Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study

Institut Paoli-Calmettes72 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Malignant Biliary Obstruction

Interventions

12-mm metallic biliary stentDEVICE

Metallic biliary stent, covered or uncovered,KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Time to recurrent biliary obstruction (RBO)

RBO is defined as the time from the prosthesis deployment to until the first biliary stent obstruction (patency

Time frame: 12 months