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Winged Perimeter Versus Traditional Plastic Biliary Stent for Malignant Bile Duct Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01514214
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : May 2, 2018
Information provided by (Responsible Party):
Jennifer Telford, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Malignant Tumor of Extrahepatic Bile Duct Device: WInged perimeter biliary stent insertion (Viaduct) Device: traditional polyethylene stent insertion (Cotton Huibregtse) Not Applicable

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 and/or biliary biopsy to assess for underlying malignancy. Malignant strictures are usually staged for resectability with computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP) and/or 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing a Winged Perimeter Stent and Traditional Polyethylene Plastic Stent in the Management of Malignant Distal Biliary Strictures
Actual Study Start Date : January 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Winged perimeter stent
Patients who receive the Viaduct stent during ERCP
Device: WInged perimeter biliary stent insertion (Viaduct)
Insertion of a winged perimeter stent. Size to be determined during the ERCP based on findings.
Other Name: Viaduct Stent

Active Comparator: polyethylene stent arm
Patient who receive the traditional polyethylene stent during ERCP
Device: traditional polyethylene stent insertion (Cotton Huibregtse)
insertion of a traditional polyethylene stent during ERCP, size to be determined depending on findings during ERCP
Other Name: Cotton Huibregtse Stent

Primary Outcome Measures :
  1. Stent patency time [ Time Frame: six months post stent insertion ]
    Time to bile duct re-obstruction

Secondary Outcome Measures :
  1. Etiology of stent failure [ Time Frame: six months post stent insertion ]
    Usually occlusion or migration

  2. Compare number of patients with device related adverse events [ Time Frame: six months post stent insertion ]
    Comparing both procedural and delayed complications of stents

  3. Identify patient factors associated with stent failure [ Time Frame: six months post stent insertion ]
  4. Survival between the two groups [ Time Frame: six months post stent insertion ]
    Measurement in months of survival post diagnosis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • > 18 years of age
  • Bile duct stricture confirmed on cholangiography at ERCP
  • Malignant etiology confirmed on histology or cytology
  • Duct stricture is > 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts)

Exclusion Criteria:

  • Unable to obtain consent
  • Unable to tolerate procedure
  • Hilar strictures
  • Known benign biliary strictures and benign strictures confirmed after randomization
  • Circumstances where an alternative biliary stent (pigtail stent or metal stent) is deemed critical by the treating Gastroenterologist

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01514214

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Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 2K5
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Jennifer J Telford, MD MPH FRCPC University of British Columbia

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Responsible Party: Jennifer Telford, Clinical Professor of Medicine, University of British Columbia Identifier: NCT01514214    
Other Study ID Numbers: H10-02829
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jennifer Telford, University of British Columbia:
biliary stricture
Additional relevant MeSH terms:
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