Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry

The purpose of this study is to document stent functionality and practice patterns in Canada pertaining to indications for use and stent type selection for self-expanding biliary metal stents (SEMS) when used per standard of practice.

Study Overview

• Status: Completed
• Conditions: Biliary Strictures
• Intervention / Treatment: Device: WallFlex™ Biliary RX Fully Covered Stent System RMV; Device: WallFlex™ Biliary RX Partially Covered Stent System; Device: WallFlex™ Biliary RX Uncovered Stent System

Detailed Description

This study is designed to provide a report of these features related to the use of WallFlex metal biliary stents used per standard of practice in Canada.

• Study Type: Observational
• Enrollment (Actual): 415

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Peter Lougheed Centre
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital
    • Edmonton, Alberta, Canada, T6G 2P4
      • University of Alberta Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • Providence Health - St. Paul's Hospital
    • Victoria, British Columbia, Canada, V8R 1J8
      • Victoria General Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Queen Elizabeth II Health Sciences Center
  • Ontario
    • Oakville, Ontario, Canada, L6J 3L7
      • Oakville-Trafalgar Memorial Hospital
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hopital Charles Le Moyne
    • Montreal, Quebec, Canada, H2X 3J4
      • CHUM - Hopital Saint-Luc
    • Sherbrooke, Quebec, Canada, J1K 2R1
      • CHUS Hotel Dieu

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been diagnosed with a blockage of the bile duct which may be caused by a benign or malignant biliary stricture.

Description

Inclusion Criteria:

• Subject indicated for biliary metal stent placement per local standard of practice
• Age 18 or older
• Willing and able to comply with study procedures and follow-up schedule
• Willing and able to provide written informed consent to participate in study

Exclusion Criteria:

• Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
• Subjects who the investigator deems at risk for device or procedure related complications per the Directions for Use (DFU)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Palliation; Palliative treatment of biliary strictures produced by malignant neoplasms, no intended surgery	Device: WallFlex™ Biliary RX Fully Covered Stent System RMV; For use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures; Device: WallFlex™ Biliary RX Partially Covered Stent System; For use in the palliative treatment of biliary strictures produced by malignant neoplasms.; Device: WallFlex™ Biliary RX Uncovered Stent System; For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Curative intent surgery; Palliative treatment of biliary strictures produced by malignant neoplasms, prior to curative intent surgery, with or without neoadjuvant therapy	Device: WallFlex™ Biliary RX Partially Covered Stent System; For use in the palliative treatment of biliary strictures produced by malignant neoplasms.; Device: WallFlex™ Biliary RX Uncovered Stent System; For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Benign biliary strictures; Treatment of benign biliary strictures	Device: WallFlex™ Biliary RX Fully Covered Stent System RMV; For use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures; Device: WallFlex™ Biliary RX Partially Covered Stent System; For use in the palliative treatment of biliary strictures produced by malignant neoplasms.; Device: WallFlex™ Biliary RX Uncovered Stent System; For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Other indication	Device: WallFlex™ Biliary RX Partially Covered Stent System; For use in the palliative treatment of biliary strictures produced by malignant neoplasms.; Device: WallFlex™ Biliary RX Uncovered Stent System; For use in the palliative treatment of biliary strictures produced by malignant neoplasms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent Functionality	Stent functionality defined as absence of unscheduled biliary reintervention for the management of biliary obstructive symptoms during study stent indwell	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events	Occurrence of serious adverse events related to the stent and/or the stent placement and/or stent removal procedures as applicable	24 Months
Indication for stent placement	Distribution of indications for stent placement	12 Months
Stent types	Distribution of stent types by indication for stent placement	12 Months
Biliary obstructive symptoms	Biliary Obstructive Symptom assessment at all biliary reinterventions compared to baseline	24 Months
Technical success at placement	Technical success at placement defined as ability to deploy the stent in a satisfactory position	24 Months
Technical success at removal	Technical success at removal (as applicable) defined as ability to remove the stent endoscopically without serious adverse device removal related event	24 Months
Neoadjuvant therapy	Ability to complete the planned neoadjuvant therapy regimen without interruptions	24 Months
Stricture resolution	Stricture resolution defined as absence of a stricture requiring drainage (restenting) at time of stent removal	24 Months
Time to recurrence of original stricture	Time to recurrence of original stricture	24 Months
Resolution of the indication for stent placement	Resolution of the indication for stent placement	24 Months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Gurpal Sandha, MD, University of Alberta

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2015
• Primary Completion (ACTUAL): March 31, 2016
• Study Completion (ACTUAL): March 31, 2016

Study Registration Dates

• First Submitted: October 7, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (ESTIMATE): October 10, 2014

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: 90921899