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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palliation | Palliative treatment of biliary strictures produced by malignant neoplasms, no intended surgery |
| |
| Curative intent surgery | Palliative treatment of biliary strictures produced by malignant neoplasms, prior to curative intent surgery, with or without neoadjuvant therapy |
| |
| Benign biliary strictures | Treatment of benign biliary strictures |
| |
| Other indication | Other indication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WallFlex™ Biliary RX Fully Covered Stent System RMV | Device | For use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have been diagnosed with a blockage of the bile duct which may be caused by a benign or malignant biliary stricture.
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| Name | Affiliation | Role |
|---|---|---|
| Gurpal Sandha, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter Lougheed Centre | Calgary | Alberta | T2N 2T9 | Canada | ||
| Royal Alexandra Hospital |
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| WallFlex™ Biliary RX Partially Covered Stent System | Device | For use in the palliative treatment of biliary strictures produced by malignant neoplasms. |
|
| WallFlex™ Biliary RX Uncovered Stent System | Device | For use in the palliative treatment of biliary strictures produced by malignant neoplasms. |
|
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 |
| Edmonton |
| Alberta |
| T5H 3V9 |
| Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2P4 | Canada |
| Providence Health - St. Paul's Hospital | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Victoria General Hospital | Victoria | British Columbia | V8R 1J8 | Canada |
| Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Oakville-Trafalgar Memorial Hospital | Oakville | Ontario | L6J 3L7 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Hopital Charles Le Moyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| CHUM - Hopital Saint-Luc | Montreal | Quebec | H2X 3J4 | Canada |
| CHUS Hotel Dieu | Sherbrooke | Quebec | J1K 2R1 | Canada |