A Randomized Controlled Trial of Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
Hepatectomy is still the treatment of choice for hepatocellular carcinoma. Part of the patients may present portal vein tumor thrombus (PVTT) after resection. PVTT might lead to upper gastrointestinal bleeding and worsening of hypersplenism which will endanger the life of the patients. PVTT also plays the centre role of recurrence and metastasis of HCC. There is no standard treatment for PVTT yet. We aim to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT.
详细描述
Hepatectomy is still the treatment of choice for hepatocellular carcinoma, but the prognosis is not agreeable. Part of the patients may present portal vein tumor thrombus (PVTT) after resection. PVTT might further increase the pressure of portal vein and lead to upper gastrointestinal bleeding and worsening of hypersplenism which will endanger the life of the patients. PVTT also plays the centre role of recurrence and metastasis of HCC. There is no standard treatment available now for PVTT yet. TACE is mostly often used to treat the PVTT. We aim to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT.
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
- •PVTT after liver resection was diagnosed with at least two types of imaging findings, such as CT, MRI or color doplor findings.
- •The functions of the kidney, heart and lung and the routine test of the blood are in good condition.
- •The liver function is of grade A or B in Child-Pugh classification.
- •The patient is eligible of the trial and will show consent to the test.
排除标准
- •any of the parameters. WBC less than 2000/ml, Hb less than 90g/L or PLT less than 50000/ml.
- •disfunction of the heart, lung, kidney, or brain.
- •any other disease might affect the trial .
- •the patients would not sign the consent to the trial.
研究组 & 干预措施
survival rate (TACE)
to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT
干预措施: TACE (Drug)
survival rate (TACE plus laser ablation)
to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT
干预措施: TACE (Drug)
survival rate (TACE plus laser ablation)
to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT
干预措施: Laser ablation (Procedure)
结局指标
主要结局
overall survival
时间窗: 2010
次要结局
- the changes of the PVTT(2010)
研究者
ShenFeng
vice president of the Eastern Hepatobiliary Surgery Hospotal
Eastern Hepatobiliary Surgery Hospital