NCT00121901

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2004

Typical duration for phase_3

Geographic Reach
4 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 18, 2007

Status Verified

October 1, 2007

First QC Date

June 30, 2005

Last Update Submit

October 16, 2007

Conditions

Pancreatitis

Keywords

PancreatitisCholangiopancreatograpy, Endoscopic Retrograde/adverseNitroglycerinRandomized Controlled Trial,

Outcome Measures

Primary Outcomes (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 Outcomes (3)

  • 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)

Interventions

glyceryl nitrateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Department of Medical and Surgical Gastroenterology, KAS Glostrup

Copenhagen, Glostrup, 2600, Denmark

Location

Dept. of Medical Gastroenterology F, KAS Gentofte

Copenhagen, Hellerup, 2900, Denmark

Location

Gastroenheden, Hvidovre Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

Rigshospitalet

Copenhagen, København Ø, 2100, Denmark

Location

Køge County Hospital

Køge, Køge, 4600, Denmark

Location

Dept of Medical Gastroenterology S, Odense Universitetshospital

Odense, Odense, 5000, Denmark

Location

Serv Gastroenterologie Hopital Sainte Marguerite

Marseille, Marseille Cedex 09, F-13274, France

Location

North Hospital

Marseille, Marseille, France

Location

Div of Gastroenterology, dept. of Int Medicine Affiliated Hospital University of Oslo, Østfold Fredrikstad

Fredrikstad, Fredrikstad, N-1603, Norway

Location

Helse Fonna HF Haugesund Sjukehus Kirurgisk - vest blokk gastro

Haugesund, Haugesund, 5504, Norway

Location

Ullevål Hospital

Oslo, Oslo County, Norway

Location

Stavanger Hospital

Stavanger, Stavanger, Norway

Location

Halmstad Hospital

Halmstad, Halmstad, Sweden

Location

Dept of Surgery, University Hospital Malmö

Malmo, Malmö, S-205 02, Sweden

Location

Related Publications (13)

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

    PMID: 12432183RESULT

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

    PMID: 12555016RESULT

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

    PMID: 12555013RESULT

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

    PMID: 12555018RESULT

  • 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. doi: 10.1016/s0016-5085(03)00384-6.

    PMID: 12806612RESULT

  • 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. doi: 10.1159/000201021.

    PMID: 8319838RESULT

  • 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. doi: 10.1046/j.0007-1323.2001.01842.x.

    PMID: 11531863RESULT

  • 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. doi: 10.1067/mge.2003.29.

    PMID: 12518122RESULT

  • 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. doi: 10.1097/00045391-199608000-00006.

    PMID: 11862294RESULT

  • Pande H, Thuluvath P. Pharmacological prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis. Drugs. 2003;63(17):1799-812. doi: 10.2165/00003495-200363170-00003.

    PMID: 12921486RESULT

  • Freeman ML. Prevention of post-ERCP pancreatitis: pharmacologic solution or patient selection and pancreatic stents? Gastroenterology. 2003 Jun;124(7):1977-80. doi: 10.1016/s0016-5085(03)00553-5. No abstract available.

    PMID: 12806633RESULT

  • 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. doi: 10.1016/s0016-5107(91)70740-2.

    PMID: 2070995RESULT

  • Nojgaard 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. doi: 10.1016/j.gie.2008.11.042.

    PMID: 19410035DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Camilla Nøjgaard Nøjgaard, MD

    Gastroenheden, Hvidovre Hospital, Kettegård Alle 30, 2650 Hvidovre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 21, 2005

Study Start

October 1, 2004

Study Completion

October 1, 2007

Last Updated

October 18, 2007

Record last verified: 2007-10

Locations

NO(4)FR(2)DK(6)SE(2)