Comparison of Covered and Bare Stent in TIPS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- restenosis/occlusion rate
研究概览
简要总结
Investigators aim to compare the efficacy of 8 mm Fluency covered stent and bare stent in transjugular intrahepatic portosystemic shunt (TIPS) for the treatment of cirrhotic portal hypertension.
详细描述
From January 2006 to December 2010, the covered (experimental group) or bare stent (control group) was used in 131 and 127 patients, respectively. The recurrence rates of gastrointestinal bleeding and refractory hydrothorax/ascites, the cumulative restenosis rates in 1, 2, 3, 4, and 5-years, the incidence rate of hepatic encephalopathy, the rate of secondary interventional therapy, the 1, 2, 3, 4 and 5-year survival rates were compared between the experimental group and the control group.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •portal hypertension patients with defined indications for TIPS treatment;
- •scheduled for elective TIPS; and
- •aged between 18-70 years.
排除标准
- •combined with hepatic encephalopathy before the treatment;
- •combined with portal vein thrombosis;
- •combined with malignant liver tumor or malignancies at the other sites; or
- •combined with hemorrhage of gastrointestinal ulcer.
结局指标
主要结局
restenosis/occlusion rate
时间窗: up to 5 years
The cumulative restenosis rate in 1, 2, 3, 4, or 5-year
次要结局
- recurrence rate of gastrointestinal bleeding(up to 5 years)
- survival rate(up to 5 years)
- rate of secondary interventional therapy(up to 5 years)
- recurrence rate of refractory hydrothorax/ascites(up to 5 years)
- incidence rate of hepatic encephalopathy(up to 5 years)
研究者
Liu Fuquan
Department of Interventional Therapy
Beijing Shijitan Hospital, Capital Medical University