Prospective Randomized Controlled Study Comparing Response and Recurrence Rates Following Percutaneous Microwave Coagulation Therapy (MCT) Versus Percutaneous Radiofrequency Ablation (RFA) in Patients With Chronic Liver Disease and Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Time to disease progression according to American Society of Interventional Radiology criteria
研究概览
简要总结
To date, the majority of studies that have evaluated the efficacy of microwave ablation (MWA) in the treatment of hepatocellular carcinoma (HCC) lesions in cirrhotic patients and compared its efficacy with that of percutaneous radiofrequency ablation (RFA) for local recurrence and survival have been retrospective. There have been no prospective randomized studies comparing percutaneous microwave ablation (PMWA) with RFA for ablated tumour volume, the response after one session, local recurrence rates in the first year, complication rates and survival at 3 and 5 years for HCC lesions > 2 cm in patients with Child-Pugh A and B cirrhosis. The hypothesis the investigators wish to explore is that though the 2 methods are equivalent for lesions ≤ 2 cm, MWA could show better efficacy with a similar risk for lesions > 2 cm and for lesions close to vessels ≥ 3 mm in diameter, as shown in retrospective studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patient who have been informed about the research and given their oral consent
- •Patients with national health insurance cover
- •Patients ≥ 18 years
- •≤ 3 CHC lesions ≤ 4 cm, with a maximum of 3 lesions with a diagnosis of HCC based on histology, or according to European Society for the Study of the Liver (EASL) criteria
- •Chronic liver disease or cirrhosis with a Child-Pugh score between 5 and 8 points
- •Contra-indication for surgical resection at the time of the therapeutic decision made during a multidisciplinary meeting
排除标准
- •Informed consent not obtained (refusal of patient or patient lacking discernment)
- •Kidney failure with creatinine clearance < 30 ml/min thus preventing the injection of contrast for the initial or follow-up radiological imaging
- •Presence of a malignant tumour other than the HCC at the time of the diagnosis, unless a basocellular carcinoma
- •Cirrhosis with a Child-Pugh score > 8
- •Contra-indication for percutaneous treatment according to Barcelona Clinic Liver Cancer (BCLC) criteria
- •Patients without national health insurance cover
研究组 & 干预措施
RFA
干预措施: Percutaneous Radiofrequency Ablation (Other)
MCT
干预措施: Percutaneous Microwave Ablation (Other)
结局指标
主要结局
Time to disease progression according to American Society of Interventional Radiology criteria
时间窗: Through study completion up to 5 years
次要结局
未报告次要终点