Prospective Randomized Comparative Study on No-touch Radiofrequency Ablation Treatment of Small Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Recurrence Rate
研究概览
简要总结
Traditional RFA treatment has been a curable therapy for small hepatocellular carcinoma (diameter≤3cm). This technique ablates the tumor via radio frequency by inserting an electrode needle directly into the tumor. This clearly violates no-touch technique based on the principle of surgical oncology. Thus the 1-year recurrence rate of the cancer is up to 30% after the treatment, and the 3-year tumor-free survival rate is only 20% - 40%. No-touch RFA treatment avoids the direct contact with the tumor that can cause the spread of cancer cells in the liver, or the Antrim spread, Therefore it has been suggested that no-touch RFA treatment reduce the recurrence rate after operation in comparison with the traditional RFA treatment. This research project aims at using the prospective randomized comparative method to compare the short-term and the long-term curative effects between no-touch RFA and traditional RFA treatments for small hepatic carcinoma.
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
- •Primary hepatocellular carcinoma, according to the postoperative pathological examination as the standard, or the diagnostic criteria with reference to the 2012 American Association for the Study of Liver Diseases if the pathological evidence is not available;
- •A single tumor with a diameter ≤3cm;
- •The tumor that has not invaded the portal vein, the hepatic vein, or the secondary branch;
- •Liver function classified as Child A or B;
- •Liver reserve function test with ICG-R15 (indocyanine green retention at 15min) ≤30%, and the important organs that can function with the tolerance of RFA or partial hepatectomy;
- •No significant coagulopathy: platelet count > 50,000,000,000 /L, prolonged prothrombin time < 5 seconds;
- •Age 18 - 70 years old;
- •No acceptance of other anti-cancer therapy before the treatment.
排除标准
- •Complication of severe portal hypertension: a history of upper gastrointestinal bleeding, a history of severe hypersplenism, or refractory ascites;
- •Patients with extrahepatic metastasis or lymph node metastasis;
- •Patients with multiple liver tumors found from imaging exam or during the treatment;
- •Patients with pathological examinations showing the other tissue type of liver cancer after the treatment;
- •Patients who expect to receive a liver transplant;
- •Patients whose preoperative imaging exam indicates the tumor close to the gallbladder, hilar major blood vessels, bile ducts and surrounding vital organs, with a potential of serious injury by mistake or serious complications during the treatment.
研究组 & 干预措施
Traditional RFA
Using Traditional RFA for the treatment of small hepatocellular carcinoma
干预措施: Traditional RFA (Procedure)
No-touch RFA
Using No-touch RFA for the treatment of small hepatocellular carcinoma
干预措施: No-touch RFA (Procedure)
结局指标
主要结局
Recurrence Rate
时间窗: 3 years
次要结局
- Recurrence-free Survival Rate(3 years)
- Overall Survival Rate(3 years)
研究者
Yuelong Chai
Candidate of Doctor in Medicine
Southwest Hospital, China