NCT01410591已完成不适用
The Effect of TIPS With 8- or 10-mm Covered Stent for Preventing Variceal Rebleeding in Cirrhotic Patients.
Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2012年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Incidence of shunt dysfunction.
研究概览
简要总结
The purpose of this study is to determine whether transjugular intrahepatic portosystemic shunt (TIPS) with 10-mm covered stent is associated with lower shunt dysfunction in comparing TIPS with 8-mm covered stent in cirrhotic patients with at least one episode of variceal bleeding.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotic patients with at least one episode of variceal bleeding
- •No active bleeding within 5 days before TIPS
- •Child-Pugh score ≤13
- •Signed written informed consent
排除标准
- •An age <18 years or >75 years
- •With TIPS contraindications
- •Past or present history of hepatic encephalopathy
- •Pregnancy or breast-feeding
- •Hepatic carcinoma and/or other malignancy diseases
- •Spontaneous bacterial peritonitis
- •Uncontrollable hypertension
- •Serious cardiac or pulmonary dysfunction
- •Renal failure
- •Portal vein thrombosis
- •History of organ transplantation
- •History of HIV (human immunodeficiency viruses) infection
结局指标
主要结局
Incidence of shunt dysfunction.
时间窗: 2 years
次要结局
- Incidence of hepatic myelopathy(2 years)
- Incidence of variceal rebleeding(2 years)
- Incidence of hepatic encephalopathy(2 years)
- Survival(2 years)
研究者
Guohong Han
Head of Department of Digestive Interventional Radiology
Air Force Military Medical University, China
研究点 (1)
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