Clinical trial NCT02261623: Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry
Official title: Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Strictures
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-10-10
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Stent Functionality
timeFrame: 24 Months
Secondary outcomes:
measure: Serious adverse events
timeFrame: 24 Months
measure: Indication for stent placement
timeFrame: 12 Months
measure: Stent types
timeFrame: 12 Months
measure: Biliary obstructive symptoms
timeFrame: 24 Months
measure: Technical success at placement
timeFrame: 24 Months
measure: Technical success at removal
timeFrame: 24 Months
measure: Neoadjuvant therapy
timeFrame: 24 Months
measure: Stricture resolution
timeFrame: 24 Months
measure: Time to recurrence of original stricture
timeFrame: 24 Months
measure: Resolution of the indication for stent placement
timeFrame: 24 Months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Providence Health - St. Paul's Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria General Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Oakville
country: Canada
facility: Oakville-Trafalgar Memorial Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Greenfield Park
country: Canada
facility: Hopital Charles Le Moyne
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Hopital Saint-Luc
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS Hotel Dieu
state: Quebec
Study officials:
affiliation: University of Alberta
name: Gurpal Sandha, MD
role: PRINCIPAL_INVESTIGATOR
References: