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Biliary stent allows the drainage of the bile ducts palliatively or preoperatively in the event of malignant biliary stenosis, and a biliary calibration in the event of benign stenosis. Currently, by expert agreement, the diameter is 10-mm for metal stent. Since 2017, larger stents have been marketed in France and are approved for the biliary drainage of benign and malignant biliary stricture. These new 12-mm diameter stent could reduce the risk of recurrent biliary obstruction (RBO) and therefore increase the stent duration. The aim of our study was to compare whether the permeability of 12-mm diameter stent was better than a conventional 10-mm, covered or uncovered prosthesis depending on the indication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12-mm diameter metallic billiary stent |
| ||
| 10-mm diameter metallic billiary stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-mm metallic biliary stent | Device | Metallic biliary stent, covered or uncovered,KEBOMED HILZO 12mm in diameter (length 4 or 6 cm). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to recurrent biliary obstruction (RBO) | RBO is defined as the time from the prosthesis deployment to until the first biliary stent obstruction (patency | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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From April 2017 to April 2018, at the Paoli Calmettes Institute, 24 patients with benign or malignant biliary strictures were treated by placing a metallic biliary stent, covered or uncovered, KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).
"Control" patients, who had benefited from the placement of a biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm) were searched on a database (ConsortConsore®️)extending from January 2016 to March 2018. "Cases" patients were exactly matched in a ratio 1:2 to "control" on the following criteria: age (per decade), sex, pathology responsible for biliary stenosis (i.e., benign or malignant stenosis) and type of stent (i.e., covered/uncovered). When we searched for control patients in our database, the first patient with matching criteria was included.
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| Name | Affiliation | Role |
|---|---|---|
| Fabrice Caillol | Institut Paoli-Calmettes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli Calmettes | Marseille | Bouches Du Rhône | 13273 | France |
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| 10-mm metallic biliary stent | Device | Biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm) |
|