Recurrence Risk Factors of Early-Stage Hepatocellular Carcinoma After Radio Frequency Ablation: a Multi-center Prospective Case-control Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Technical success
研究概览
简要总结
The aim was to investigate the efficacy of radiofrequency ablation (RFA) with a multiple-electrode switching system (MESS) in the treatment of early hepatocellular carcinoma (HCC) and to evaluate the patterns and risk factors of intrahepatic recurrence of HCC after RFA.
详细描述
Percutaneous RFA has become a particularly promising treatment for patients with early HCC. For HCC with a diameter less than 3cm, RFA is becoming an effective topical method for the goal of a complete cure. Although RFA is successful for small HCCs, for HCCs with a diameter larger than 3 to 5 cm, the complete ablation rate is reported to range from 61.3% to 82.5%. These results may be obsolete due to the further development of RFA techniques and instruments. For example, the use of clustered electrodes and an improved motor can provide a higher power, and the multiple-electrode switching system RFA (MESS-RFA) uses various methods to create a sufficient ablation zone, the investigators need to further update the management strategy of the RFA treatment of early HCC.
However, HCC recurrence after RFA is still a significant problem . the investigators divide the intrahepatic recurrence after RFA into local tumor progression (LTP) and intrahepatic distant recurrence (IDR); each type of recurrence has a different pathogenic mechanism and is thought to occur relatively independently . Understanding the pattern and risk factors of recurrence is very important for the development of RFA and its clinical application.
The objective of our multicenter prospective study was to evaluate the efficacy of MESS-RFA as a primary method for treating early HCC, to assess the pattern of intrahepatic recurrence according to the types of recurrence, and to determine the risk factors associated with tumor recurrence and survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •18-70 years old
- •The diameter of single tumor should be no more than 5cm, or multiple tumors(less than 3 loci) should be no more than 3cm. No large vascular invasion, no lymph nodes or extrahepatic metastases
- •The Classification of patients' liver function is Child - Pugh A or B
- •No serious coagulation dysfunction (prothrombin activity < 40% or platelet count < 30000 / mL).
- •No refractory ascites.
- •The patients can be treated with RFA in clinical
- •Primary treatment by RFA should ablate the tumor(s) completely
- •The patients are aware of their condition, the treatment of the HCC, and the risks associated with radiofrequency ablation therapy.
- •The patients participant voluntarily and they will sign the informed consent before the radiofrequency ablation therapy.
排除标准
- •The patients are from abroad, Hong Kong, Macao, Taiwan and other regions, who are impossible to be follow-up
- •The patients who refuse to sign the informed consent
- •Tumor emboli existed in main portal vein, ductus hepatics communis and(or) its primary branch, main hepatic vein and(or) inferior vena cava before operation
- •Extrahepatic metastasis, lymph node metastasis
- •The patients whom accept systemic chemotherapy, preoperative interventional therapy, and(or) other auxiliary treatment
- •The patients with diabetes mellitus, heart disease and(or) other diseases can't tolerate radiofrequency ablation, or influence postoperative follow-up
- •The existence of other type of malignant tumor before or accompanied by HCC
- •Primary treatment by RFA do not ablate the tumor(s) completely
- •Non-primary liver tumor, such as the liver metastatic carcinoma, cholangiocarcinoma, etc
结局指标
主要结局
Technical success
时间窗: up to 5 years
Complete ablation rate
次要结局
- IDR(up to 5 years)
- LTP(up to 5 years)
- Overall survival(up to 5 years)
- IDR-free survival(up to 5 years)
研究者
Yunhua Tan
Instructor
Southwest Hospital, China