NCT01014390已完成3 期
A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 13
- 主要终点
- Stent Removability
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age 18 or older
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- •Chronic pancreatitis or prior liver transplantation or prior other abdominal surgery (to include cholecystectomy)
- •Indicated for ERCP procedure with stent placement for: Symptomatic bile duct stricture (i.e. obstructive jaundice, persistent cholestasis, acute cholangitis) confirmed by cholangiogram and/or Bile duct stricture confirmed by cholangiogram and/or Exchange of prior plastic stent(s) for management of benign stricture
排除标准
- •Placement of the stent in strictures that cannot be dilated enough to pass the delivery system
- •Placement of the stent in a perforated duct
- •Placement of the stent in very small intrahepatic ducts
- •Patients for whom endoscopic techniques are contraindicated
- •Biliary stricture of malignant etiology
- •Biliary stricture of benign etiology other than chronic pancreatitis or liver transplant anastomosis or other abdominal surgery
- •Stricture within 2 cm of duct bifurcation
- •Symptomatic duodenal stenosis (with gastric stasis)
- •Prior biliary self-expanding metal stent
- •Suspected stricture ischemia based on imaging of hepatic artery occlusion or endoscopic evidence of biliary cast syndrome
- •Known bile duct fistula
- •Known sensitivity to any components of the stent or delivery system
- •Participation in another investigational study within 90 days prior to consent or during the study
- •Additional Specific to Chronic Pancreatitis Patients:
- •Developing obstructive biliary symptoms associated with an attack of acute pancreatitis
- •Additional Specific to Post-Abdominal Surgery Patients:
- •History of hepatectomy
- •History of liver transplant
- •Additional Specific to Liver Transplant Patients:
- •Live donor transplantation
研究组 & 干预措施
WallFlex Biliary RX FC Stent System
Experimental
The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.
干预措施: WallFlex Biliary RX Fully Covered Stent System (Device)
结局指标
主要结局
Stent Removability
时间窗: At stent removal
Defined as ability to remove the stent endoscopically without serious stent removal related adverse events as assessed from the time of stent removal to 1month post-stent removal.
次要结局
未报告次要终点
研究者
研究点 (13)
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