Does Glyceryl Nitrate Prevent Post-Endoscopic Retrograde Cholangiopancreaticography (ERCP) Pancreatitis?

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hvidovre University Hospital

Criteria

Inclusion Criteria:

• All patients (men and women) more than 18 years old who are going to have an ERCP procedure performed at the different centers from September 1, 2004 to about January 31, 2005 will be included.

Exclusion Criteria:

• Before the study: active acute pancreatitis (defined as: acute upper abdominal pain and S-amylases x 3 upper normal limit OR upper abdominal pain + radiological findings [CAT-/MR-scan] consistent with acute pancreatitis OR pathoanatomical findings consistent with acute pancreatitis by surgery)

• Known previous sphincterotomy

• Chronic pancreatitis with known calcifications

• Hypotension (definition: systolic blood pressure < 100 mmHg)

• Anemia, men/women (hemoglobin < 6 mmol/l or <9.7 g/dl)

• Constrictive pericarditis

• Pericardial tamponade

• Hypertrophic obstructive cardiomyopathy, aortic stenosis

• Mitral stenosis sildenafil within 24 hours before the ERCP procedure and 24 hours after the procedure

• Hypersensibility to nitroglycerine

• Hypersensibility to the applied glue on the patch

• Known untreated hypothyroidism

• Pregnancy or a potential to become pregnant, i.e. those who are not using safe contraception (intrauterine device [IUD] or oral contraception)

• Included earlier in the study

• Exchange of stent