The Prospective, Randomized Case-control(RCT) Research of Laparoscope Anatomical and Aon-anatomical Hepatectomy Treat HCC
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
The purpose of this study is to compare short-term and long-term efficacy of two surgical methods by laparoscopic hepatectomy, and provide the evidence for the choice of surgical method from the pathology and cytology.
详细描述
Background:Hepatocellular carcinoma is the world's most common and most malignant tumor, accounting for more than 90% of primary liver cancer, the incidence ranked fifth of malignant tumors in the world. surgery and comprehensive treatment is recognized by the medical profession Surgical approach, including the open HCC hepatectomy and laparoscopic hepatectomy, minimally invasive surgery is the main theme of the 21st century, and laparoscopy as the one of the elements in the field of minimally invasive surgery which carried out more and more in liver surgery, but which one of the two methods to choice to hepatectomy lack of sufficient scientific evidence.The RCT research of laparoscopic anatomical and non-anatomical hepatectomy for HCC has not been reported at home and abroad; Intervention:We let the 110 patients divide into A, B groups randomly who are meet the inclusion criteria .Group A is Laparoscopic Anatomical Hepatectomy: Anatomy the corresponding liver segment pedicle and hepatectomy along the Glisson fiber sheath.Group B is Laparoscopic Aon-anatomical Hepatectomy:1 to 2 cm along the edge of the tumor complete hepatectomy
Results:
- operation time, intraoperative blood loss, rate of blood transfusion, complications and mortality, postoperative liver function, resection margin, number of micrometastases ,long-term curative effect and survival time were collected and analysed.
- groups t-test ，univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis ，Kaplan-Meier survival analysis，Log-rank survival curves were used.
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 (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
- •(1) both male and female, aged 18 to 70; (2) Hepatocellular carcinoma(HCC)diagnosis is clear preoperative; (3) preoperative liver function evaluation: Child-Pugh => B; (4) the lesions can be anatomical hepatectomy,( Indocyanine Green retention rate of 15 minutes) ICGR-15< 20%, the remaining liver volume is sufficient; (5) hepatic single lesions and tumor size between 3-10 cm, does not Invasion the main vein, hepatic artery and vein and major inferior vena cava, did not occur extrahepatic metastasis, and laparoscopic can complete resection; (6) surgery, radiofrequency ablation (RFA), TACE treatment, radiotherapy and chemotherapy have not been implemented (7) voluntary participation in the study, and informed consent.
排除标准
- •• (1) age <18 years or> 70 years , pregnant or lactating women; (2) HCC diagnosis is not clear; (3) preoperative liver function evaluation: Child-Pugh C grade; (4) ICGR-15> 20%, the remaining liver volume is insufficient (account for standard liver volume <35%); (5) preoperative tumor has ruptured, or has been undergoing surgery, radiofrequency ablation (RFA), transhepatic arterial chemotherapy and embolization(TACE) or radiotherapy and chemotherapy treatment; (6) preoperative examinations showed multiple (>3)liver lesion or tumor diameter <3 or> 10 cm, a clearly major portal vein, hepatic vein, inferior vena vein tumor thrombus; (7) extrahepatic metastasis; (8) cardio-pulmonary function and other diseases can not tolerate surgery; (9) the patient refused to sign the informed consent form; (10) the tumor has spread and / or lymph node metastasis intraoperative found ; (11) intraoperative found not to be the HCC, such as metastatic hepatic carcinoma, hilar cell carcinoma; (12) Histological examinations showed it is cholangio carcinoma, or mixed liver carcinoma; (13) foreign and Hong Kong, Macao, Taiwan or other areas, estimated that difficult to track, follow-up postoperative
结局指标
主要结局
Survival rate
时间窗: 5 years
follow-up after the surgery every 2 months, to understand relapse, death, statistics 1 year, 3-year and 5-year survival, disease-free survival, recurrence rate.
次要结局
- postoperative complications(Duration hospitalization(an expected average of 7 days))
研究者
Shuguo Zheng, MD
Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department
Southwest Hospital, China