Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Survival time
研究概览
简要总结
The purpose of this study is to evaluate the long-term efficacy and safety of surgical resection compared with best supportive care in patients with resectable hepatocellular carcinoma (HCC) with portal venous thrombus (PVTT) in the first branch of portal vein.
详细描述
Advances in surgical techniques have made it possible to remove all macroscopic tumors in more hepatocellular carcinoma (HCC) patients with portal venous thrombus (PVTT). However, the benefit of such surgery remains largely controversial. On one hand, many clinicians believe that surgical resection offers the only chance for long term survival. Many studies reported a median survival of 6-40 months after liver resection and thrombectomy, and some cases achieved long term survival.On the other hand, the strength of evidences arising from these studies was widely questioned because of their retrospective nature and study design. Most of them were single arm cohort study. A few studies used control groups consisted of patients with unresectable HCC and PVTT underwent transarterial chemoembolization. This led to obvious selection bias. Because patients with unresectable HCC and PVTT have a much poorer prognosis compared with resectable disease because of more widespread tumor focus and less residual liver, even if their baseline characters are comparable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •The diagnosis of HCC was made according to AASLD guidelines
- •Main tumor ≥ 7 cm
- •Imaging confirmed the presence of PVTT in the first branches but not
- •Extend into the main trunk of portal vein
- •Eastern Co-operative Group performance
- •Resectable disease
排除标准
- •Child-Pugh class B or C liver cirrhosis
- •An American Society of Anesthesiologists (ASA) score ≥ 3
- •Extrahepatic metastasis
- •Patients had access to sorafenib.
研究组 & 干预措施
Resection arm
Liver resection Plus Thrombectomy
干预措施: Liver resection plus Thrombectomy (Procedure)
Best support care arm
Best supportive care
结局指标
主要结局
Survival time
时间窗: 5-years
次要结局
- Number of Adverse Events(30 days)
研究者
Shi Ming
Professor
Sun Yat-sen University
