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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00121901
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : October 18, 2007
Information provided by:
Hvidovre University Hospital

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 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.

Condition or disease Intervention/treatment Phase
Pancreatitis Drug: glyceryl nitrate Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Study Start Date : October 2004
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. mild, moderate, and severe pancreatitis as a criterion proposed by Cotton et al [12]
  2. post procedure pancreatitis-related mortality
  3. adverse events (severe and non-severe such as headache, dizziness, hypotension, hypersensibility, and others)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00121901

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Department of Medical and Surgical Gastroenterology, KAS Glostrup
Copenhagen, Glostrup, Denmark, 2600
Dept. of Medical Gastroenterology F, KAS Gentofte
Copenhagen, Hellerup, Denmark, 2900
Gastroenheden, Hvidovre Hospital
Copenhagen, Hvidovre, Denmark, 2650
Copenhagen, København Ø, Denmark, 2100
Køge County Hospital
Køge, Denmark, 4600
Dept of Medical Gastroenterology S, Odense Universitetshospital
Odense, Denmark, 5000
Serv Gastroenterologie Hopital Sainte Marguerite
Marseille, Marseille Cedex 09, France, F-13274
North Hospital
Marseille, France
Div of Gastroenterology, dept. of Int Medicine Affiliated Hospital University of Oslo, Østfold Fredrikstad
Fredrikstad, Norway, N-1603
Helse Fonna HF Haugesund Sjukehus Kirurgisk - vest blokk gastro
Haugesund, Norway, 5504
Ullevål Hospital
Oslo, Norway
Stavanger Hospital
Stavanger, Norway
Halmstad Hospital
Halmstad, Sweden
Dept of Surgery, University Hospital Malmö
Malmö, Sweden, S-205 02
Sponsors and Collaborators
Hvidovre University Hospital
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Principal Investigator: Camilla Nøjgaard Nøjgaard, MD Gastroenheden, Hvidovre Hospital, Kettegård Alle 30, 2650 Hvidovre
Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00121901    
Other Study ID Numbers: EPEPPS-06-2005
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: October 18, 2007
Last Verified: October 2007
Keywords provided by Hvidovre University Hospital:
Cholangiopancreatograpy, Endoscopic Retrograde/adverse
Randomized Controlled Trial,
Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases