Pancreatitis Clinical Trial
Verified date | October 2007 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1600 |
Est. completion date | October 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Medical and Surgical Gastroenterology, KAS Glostrup | Copenhagen | Glostrup |
Denmark | Dept. of Medical Gastroenterology F, KAS Gentofte | Copenhagen | Hellerup |
Denmark | Gastroenheden, Hvidovre Hospital | Copenhagen | Hvidovre |
Denmark | Rigshospitalet | Copenhagen | København Ø |
Denmark | Køge County Hospital | Køge | |
Denmark | Dept of Medical Gastroenterology S, Odense Universitetshospital | Odense | |
France | North Hospital | Marseille | |
France | Serv Gastroenterologie Hopital Sainte Marguerite | Marseille | Marseille Cedex 09 |
Norway | Div of Gastroenterology, dept. of Int Medicine Affiliated Hospital University of Oslo, Østfold Fredrikstad | Fredrikstad | |
Norway | Helse Fonna HF Haugesund Sjukehus Kirurgisk - vest blokk gastro | Haugesund | |
Norway | Ullevål Hospital | Oslo | |
Norway | Stavanger Hospital | Stavanger | |
Sweden | Halmstad Hospital | Halmstad | |
Sweden | Dept of Surgery, University Hospital Malmö | Malmö |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark, France, Norway, Sweden,
Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. Review. — View Citation
Demols A, Deviere J. New frontiers in the pharmacological prevention of post-ERCP pancreatitis: the cytokines. JOP. 2003 Jan;4(1):49-57. Review. — View Citation
Freeman ML. Post-ERCP pancreatitis: patient and technique-related risk factors. JOP. 2002 Nov;3(6):169-76. Review. — View Citation
Freeman ML. Prevention of post-ERCP pancreatitis: pharmacologic solution or patient selection and pancreatic stents? Gastroenterology. 2003 Jun;124(7):1977-80. — View Citation
Harrison LI, Riedel DJ, Machacek JH, Crowley JK, Kanniainen CM, Hoglin JA, Robison TS, Zumhofe JM. Bioequivalence Comparison of Two Drug-in-Adhesive Transdermal Nitroglycerin Patches. Am J Ther. 1996 Aug;3(8):580-585. — View Citation
Mariani A. Pharmacological prevention of post-ERCP pancreatitis: which therapy is best? JOP. 2003 Jan;4(1):68-74. Review. — View Citation
Moretó M, Zaballa M, Casado I, Merino O, Rueda M, Ramírez K, Urcelay R, Baranda A. Transdermal glyceryl trinitrate for prevention of post-ERCP pancreatitis: A randomized double-blind trial. Gastrointest Endosc. 2003 Jan;57(1):1-7. — View Citation
Murray B, Carter R, Imrie C, Evans S, O'Suilleabhain C. Diclofenac reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography. Gastroenterology. 2003 Jun;124(7):1786-91. — View Citation
Pande H, Thuluvath P. Pharmacological prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis. Drugs. 2003;63(17):1799-812. Review. — View Citation
Sand J, Nordback I. Prospective randomized trial of the effect of nifedipine on pancreatic irritation after endoscopic retrograde cholangiopancreatography. Digestion. 1993;54(2):105-11. — View Citation
Sudhindran S, Bromwich E, Edwards PR. Prospective randomized double-blind placebo-controlled trial of glyceryl trinitrate in endoscopic retrograde cholangiopancreatography-induced pancreatitis. Br J Surg. 2001 Sep;88(9):1178-82. — View Citation
Testoni PA. Preventing post-ERCP pancreatitis: where are we? JOP. 2003 Jan;4(1):22-32. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | acute pancreatitis within 7 days after the ERCP procedure. (An independent committee at each center will retrospectively judge whether patients have had post-ERCP pancreatitis or not in respect to a specific definition.) | |||
Secondary | mild, moderate, and severe pancreatitis as a criterion proposed by Cotton et al [12] | |||
Secondary | post procedure pancreatitis-related mortality | |||
Secondary | adverse events (severe and non-severe such as headache, dizziness, hypotension, hypersensibility, and others) |
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