceryl nitrate prevent post-ERCP pancreatitis? The study is a
prospective, randomized, double blind, placebo-controlled multicenter trial. The
investigators intend to include 1600 patients from Norway, Sweden, Denmark, and France.
The patients will receive either placebo or a glyceryl nitrate patch (15 mg/24 hours).
Follow-up will occur after 7 days. The primary outcome measure will be post-ERCP
pancreatitis, and secondary outcome measures will be mild, moderate and severe pancreatitis;
post procedure pancreatitis-related mortality; and adverse events.