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

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:

Genetics Home Reference related topics: hereditary pancreatitis

MedlinePlus related topics: Endoscopy Pancreatitis

U.S. FDA Resources

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

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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:

Freeman ML. Post-ERCP pancreatitis: patient and technique-related risk factors. JOP. 2002 Nov;3(6):169-76. Review. No abstract available.

Demols A, Deviere J. New frontiers in the pharmacological prevention of post-ERCP pancreatitis: the cytokines. JOP. 2003 Jan;4(1):49-57. Review.

Testoni PA. Preventing post-ERCP pancreatitis: where are we? JOP. 2003 Jan;4(1):22-32. Review.

Mariani A. Pharmacological prevention of post-ERCP pancreatitis: which therapy is best? JOP. 2003 Jan;4(1):68-74. Review.

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.

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.

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.

Moreto M, Zaballa M, Casado I, Merino O, Rueda M, Ramirez 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.

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.

Pande H, Thuluvath P. Pharmacological prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis. Drugs. 2003;63(17):1799-812. Review.

Freeman ML. Prevention of post-ERCP pancreatitis: pharmacologic solution or patient selection and pancreatic stents? Gastroenterology. 2003 Jun;124(7):1977-80. No abstract available.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nøjgaard C, Hornum M, Elkjaer M, Hjalmarsson C, Heyries L, Hauge T, Bakkevold K, Andersen PK, Matzen P; European Post-ERCP Pancreatitis Preventing Study Group. Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial. Gastrointest Endosc. 2009 May;69(6):e31-7.

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 May 16, 2013