Does Glyceryl Nitrate Prevent Post-Endoscopic Retrograde Cholangiopancreaticography (ERCP) Pancreatitis?
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|ClinicalTrials.gov Identifier: NCT00121901|
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : October 18, 2007
|First Submitted Date ICMJE||June 30, 2005|
|First Posted Date ICMJE||July 21, 2005|
|Last Update Posted Date||October 18, 2007|
|Study Start Date ICMJE||October 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.)|
|Original Primary Outcome Measures ICMJE
||Acute pancreatitis within 7 days after the ERCP procedure. An independent committee at each center will judge retrospectively whether a patients have had post-ERCP or not in respect to a specific definition|
|Change History||Complete list of historical versions of study NCT00121901 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Does Glyceryl Nitrate Prevent Post-Endoscopic Retrograde Cholangiopancreaticography (ERCP) Pancreatitis?|
|Official Title ICMJE||Not Provided|
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.
This study will compare glyceryl nitrate (GN) treatment to non-active treatment for the prevention of post-ERCP acute pancreatitis, which is an inflammation of the pancreas that can occur after a procedure known as ERCP.
ERCP (endoscopic retrograde cholangiopancreaticography) is an examination of the pancreas by which it is possible to perform therapeutic measures such as stone removal from the common bile duct and visualisation of the pancreas. Inflammation of the pancreas after the ERCP procedure (called: post-ERCP pancreatitis) is the most feared and common complication of the ERCP. It occurs in 1-40% of patients, with rates of 5% or more being more typical. Currently, the background of post-ERCP pancreatitis is poorly known.
Attempts at preventing post-ERCP pancreatitis have been carried out through a change to low-risk techniques, by avoiding high-risk patients, and by use of pharmacological prophylaxis.
Glyceryl nitrate is a well-known medicine used for many years in other diseases. Possible side effects are headache and low blood pressure. Other side effects such as dizziness, tiredness, nausea, local redness at the application site and allergic reactions of the skin are rare.
The purpose of this study is to document that pre-treatment with GN is effective in preventing post-ERCP pancreatitis. In two earlier GN studies, sample sizes were relatively small (less than one hundred) and the rates of post-ERCP pancreatitis in the control group were quite high (15-17%). Therefore, further studies are needed to confirm the promising effect of GN in the prophylaxis of post-ERCP pancreatitis.
The study includes every patient undergoing ERCP above the age of 18 years. Patients are excluded if they have active acute pancreatitis, previous sphincterotomy (cut in the sphincter at the end of the biliary and pancreatic ducts in the duodenum) or chronic pancreatitis with calcifications. Also, patients may not take sildenafil (Viagra) as GN should not be taken together with sildenafil. Patients allergic to glyceryl nitrate or glue should not be included. Patients with constrictive pericarditis (inflammation and fibrosis in the sack around the heart); pericardial tamponade (blood or liquor in the sack around the heart); low blood pressure; aortic stenosis (stenosis of the aortic valve); hypertrophic obstructive cardiomyopathy (a special disease with thickness of the heart); mitral stenosis (stenosis of the mitral valve); anemia (low hemoglobin); and untreated hypothyroidism (thyroid disease) are excluded because these are other diseases to which glyceryl nitrate should not be used. Pregnant women are excluded. Patients can only be included once.
Patients have been preparing for the study as if it was a normal procedure. Prior to the procedure, patients will be asked to participate in the study. If the patients accept, after oral and written consent, they will receive either a GN patch or non-active patch on the chestwall 40-60 minutes prior to the ERCP procedure.
A canula is inserted in a cubital vein for medication. The ERCP is initiated, and patients are observed afterwards according to local practice, which is typically 3 hours. Patients are asked to fill out a letter with questions related to symptoms of pancreatitis (pain, fever, nausea, vomiting, hospitalization) to send to the investigating center after 7 days. If patients do not send the letter they will be contacted by phone within 14 days.
An interim analysis will be made, when 800 patients have been included. The study will stop, if 1) the interim analysis shows a significant higher mortality in one group than in the other or 2) if the study has proceeded more than 2 years.
The project is a multicenter trial of the European Post-ERCP Pancreatitis Preventing Study Group. This local project is located at XX-department. No commercial interests are involved. The investigators/authors work for free against authorship. Finances are sought through funds for research.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Intervention ICMJE||Drug: glyceryl nitrate|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE||Same as current|
|Actual Study Completion Date||October 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Denmark, France, Norway, Sweden|
|Removed Location Countries||Finland, Germany|
|NCT Number ICMJE||NCT00121901|
|Other Study ID Numbers ICMJE||EPEPPS-06-2005|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Hvidovre University Hospital|
|Collaborators ICMJE||Not Provided|
|PRS Account||Hvidovre University Hospital|
|Verification Date||October 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP