Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection
试验速览
- 阶段
- 不适用
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- time of operation
研究概览
简要总结
Recent clinical experience showed that laparoscopic hepatectomy has advantages of minimally invasive compared to open liver resection, however, laparoscopic liver resection is still difficult and risky. Currently it is only carried out in a few large medical centers with slow development. The related research studies were retrospective analysis, there were no prospective randomized controlled multi-center study reported. Because of its relatively simple anatomical advantages, left liver seems to be as the best platform to ensure maximum safety and feasibility of prospective randomized study for laparoscopic hepatectomy .This project intends to carry out a prospective randomized controlled multi-center study to look for evidence of safety, efficacy and minimally invasive of laparoscopic left liver resection, evaluate the long-term efficacy including overall survival, disease-free survival as well as time to disease recurrence for the left liver carcinoma.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Child-pugh A-B
- •Primary hepatocellular carcinoma of the left liver lobe
- •Tumor size ≤5cm in diameter
排除标准
- •Significant abnormal liver function
- •Significant abnormal Heart function
- •Significant abnormal lung function
- •Significant abnormal kidney function
结局指标
主要结局
time of operation
时间窗: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
status of the resection margins
时间窗: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
bile leakage
时间窗: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
abdominal adhesion
时间窗: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
amount of bleeding
时间窗: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
次要结局
- overall survival(Participants will be followed for 5 years.)
- disease-free survival(Participants will be followed for 5 years.)
- time to disease recurrence(Participants will be followed for 5 years.)
研究者
Ya-jin Chen
Chief of the division of hepatobiliary surgery
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
