A Randomized Controlled Trial of Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
The purpose of this research is to compare short-term and long-term efficacy of laparoscopic hepatectomy and radiofrequency ablation in the Treatment of early hepatocellular carcinoma, and provide the evidence for the choice of surgical method from the pathology and cytology.
详细描述
Background:The aim of this study was to compare the efficacy of laparoscopic hepatectomy(LH) with radiofrequency ablation (RFA) in the treatment of early hepatocellular carcinoma (HCC).
Methods:A total of 110 patients with early HCC with nodular diameters of less than 3 cm and up to three nodules were randomly divided into LH (n=55) and RFA groups (n=55). Outcomes were carefully monitored and evaluated during the 3-year follow-up period.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants and researchers do not understand the test grouping, but the research designer arranges and controls all trials.
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
- •Any gender,18 to 70 years old;
- •Preoperative diagnosis of primary liver clear;
- •No active hepatitis and decompensated cirrhosis;
- •Maximum diameter ≤3cm single nodules or three nodules in diameter and no more than 3cm,did not infringe the portal vein,hepatic vein and inferior vena cava invasion,lymph node or extrahepatic turn;
- •No tumor rupture or bleeding;
- •Child-Pugh class A or B grade,ICG-R15 <14%;
- •No coagulation disorders,platelet count > 50 × 109 / L and prolonged prothrombin time < 5 seconds;
- •Not be including related surgery,radiofrequency ablation (RFA),TACE treatment,no certainty anticancer chemotherapy treatment;supreme absolute contraindications abdominal surgery;
- •Patients generally available,heart and lung function can tolerate surgery, abdominal surgery supreme absolute contraindications;
- •Voluntarily participate in the study,informed consent.
排除标准
- •Age < 18 years or > 70,pregnant and lactating women;
- •Primary liver cancer diagnosis is not clear
- •Liver function assessment:Child-PughC level,liver function reserve situation :ICGR-15> 14%
- •Tumor rupture has occurred,or has the line before surgery,radiofrequency ablation (RFA),TACE or chemotherapy cancer treatment;
- •Tips liver imaging with multiple ( > 3 ) lesion,or tumor diameter> 3 cm, clear portal vein,hepatic vein,inferior vena cava tumor thrombus trunk;
- •Preoperative liver metastasis;
- •Preoperative evaluation of cardiopulmonary dysfunction patients who can not tolerate surgery;
- •Intraoperative exploration has occurred disseminated tumor and / or lymph node metastasis;
- •Exploratory surgery found that non-hepatic primary tumors,such as colorectal metastases,hilar cell carcinoma;
- •Severe upper abdominal adhesions;
- •Postoperative pathological examination of the bile duct cell or mixed cell carcinoma and pathologically confirmed positive margin;
- •Foreign,Hong Kong,Macao,Taiwan and other regions,estimated postoperative difficult to track,followed up.
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, 2-year and 3-year survival, disease-free survival, recurrence rate.
次要结局
- postoperative complications(Duration hospitalization(an expected average of 7 days))
研究者
ChenJian
Associate Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department
Southwest Hospital, China