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

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00121901
First received: June 30, 2005
Last updated: October 16, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Pancreatitis
Drug: glyceryl nitrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

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

Estimated Enrollment: 1600
Study Start Date: October 2004
Study Completion Date: October 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121901

Locations
Denmark
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
Rigshospitalet
Copenhagen, København Ø, Denmark, 2100
Køge County Hospital
Køge, Denmark, 4600
Dept of Medical Gastroenterology S, Odense Universitetshospital
Odense, Denmark, 5000
France
Serv Gastroenterologie Hopital Sainte Marguerite
Marseille, Marseille Cedex 09, France, F-13274
North Hospital
Marseille, France
Norway
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
Sweden
Halmstad Hospital
Halmstad, Sweden
Dept of Surgery, University Hospital Malmö
Malmö, Sweden, S-205 02
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Camilla Nøjgaard Nøjgaard, MD Gastroenheden, Hvidovre Hospital, Kettegård Alle 30, 2650 Hvidovre
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00121901     History of Changes
Other Study ID Numbers: EPEPPS-06-2005
Study First Received: June 30, 2005
Last Updated: October 16, 2007
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Hvidovre University Hospital:
Pancreatitis
Cholangiopancreatograpy, Endoscopic Retrograde/adverse
Nitroglycerin
Randomized Controlled Trial,

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 15, 2014