Anatomy-based Resection or Margin-based Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- prognosis
研究概览
简要总结
Anatomical liver resection was widely accepted as first line curative therapy for hepatocellular carcinoma. However, number of retrospective clinical studies showed no priority of anatomical resection for hepatocellular, compared with non-anatomical resection.
Surgical resection margin is a essential factor that may affect tumor prognosis. It is controversial whether adequate liver resection margin is associated with improved survival outcome in patients with hepatocellular.
There was few prospective clinical trial to investigate whether anatomical liver resection is superior to non-anatomical resection or liver resection with adequate margin is superior to that with inadequate margin. This prospective clinical trial aims at fix these issues.
详细描述
In the anatomical liver resection group, liver segmentectomy or lobectomy is performed to insure curative resection (R0 resection). The region of liver resected is based on the anatomy or portal vein and hepatic vein. The liver pedicle of the tumor located lobe is exposed and dissected, which is principle to perform anatomical liver resection.
In the non-anatomical liver resection group, the liver parenchyma transection is around 0-2 cm from the tumor margin, according to tumor size and location.
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
- 17 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with hepatocellular carcinoma of BCLC stage A
- •liver function Child-pugh A
- •normal indocyanine green retention rate
- •adequate liver remnant
排除标准
- •age less than 17 y or older than 65 y
- •unresectable liver cancer
- •intraoperative ablation
- •contraindication for liver resection
- •preoperative treatment for hepatocellular
- •active hepatitis
- •multi-original tumors
- •mixed liver cancer (hepatocellular carcinoma and cholangiocellular carcinoma)
- •tumor recurrence
研究组 & 干预措施
anatomical liver resection
resect the tumor located liver segment or lobe
干预措施: anatomical liver resection (Procedure)
resection margin based liver resection
non-anatomical liver resection, but insure adequate resection margin
干预措施: anatomical liver resection (Procedure)
结局指标
主要结局
prognosis
时间窗: 5 years
3 year and 5 year overall survival and disease free survival
次要结局
- postoperative recovery(30 days postoperatively)
- hospital stay(60 days postoperatively)
研究者
Xiaoping Chen
Professor and Chairman
Huazhong University of Science and Technology