Prospective Evaluation of Wing Biliary Stent Patency in Patients With Benign Biliary Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Count of Participants With Stent Patency at 90 Days
研究概览
简要总结
Evaluation of ERCP with placement of a winged plastic biliary stent without a lumen for management of benign biliary strictures.
详细描述
ERCP with plastic stent placement for resolution of biliary obstruction has been the method of choice for many years. However, stent obstruction is a major limitation of this approach. Studies have shown that the conventional tubular type polyethylene stents (CS) with side holes accumulate significant sludge and their mean patency is approximately 90 days.
Thus patients requiring longer term stenting need to undergo stent exchanges every 2-3 months.
Recently, a stent with a star-shaped cross-section has been developed for biliary applications. This FDA approved biliary Wing stent (WS) (ViaDuct™) is a novel plastic biliary stent that lacks a lumen, and is designed to allow bile to flow on the outside of the stent.
The stent which is star shaped in cross section, channels fluid along its winged perimeter.
It has been proposed that the winged stent design with a lack of central lumen obviates the risk of luminal occlusion and that the risk of occlusion, given the presence of multiple external drainage channels, is smaller. Longer term biliary drainage without the need for stent exchange should therefore be possible with these stents.
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
- 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
- •All patients age 18 or older referred for ERCP for biliary obstruction from stones or benign strictures that have been confirmed based on clinical, laboratory and imaging findings, with an indication for plastic stent placement.
- •One or more biliary stents may be placed during the procedure depending on the indication such as a biliary stricture necessitating multiple stent placements for dilation as the standard of care.
- •Expected patient survival of at least 90 days
- •High likelihood of patient follow-up
- •Patient is able to give a written informed consent
- •Patient is willing and able to comply with the study procedures.
排除标准
- •Patients with cholangitis
- •Patients with bile leak
- •Pregnant patients
- •Patients with any contraindication to endoscopic procedure
- •Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
- •Patients with malignant biliary strictures
研究组 & 干预措施
Winged stent
Placement of Winged stent for management of biliary obstruction. Stent to be placed for 90 days, with laboratory studies and clinical evaluation during this period to assess for stent potency.
干预措施: Winged biliary stent (ViaDuct™) (Device)
结局指标
主要结局
Count of Participants With Stent Patency at 90 Days
时间窗: 90 days after placement of stent
Evaluation of laboratory studies and clinical status to assess for stent patency/evidence of biliary obstruction
次要结局
未报告次要终点
研究者
Subhas Banerjee
Associate Professor of Medicine, Division of Gastroenterology
Stanford University