The Short-term Efficacy of Novel No-touch Combined Directional Perfusion Radiofrequency Ablation in the Treatment of Small Hepatocellular Carcinoma With Cirrhosis.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The incidence of local tumor progression (LTP)
研究概览
简要总结
To evaluate the short-term efficacy of novel no-touch combined directional perfusion radiofrequency ablation in the treatment of small hepatocellular carcinoma with cirrhosis.
详细描述
Liver cancer is the fourth leading cause of cancer-related deaths globally. Hepatocellular carcinoma (HCC) accounts for 70% to 85% of primary HCC and is the leading cause of death in patients with cirrhosis. We developed a novel no-touch combined directional perfusion radiofrequency ablation system.By inserting two or more electrodes around the tumor and activating them simultaneously.The hypertonic saline solution can be directed into the focal tissue from a lateral pore through a tube within the electrode to provide more uniform and thorough necrosis.The maximum ablation volume was increased while the loss of normal tissue in the non-injection direction was reduced, thus reducing the incidence of postoperative complications. Therefore, the purpose of this study was to evaluate the short-term efficacy of novel no-touch combined directional perfusion radiofrequency ablation in the treatment of small hepatocellular carcinoma with cirrhosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Primary hepatocellular carcinoma with a background of cirrhosis
- •Single shot with diameter ≤ 3cm
- •The tumor did not invade portal vein, hepatic vein trunk and secondary branches
- •Child Pugh A/B
- •ICG-R15 ≤ 30%
- •18-70 years old
- •The follow-up time reached 2 years
排除标准
- •The follow-up time is less than 2 years
- •multiple lesions or diameter > 3cm
- •Previous history of upper gastrointestinal bleeding or severe hypersplenism
- •Patients with extrahepatic or lymph node metastasis
- •Wish to receive liver transplantation and hepatectomy
- •The lesion is adjacent to the gallbladder, important blood vessels and bile ducts in the hilum of the liver and important organs around
- •severe bleeding tendency, platelet count < 50 × 10^9/L, or prothrombin time prolonged > 3s
- •Other anti-tumor therapies were accepted before surgery
结局指标
主要结局
The incidence of local tumor progression (LTP)
时间窗: two-years local tumor progression-free survival
LTP was defined as the appearance of new tumor foci near 2 cm at the ablative margin after the local eradication of all tumor cells with RFA
次要结局
- Tumor-free survival(two-years tumor-free survival)
研究者
fengkai
associate professor
Southwest Hospital, China