A Prospective Randomized Control Trail of Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of the study is to observe the curative effect and safety of laparoscopic versus open liver resection for hepatocellular carcinoma.
详细描述
Liver resection is the most important treatment of hepatocellular carcinoma (HCC). Open hepatectomy was regarded as a giant surgery because of its big incision, influence of the liver function, and long hospital stay. Laparoscopic hepatectomy was widely used since it was reported by Reich in 1991. With the constant innovation of laparoscopic technique and equipment, there is no penalty area in laparoscopic hepatectomy. The Louisville consensus proposed that the best indication for laparoscopic hepatectomy was the tumor diameter < 5cm, located in segment II-VI.
Previous studies shows that compared with the open surgery, laparoscopic hepatectomy has the advantages of shorter operation time, less bleeding, shorter hospitalization time. The mortality, mobility, the overall survival and the disease-free survival was same in these two groups.
So far, however, the curative effect and safety research of laparoscopic versus open liver resection for HCC is limited to retrospective study and case-control study. A prospective, randomized, controlled study is urgently needed.
This study was proceeded to observe the curative effect and safety of laparoscopic versus open liver resection for HCC.
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
- Single (Investigator)
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
- •Diagnosis was HCC
- •The tumor was located in segment: II, III, IVb, V, VI
- •The tumor diameter < 5cm
- •Without thrombosis in the portal vein, hepatic vein or bile duct
- •Without intrahepatic and systemic metastasis
- •The Child-pugh score was A-B7
- •The ASA（American Society of Anesthesiologists） score was I-III
- •The patient age was between 18-75
- •Sign the informed consent, and can fully understand the research content
排除标准
- •Have surgery contraindications
- •Pregnant or lactating women
- •The Child-pugh score was B8-C
- •The ASA（American Society of Anesthesiologists） score was IV-V
- •With other malignant tumor
- •With mental illness
- •Participated in other clinical trials in the last three months
- •Underwent other treatments(chemotherapy or radiotherapy) before operation
结局指标
主要结局
Overall survival
时间窗: 5 years
The overall survival of HCC patients after operation
次要结局
- Disease free survival(5 years)
- Incidence of postoperative complications(1 month)
研究者
Lunxiu Qin
Department of general surgery, Huashan hospital
Fudan University