Multipolar Radiofrequency Ablation for the Treatment of Hepatocellular Carcinoma Using Classical Intranodular Technique Versus Extra Nodular Technique So-called "No Touch" Technique: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- 2 years global (local+distant) recurrence rate
研究概览
简要总结
The primary purpose of the trial is to demonstrate that at least a 40% drop of recurrence rate can be achieve in hepatocellular carcinoma patients treated with no touch multipolar radiofrequency ablation technique compared to those treated with usual intranodular multipolar technique.
详细描述
206 patients with hepatocellular carcinoma(s) including up to three nodules measuring up to four cm in diameter, will be randomized in two therapeutic legs: multipolar no touch radiofrequency versus multipolar intra nodular radiofrequency. Patients previously treated for hepatocellular carcinoma will not be enrolled in the study. Diagnostic of hepatocellular carcinoma will be based on American Society of Liver Diseases guide line. Early response to the treatment will be assessed one month after the radiofrequency ablation procedures (up to three in case of incomplete necrosis) with dynamic contrast medium enhanced CT or MRI liver examinations. For the follow up dynamic contrast medium enhanced CT or MRI liver examinations will be performed every three months.
The trial will last for 73 months including 45 months for the recruitment of patients. The main criteria of judgement will be the 2-years recurrence rate.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults > 18 years old, holder of up to 3 nodules less than 4 cm in diameter
- •Diagnosis of hepatocellular carcinoma according to American Society of Liver Study non invasive criteria or based on histological proof
- •Non invasive diagnosis of cirrhosis according to French Haute Authority of illness guideline or based on histological proof
- •No previous treatment for hepatocellular carcinoma
- •Multidisciplinary decision of treatment by radiofrequency ablation
排除标准
- •Adult patient under guardianship or trusteeship, homeless
- •Patient with potentially short term life-threatening serious co-infection (apart from viral B or C, or VIH co-infection)
- •Pregnant or breastfeeding woman
- •Patient for whom regular follow-up is impossible whatever the cause
- •Contra indication to general anaesthesia
- •Technical impossibility to perform the procedure under ultrasound guidance
- •Boundary of the tumor located at less than 1 cm distance from colonic wall or main biliary tract (main right or left bill ducts and common bill duct)
- •Tumor invisible with ultrasound
- •Lack of safe percutaneous course which can be planned
- •Tumor in which more than four biopsies pass were previously performed (cumulated during one or several previous biopsies sessions)
- •Contra indication to perform CT or MRI with contrast medium (GADOLINITE or iodinate) intravenous injection
- •Child-Pugh B or C cirrhosis (apart from the transitory liver failures in the setting of acute hepatitis related to alcohol abuse)
- •Total detachment of the anterior face of the liver from internal abdominal wall due to abundant ascites.
- •Prothrombin activity < 50 %
- •Platelet count <40 .10 3/ml
- •Platelet dysfunction or congenital impaired blood coagulating
研究组 & 干预措施
extranodular "no touch" multipolar RFA
干预措施: Radiofrequency ablation (Procedure)
intranodular multipolar RFA
干预措施: Radiofrequency ablation (Procedure)
结局指标
主要结局
2 years global (local+distant) recurrence rate
时间窗: 2 years
次要结局
- 2 years local recurrence rate(2 years)
- 2 years distant recurrence rate(2 years)
- Primary treatment effectiveness (assessed 1 month after completion of treatment course which can include up to 3 radiofrequency ablation (RFA) procedures performed monthly)(2 years)