NCT00433771已完成3 期
A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 10
- 主要终点
- Adequate Clinical Palliation of the Biliary Obstruction
研究概览
简要总结
The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.
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
- •Clinical symptoms of biliary obstruction
- •Inoperable extrahepatic biliary obstruction by any malignant process
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
排除标准
- •Participation in an Investigational Study within 90 days prior to date of patient consent
- •Strictures that cannot be dilated enough to pass the delivery system
- •Perforation of any duct within the biliary tree
- •Presence of a metal biliary stent
- •Presence of any esophageal or duodenal stent
- •Patients for whom endoscopic procedures are contraindicated
- •Patients with known sensitivity to any components of the stent or delivery system
- •Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver
- •Patients with an anticipated life expectancy of < 3 months
研究组 & 干预措施
WallFlex Biliary Fully Covered stent
Experimental
Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
干预措施: WallFlex™ Biliary Fully Covered Metal Stent placement (Device)
结局指标
主要结局
Adequate Clinical Palliation of the Biliary Obstruction
时间窗: 6 months
Adequate clinical palliation of the biliary obstruction as demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first in the evaluable subject cohort of 55 patients.
次要结局
- Technical Success(At treatment)
- Ability to Successfully Remove a Stent Upon Removal Attempt(6 months)
- Re-interventions(Until 6 months or death)
- Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms(1 Month)
- Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms(3 months)
- Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms(6 months)
- Bilirubin Level Reduction(1 month)
- Stent Patency at 1 Month(1 month)
- Stent Patency at 3 Months(3 Months)
- Stent Patency at 6 Months(6 Months)
- Time to Stent Occlusion(Until 6 Months or death)
- Number of Device-Related Adverse Events(Until 6 months or death)
研究者
研究点 (10)
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