Malignant Biliary Obstruction
Conditions
Keywords
biliary stent, malignant biliary stenosis
Brief summary
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.
Interventions
DEVICE12-mm metallic biliary stent
Metallic biliary stent, covered or uncovered,KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).
DEVICE10-mm metallic biliary stent
Biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm)
Sponsors
Institut Paoli-Calmettes
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* benign and malignant biliary stricture of the lower or median portion of the main biliary duct with indication of biliary stent placement including pre-operatively drainage * age≥ 18 years old; * Karnofsky score ≥ 40.
Exclusion criteria
* hilar stenosis; * coagulation disorder (PT \<50%, platelets \< 80,000).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recurrent biliary obstruction (RBO) | 12 months | RBO is defined as the time from the prosthesis deployment to until the first biliary stent obstruction (patency |
Countries
France
Outcome results
None listed