TIPS Versus Endoscopic Therapy for the Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- All-cause rebleeding or all-cause death
研究概览
简要总结
portal vein thrombosis may be a negative prognostic marker of variceal bleeding in liver cirrhosis. Compared with conventional endoscopic and pharmacological therapy, transjugular intrahepatic portosystemic shunt may further improve the outcomes of portal vein thrombosis in liver cirrhosis with variceal bleeding.
详细描述
Portal vein thrombosis may be a negative prognostic marker of variceal bleeding in liver cirrhosis. Compared with conventional endoscopic and pharmacological therapy, transjugular intrahepatic portosystemic shunt may further improve the outcomes of portal vein thrombosis in liver cirrhosis with variceal bleeding. However, the safety of transjugular intrahepatic portosystemic shunt remains uncertain in patients with portal vein thrombosis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TIPS group
Transjugular intrahepatic portosystemic shunt
干预措施: Transjugular intrahepatic portosystemic shunt (Procedure)
ET & drugs groups
- Endoscopic therapy.
- Non-selective beta blockers.
- Anticoagulation therapy.
干预措施: Non-selective beta blockers (Drug)
ET & drugs groups
- Endoscopic therapy.
- Non-selective beta blockers.
- Anticoagulation therapy.
干预措施: Endoscopic therapy (Procedure)
ET & drugs groups
- Endoscopic therapy.
- Non-selective beta blockers.
- Anticoagulation therapy.
干预措施: Anticoagulation (Drug)
结局指标
主要结局
All-cause rebleeding or all-cause death
时间窗: 3 years
Cumulative incidence of all-cause rebleeding or all-cause death
次要结局
- Hepatocellular Carcinoma(3 years)
- Portal vein recanalization(3 years)
- Other decompensations of portal hypertension(3 years)
- adverse events of treatment(3 years)
- Quality of life(3 years)
- Overall survival(3 years)
研究者
Guohong Han
Professor
Xi'an International Medical Center Hospital