Ignite Creation Date:
2024-05-06 @ 12:11 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01514214
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2012-01-16
Brief Title:
Winged Perimeter Versus Traditional Plastic Biliary Stent for Malignant Bile Duct Obstruction
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
A Randomized Trial Comparing a Winged Perimeter Stent and Traditional Polyethylene Plastic Stent in the Management of Malignant Distal Biliary Strictures
Status:
COMPLETED
Status Verified Date:
2018-04
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:
Strictures in the bile duct cause a blockage of flow of bile This leads to potential problems including jaundice itch and infection in the bile duct The usual first step in this situation would be to allow flow of bile by placing a stent across the stricture This is usually done by a special type of endoscopy procedure called an endoscopic retrograde cholangiopancreatography or ERCP
The most commonly used stent are made from a plastic material called polyethylene and has a central lumen in which bile drains through it Health Canada has approved the sale and use of another stent with a winged perimeter the VIADUCT stent for placement in bile duct strictures and is used routinely in our hospitals However the investigators do not know which stent is better at treating bile duct strictures In order to determine which stent would be more useful the VIADUCT stent and the usual polyethylene flanged stent must be studied under carefully controlled circumstances This will be done by a randomized subject-blinded study Other trials in the past have looked at other stents in this way but this is the first time the VIADUCT stent has been looked at in this manner The investigators suspect that the design of the VIADUCT stent will allow it to work for a longer period of time compared to the traditional polyethylene stent
The most commonly used stent are made from a plastic material called polyethylene and has a central lumen in which bile drains through it Health Canada has approved the sale and use of another stent with a winged perimeter the VIADUCT stent for placement in bile duct strictures and is used routinely in our hospitals However the investigators do not know which stent is better at treating bile duct strictures In order to determine which stent would be more useful the VIADUCT stent and the usual polyethylene flanged stent must be studied under carefully controlled circumstances This will be done by a randomized subject-blinded study Other trials in the past have looked at other stents in this way but this is the first time the VIADUCT stent has been looked at in this manner The investigators suspect that the design of the VIADUCT stent will allow it to work for a longer period of time compared to the traditional polyethylene stent
Detailed Description:
Biliary obstruction usually presents with jaundice pruritis cholangitis and steatorrhoea Strictures which are a common cause of biliary obstruction may be secondary to benign or malignant conditions Common benign conditions include chronic pancreatitis primary sclerosing cholangitis autoimmune pancreatitis prior surgery and recurrent pyogenic cholangitis Cholangiocarcinomas ampullary and pancreatic tumours are more common causes of malignant biliary obstruction
The principles of managing biliary strictures are to determine the underlying cause of the stricture whilst achieving drainage of the biliary tree initially with the placement of a plastic stent via an endoscopic retrograde cholangiopancreatography ERCP Strictures are sampled using biliary brush cytology andor biliary biopsy to assess for underlying malignancy Malignant strictures are usually staged for resectability with computed tomography CT magnetic resonance cholangiopancreatography MRCP andor endoscopic ultrasound EUS
The Viaduct stent GI Supply Camp Hill Pennsylvania USA is a unique stent design and has a winged perimeter which channels flow of bile around the stent rather than through a central lumen Theoretically this may enhance flow and biliary drainage and prevent obstruction Both polyethylene and Viaduct plastic stents are approved for use by Health Canada for benign and malignant biliary conditions It is not known whether one stent is superior to the other in maintaining symptomatic relief from bile duct strictures as there have been no studies to date comparing the two stents
There is limited published data on the Viaduct stent A pilot study of the winged stent design was published in 2006 Five patients had winged stents inserted and followed for 2 weeks The were no problems with stent insertion and symptoms of obstruction and jaundice improved over this time One study published in abstract form retrospectively compared 34 Viaduct stents matched with 240 conventional stents over a five year period There was no statistical difference with stent dysfunction and a trend towards patency with the Viaduct stent
The primary aim of this study is to compare the stent patency time in the Viaduct and polyethylene stent groups in subjects with malignant bile duct strictures The secondary aims are to determine the etiology of stent failure in the two treatment groups to identify and compare device-related adverse events in the two treatment groups to identify other patient factors associated with stent failure and to compare survival between the Viaduct and polyethylene stent groups
The principles of managing biliary strictures are to determine the underlying cause of the stricture whilst achieving drainage of the biliary tree initially with the placement of a plastic stent via an endoscopic retrograde cholangiopancreatography ERCP Strictures are sampled using biliary brush cytology andor biliary biopsy to assess for underlying malignancy Malignant strictures are usually staged for resectability with computed tomography CT magnetic resonance cholangiopancreatography MRCP andor endoscopic ultrasound EUS
The Viaduct stent GI Supply Camp Hill Pennsylvania USA is a unique stent design and has a winged perimeter which channels flow of bile around the stent rather than through a central lumen Theoretically this may enhance flow and biliary drainage and prevent obstruction Both polyethylene and Viaduct plastic stents are approved for use by Health Canada for benign and malignant biliary conditions It is not known whether one stent is superior to the other in maintaining symptomatic relief from bile duct strictures as there have been no studies to date comparing the two stents
There is limited published data on the Viaduct stent A pilot study of the winged stent design was published in 2006 Five patients had winged stents inserted and followed for 2 weeks The were no problems with stent insertion and symptoms of obstruction and jaundice improved over this time One study published in abstract form retrospectively compared 34 Viaduct stents matched with 240 conventional stents over a five year period There was no statistical difference with stent dysfunction and a trend towards patency with the Viaduct stent
The primary aim of this study is to compare the stent patency time in the Viaduct and polyethylene stent groups in subjects with malignant bile duct strictures The secondary aims are to determine the etiology of stent failure in the two treatment groups to identify and compare device-related adverse events in the two treatment groups to identify other patient factors associated with stent failure and to compare survival between the Viaduct and polyethylene stent groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None