Temporary Placement of Fully Covered Self-expandable Metal Stents in Benign Biliary Strictures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Initial success rate of temporary FCMS placement
研究概览
简要总结
Endoscopic treatment of benign biliary strictures can be challenging. Balloon dilation and/or plastic stent placement are currently the most popular techniques. Partially covered self-expandable metallic stents have also shown to be effective but can be difficult to remove. A novel fully covered metallic stent has recently been developed.
The aim of this study was to prospectively evaluate the placement of fully covered self-expandable metallic stents (FCSEMS) in this setting.
详细描述
After inclusion, an endoscopic procedure (ERCP) was performed in all patients in order to place a FCMS across the benign biliary stricture. The FCMS was left in place for 6 months and then extracted during a second ERCP procedure. An opacification was performed to assess the efficacy of stenting. Patients were followed up during one year after FCMS extraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a history of liver transplantation, chronic pancreatitis or biliary surgery
- •impairment of liver function tests such as elevated liver enzymes and/or cholestasis
- •a biliary stricture associated with ductal dilation detected by US, CT or MRI, with a minimum distance of 2cm between the upper stricture's edge and the lower limit of the main biliary confluence or liver hilum .
排除标准
- •an uncertainty about the benign nature of the stricture
- •an intra-hepatic cholangitis and/ or a stricture extending beyond the hilum
结局指标
主要结局
Initial success rate of temporary FCMS placement
时间窗: 6 months
Absence of biliary stricture or as an attenuated stricture on cholangiogram after removal of FCMS
次要结局
- Final success(18 months)
- Stricture recurrence(18 months)
研究者
Chaput Ulriikka
Dr Ulriikka Chaput
Société Française d'Endoscopie Digestive