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

A Randomized Trial Comparing a Winged Perimeter Stent and Traditional Polyethylene Plastic Stent in the Management of Malignant Distal Biliary Strictures

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.

Study Overview

• Status: Completed
• Conditions: Malignant Tumor of Extrahepatic Bile Duct
• Intervention / Treatment: Device: WInged perimeter biliary stent insertion (Viaduct); Device: traditional polyethylene stent insertion (Cotton Huibregtse)

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • St Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Cotton Huibregtse Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent patency time	Time to bile duct re-obstruction	six months post stent insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Etiology of stent failure	Usually occlusion or migration	six months post stent insertion
Compare number of patients with device related adverse events	Comparing both procedural and delayed complications of stents	six months post stent insertion
Identify patient factors associated with stent failure		six months post stent insertion
Survival between the two groups	Measurement in months of survival post diagnosis	six months post stent insertion

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Jennifer J Telford, MD MPH FRCPC, University of British Columbia

Publications and helpful links

General Publications

• Raju GS, Sud R, Elfert AA, Enaba M, Kalloo A, Pasricha PJ. Biliary drainage by using stents without a central lumen: a pilot study. Gastrointest Endosc. 2006 Feb;63(2):317-20. doi: 10.1016/j.gie.2005.07.053.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2012
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: January 16, 2012
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (ESTIMATE): January 23, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: cancer; ERCP; biliary stricture; viaduct
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: H10-02829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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