Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121901
Status:
COMPLETED
Last Update Posted:
2007-10-18
First Post:
2005-06-30
Brief Title:
Does Glyceryl Nitrate Prevent Post-Endoscopic Retrograde Cholangiopancreaticography ERCP Pancreatitis
Sponsor:
Hvidovre University Hospital
Organization:
Hvidovre University Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mg24 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
The patients will receive either placebo or a glyceryl nitrate patch 15 mg24 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
Detailed Description:
Project
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
Background
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
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
Aim
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
Participants
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
Practical
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
Interim analysis
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
Economy
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 investigatorsauthors work for free against authorship Finances are sought through funds for research
References
1 Freeman M Post-ERCP pancreatitis patient and technique-related risk factors JOP 200236169-176
2 Demols A Deviere J New frontiers in the pharmacological prevention of post-ERCP pancreatitis the cytokines JOP 2003 4149-57
3 Testoni P Preventing post-ERCP pancreatitis where are we JOP 2003 4122-32
4 Mariani A Pharmacological prevention of post-ERCP pancreatitiswhich therapy is best JOP 2003 4168-74
5 Murray B Carter R et al Diclofenac reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography Gastroenterology 2003 1241786-1791
6 Sand J Nordback I Prospective randomized trial of the effect of nifedipine on pancreatic irritation after endoscopic retrograde cholangiopancreatography Digestion 1993 54105-11
7 Sudhindran S Bromwich E et al Prospective randomized double-blind placebo-controlled trial of glyceryl trinitrate in endoscopic retrograde cholangiopancreaticography-induced pancreatitis British J of Surg 2001 881178-1182
8 Moreto M Zaballa M et al Transdermal glyceryl trinitrate for prevention of post-ERCP pancreatitis a randomized double-blind trial Gastrointest Endoscopy 2003571-7
9 Harrison et al Bioequivalence comparison of two drug-in-adhesive transdermal nitroglycerine patches Am J Ther 19963580-585
10 Pande H Thuluvath PJ Pharmacological prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis Drugs 200363171799-1812
11 Freeman ML Prevention of post-ERCP pancreatitis Pharmacologic solution or patient selection and pancreatic stents Gastroenterology 200312471977-1980
12 Cotton PB Lehman G Vennes J Geenen JE et al Endoscopic sphincterotomy complications and their management an attempt at consensus Gastrointest Endosc 199137383-393
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
Background
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
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
Aim
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
Participants
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
Practical
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
Interim analysis
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
Economy
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 investigatorsauthors work for free against authorship Finances are sought through funds for research
References
1 Freeman M Post-ERCP pancreatitis patient and technique-related risk factors JOP 200236169-176
2 Demols A Deviere J New frontiers in the pharmacological prevention of post-ERCP pancreatitis the cytokines JOP 2003 4149-57
3 Testoni P Preventing post-ERCP pancreatitis where are we JOP 2003 4122-32
4 Mariani A Pharmacological prevention of post-ERCP pancreatitiswhich therapy is best JOP 2003 4168-74
5 Murray B Carter R et al Diclofenac reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography Gastroenterology 2003 1241786-1791
6 Sand J Nordback I Prospective randomized trial of the effect of nifedipine on pancreatic irritation after endoscopic retrograde cholangiopancreatography Digestion 1993 54105-11
7 Sudhindran S Bromwich E et al Prospective randomized double-blind placebo-controlled trial of glyceryl trinitrate in endoscopic retrograde cholangiopancreaticography-induced pancreatitis British J of Surg 2001 881178-1182
8 Moreto M Zaballa M et al Transdermal glyceryl trinitrate for prevention of post-ERCP pancreatitis a randomized double-blind trial Gastrointest Endoscopy 2003571-7
9 Harrison et al Bioequivalence comparison of two drug-in-adhesive transdermal nitroglycerine patches Am J Ther 19963580-585
10 Pande H Thuluvath PJ Pharmacological prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis Drugs 200363171799-1812
11 Freeman ML Prevention of post-ERCP pancreatitis Pharmacologic solution or patient selection and pancreatic stents Gastroenterology 200312471977-1980
12 Cotton PB Lehman G Vennes J Geenen JE et al Endoscopic sphincterotomy complications and their management an attempt at consensus Gastrointest Endosc 199137383-393
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None