A Randomized Controlled Trial of Radiofrequency Ablation Assisted Hepatectomy and Hepatectomy Alone in the Treatment of Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Recurrence-free Survival
研究概览
简要总结
RFA has become a standard method in the treatment of small HCC(≤2 cm) due to its ease of use, safety, cost-effectiveness, and minimal invasiveness. It can ablated and blocked the small vessels while destroyed the tumor cell in situ. Surgical resection is the most widely accepted treatment for the patients with advanced hepatocellular carcinoma in the Asian countries. But the effectiveness of hepatectomy was depressed because of the high recurrence rate. The spreading of the cancer cell along the portal vein or the hepatic vein system during the operation account for the tumor recurrence. Using RFA to ablate and block the small vessels around the tumor before resection will reduce the spreading of the cancer cell. Investigators hypothesized that the RFA assisted hepatectomy might result in lower recurrence rate than hepatectomy alone in the treatment of advanced HCC. Thus, the purpose of this study was to prospectively compare the effects of RFA assisted hepatectomy with hepatectomy alone for the treatment of advanced 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
- None
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
- •Diagnosis of HCC confirmed at our hospital.
- •Intrahepatic tumor count no higher than 3 and a minimum tumor diameter > 3 cm, but no more than 8cm.
- •Liver function of Child-Pugh Class A or B.
- •Tumors lacked intrahepatic and extrahepatic metastasis.
- •Tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches.
- •Indocyanine green retention at 15 minutes (ICG-15) of <10%.
- •No evidence of coagulopathy: platelet count > 50 × 109/L and a prolonged prothrombin time of < 5 seconds.
- •No other anti-tumor therapy received before the treatment. -
排除标准
- •Patients met the inclusion criteria but declined to participate.
- •Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites.
- •Patients whose permanent pathology after treatment suggested metastatic liver cancer or primary liver cancer of another tissue type.
研究组 & 干预措施
Hepatectomy
Using Hepatectomy for the treatment of advanced HCC
干预措施: Hepatectomy (Procedure)
RFA assisted Hepatectomy
Ablating the liver tissue around the tumor before hepatectomy.
干预措施: RFA assisted Hepatectomy (Procedure)
结局指标
主要结局
Recurrence-free Survival
时间窗: 2 years
次要结局
- Overall Survival(2 years)
研究者
fengkai
Institute of Hepatobiliary Surgery
Southwest Hospital, China