NCT01236339终止不适用
The GORE® VIATORR® TIPS Endoprosthesis Versus Large-Volume Paracentesis for the Treatment of Ascites in Patients With Portal Hypertension
W.L.Gore & Associates2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Transplant-free Survival
研究概览
简要总结
The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival compared to LVP alone in patients who have cirrhosis of the liver with portal hypertension and difficult to treat ascites.
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
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> Patient has cirrhosis of the liver with portal hypertension
- •> Patient has difficult to treat ascites
- •> Patient is 18 years or older and <70 years old at randomization
- •> Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
- •> Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study.
排除标准
- •> Patient has more than 6 large volume paracenteses within 90 days prior to randomization
- •> Patient is contraindicated for TIPS placement
- •> Patient has had previous TIPS placement
结局指标
主要结局
Transplant-free Survival
时间窗: Through 24 months
Time from randomization to death from any cause prior to transplant. Subjects who undergo liver transplant will be censored at the time of transplant. Subjects without an event will be censored at the date of last follow-up. * Note: The outcome entered below is the number of participants who were either alive or had a liver transplant at time of study termination.
次要结局
- Overall Survival(Through 24 months)
- Time to Transplant(Through 24 months)
- Frequency of Paracentesis(Through 24 months)
- Frequency of Hepatic Encephalopathy(Through 24 months)
- Procedural Success(Time of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants))
- Liver Disease Complications (Adverse Events)(Through 24 months)
研究者
研究点 (2)
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