Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Time to recurrent biliary obstruction (RBO)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •hilar stenosis;
- •coagulation disorder (PT <50%, platelets < 80,000).
结局指标
主要结局
Time to recurrent biliary obstruction (RBO)
时间窗: 12 months
RBO is defined as the time from the prosthesis deployment to until the first biliary stent obstruction (patency
次要结局
未报告次要终点