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

NCT01514214 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2018-05-02

No results posted yet for this study

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.

Conditions

  • Malignant Tumor of Extrahepatic Bile Duct

Interventions

DEVICE

WInged perimeter biliary stent insertion (Viaduct)

Insertion of a winged perimeter stent. Size to be determined during the ERCP based on findings.

DEVICE

traditional polyethylene stent insertion (Cotton Huibregtse)

insertion of a traditional polyethylene stent during ERCP, size to be determined depending on findings during ERCP

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Jennifer J Telford, MD MPH FRCPC · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-06-30
Completion
2016-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01514214 on ClinicalTrials.gov