A RCT Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
The study, entitled "RCT study of laparoscopic middle hepatic venous guidance versus conventional ananatomical hemihepatectomy", was designed to compare the efficacy of two different ananatomical hemihepatectomy procedures under laparoscopy.
详细描述
Backgroud & Aim:Hepatectomy is the main way to treat all kinds of liver surgical diseases, which can be divided into anatomic hepatectomy and non-anatomic hepatectomy.Among them, anatomic hepatectomy is suitable for primary liver cancer, hepatolithiasis and other benign and malignant diseases;It can be divided into hepatic venous guidance and non-hepatic venous guidance hepatectomy (traditional ananatomical hepatectomy).The aim of this study was to observe and compare the perioperative period and follow-up results of the two different laparoscopic surgical resection methods, and to provide high-level evidence-based medicine evidence for the selection of surgical methods for laparoscopic anatomical hemihepatectomy.
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)
盲法说明
Two different treatments are conducted on the participant base on the randomized choices
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
- •the site was limited to the patients who were suitable for dissecting hemihepatectomy；
- •the type of disease was limited to hepatocellular carcinoma；
- •the patients were generally able to tolerate anesthesia, the liver reserve function was good, and the patients were suitable for laparoscopic surgery；
- •child-pugh grade A, no severe liver cirrhosis, portal hypertension, no extrahepatic and extrahepatic metastasis and main vascular invasion；
- •the subjects who participated in this study indicated that they were willing to accept the two surgical methods and agreed to be randomly divided into groups during the operation；
- •18 ≤ age ≤ 70, male or female.
排除标准
- •preoperative liver function Child-pugh grade B or C;
- •patients with poor general condition and could not tolerate pneumoperitoneum or anesthesia;
- •patients with severe liver cirrhosis, portal hypertension and lesions invading liver porta;
- •patients with other treatment methods such as radio frequency ablation in addition to dissecting hepatectomy;
- •repeated abdominal operations resulting in severe abdominal adhesion, unable to perform laparoscopic hepatectomy; male and female are not limited
结局指标
主要结局
Survival rate
时间窗: 3 years
follow-up after the surgery every 3 months, to understand statistics 1-year overall survival、3-year overall survival、1-year disease-free survival、3-year disease-free survival
次要结局
- Perioperative results(Duration perioperation(an expected average of 3 days))
- intraoperative parameters(during the operation)
研究者
Shuguo Zheng, MD
Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department
Southwest Hospital, China