Biliary Strictures
Conditions
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.
Interventions
For use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures
DEVICEWallFlex™ Biliary RX Partially Covered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
DEVICEWallFlex™ Biliary RX Uncovered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stent Functionality | 24 Months | Stent functionality defined as absence of unscheduled biliary reintervention for the management of biliary obstructive symptoms during study stent indwell |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Indication for stent placement | 12 Months | Distribution of indications for stent placement |
| Stent types | 12 Months | Distribution of stent types by indication for stent placement |
| Biliary obstructive symptoms | 24 Months | Biliary Obstructive Symptom assessment at all biliary reinterventions compared to baseline |
| Technical success at placement | 24 Months | Technical success at placement defined as ability to deploy the stent in a satisfactory position |
| Serious adverse events | 24 Months | Occurrence of serious adverse events related to the stent and/or the stent placement and/or stent removal procedures as applicable |
| Neoadjuvant therapy | 24 Months | Ability to complete the planned neoadjuvant therapy regimen without interruptions |
| Stricture resolution | 24 Months | Stricture resolution defined as absence of a stricture requiring drainage (restenting) at time of stent removal |
| Time to recurrence of original stricture | 24 Months | Time to recurrence of original stricture |
| Resolution of the indication for stent placement | 24 Months | Resolution of the indication for stent placement |
| Technical success at removal | 24 Months | Technical success at removal (as applicable) defined as ability to remove the stent endoscopically without serious adverse device removal related event |
Countries
Canada
Outcome results
None listed