Status:
COMPLETED
Does Glyceryl Nitrate Prevent Post-Endoscopic Retrograde Cholangiopancreaticography (ERCP) Pancreatitis?
Lead Sponsor:
Hvidovre University Hospital
Conditions:
Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 questio...
Detailed Description
Project: This study will compare glyceryl nitrate (GN) treatment to non-active treatment for the prevention of post-ERCP acute pancreatitis, which is an inflammation of the pancreas that can occur af...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT00121901
Start Date
October 1 2004
End Date
October 1 2007
Last Update
October 18 2007
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Medical and Surgical Gastroenterology, KAS Glostrup
Copenhagen, Glostrup, Denmark, 2600
2
Dept. of Medical Gastroenterology F, KAS Gentofte
Copenhagen, Hellerup, Denmark, 2900
3
Gastroenheden, Hvidovre Hospital
Copenhagen, Hvidovre, Denmark, 2650
4
Rigshospitalet
Copenhagen, København Ø, Denmark, 2100