NCT01768741Unknown不适用
A Randomized Controlled Trial of Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Total survival time and disease free survival time
研究概览
简要总结
The purpose of this study is to investigate the clinical value of laparoscopic liver resection in the treatment of hepatocellular carcinoma by assessing its Surgical and oncologic outcomes comparing with open liver resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Liver solid tumor, with clinical diagnosis of hepatocellular carcinoma
- •Located at segment Ⅱ、Ⅲ、Ⅳb、Ⅴ or Ⅵ
- •The tumor location and size do not affect the dissection of hepatic hilar region
- •Tumor size less than 10cm
- •Without portal vein tumor thrombus
- •Without intrahepatic or distant metastasis
- •Willingness to participate in the study
- •Able to understand the nature of the study and what will be required of them
- •Body mass index of between 18 and 35
- •Child-Pugh classification of A to B
- •American Society of Anesthesiologists (ASA) grading of I to III
排除标准
- •Pregnant or lactating women
- •Unwillingness to participate
- •Inability to give written informed consent
- •Child-Pugh classification of C
- •ASA grading of IV to V
- •Tumor invasion of the inferior vena cava or confluence part of hepatic vein
- •Decompensated liver cirrhosis
结局指标
主要结局
Total survival time and disease free survival time
时间窗: up to 5 years
次要结局
- Postoperative hospital stay(participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Morbidity and mortality(up to 3 months)
- Time to functional recovery(participants will be followed for the duration of hospital stay, an expected average of 6 days)
- Intraoperative parameters including operation time,pneumoperitoneum time, liver resection time, estimated blood loss,transfusion, as well as number,size and location of the tumor(participants will be followed for the duration of operation, an expected average of 90 min)
- Regulatory T cells and associated cytokines in peripheral blood(up to 5 years)
- Regulatory T cells and associated cytokines in liver cancer、para-carcinoma and healthy liver tissue(7 days)
- Surgical margins(7 days)
- Quality of life(up to 1 year)
研究者
Xiujun Cai
Executive Vice-President
Sir Run Run Shaw Hospital
研究点 (1)
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