The Safety and Efficacy of a Short Specially Designed Fully Covered Metallic Stent in the Management of Benign Post-surgical Biliary Strictures: a Randomized-controlled Study
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Clinical success
研究概览
简要总结
Post-surgical biliary strictures are common especially after cholecystectomy. Standard treatment involves the performance of multiple procedures over a 1 year period at least using several plastic stents to achieve permanent dilatation of these strictures.
Metallic stents have the theoretical benefit of absence of need of multiple sessions.
These strictures however are frequently very close to the hilum and thus previously considered a contraindication for insertion of metallic stents for the fear of occlusion of the contralateral ducts. Metallic stent migration is also a frequent problem.
The use of a metallic stent that is short and completely intraductal, in theory, should reduce the risk of stent migration.
This is a randomized controlled trial comparing the efficacy and safety of a short metallic intraductal stent to the conventional treatment which is multiple plastic stents. In cases with a stricture reaching or close to the hilum a technique is used to avoid obstruction of the contralateral ducts which is insertion of a 7 French plastic stent alongside the metallic stent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed benign postsurgical biliary stricture by presence of all 3 of the following:
- •Ultrasound imaging or Magnetic resonance cholangiopancreatography (MRCP) showing biliary dilatation, Raised bilirubin and or alkaline phosphatase, History of biliary tree surgery within the previous year
- •Naïve to endoscopic therapy
- •Age > 18 years
排除标准
- •Coagulopathy
- •Inability of patient to adhere to regular follow-up
- •Living-donor liver transplant patients
结局指标
主要结局
Clinical success
时间窗: 6 months after removal of stents
Proportion of patients with Absence of clinical or laboratory evidence of recurrence of biliary obstruction
次要结局
- Technical success(At time of procedure)
- Stricture resolution at end of treatment(After 6 months in the metallic stent group and after 12 or 15 months in the multiple plastic stents group)
- Occurrence of complications(up to 6 months after the last procedure)
研究者
Hany Shehab
Associate professor
Cairo University