The Clinical Value of Percutaneous Radiofrequency Ablation of Feeding Arterial for Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- completed tumor necrosis
研究概览
简要总结
To evaluate a novel technique-ultrasound guided percutaneous abaltion of tumor feeding artery before RFA for liver malignancy.
详细描述
Hepatocellular carcinoma is one of the most common tumor in clinical practice. In recent years, various local therapies, especially radiofrequency ablation (RFA) has been proved safe and effective.The main limitation of RFA is that its therapeutic impact is significant compromised by blood flow cooling effect, especially in hypervascular HCC. Recent studies showed combined therapy of TACE and RFA can decrease the blood supply of tumor, increase ablated volume and therefore improve the outcome. However, TACE application is limited in patients who cannot tolerate this therapy due to the side effects of repeated TACE, poor liver function or previously legated hepatic artery. The present study is focus on "difficult-to-treat" HCC patients who are neither surgical candidates, nor TACE candidates. The investigators introduce the novel treatment mode that RFA followed ultrasound guided percutaneous ablation of tumur feeding arterial to treat these difficult cases and evaluate the clinical effect.
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
- Single (Participant)
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
- •tumor number ≤3， maximum tumor size ≤5cm;
- •accessibility of tumors via a percutaneous approach;
- •tumor feeding artery can be detected by 3D contrast enhance ultrasound;
- •platelet count ≥ 50,000/ml and INR <1.6;
- •life expectancy more than 6 months
- •Child grade A or B
排除标准
- •patients who scheduled liver transplantation
- •with extrahepatic metastasis
- •women during menstruation, pregnancy, child birth and baby nursing period
- •patients with severe mental disorder
- •cardiopulmonary failure
研究组 & 干预措施
PAFA and tumor ablation
first percutaneous frequency ablation of tumor feeding artery and then ablation of tumor
干预措施: PAFA (Other)
PAFA and tumor ablation
first percutaneous frequency ablation of tumor feeding artery and then ablation of tumor
干预措施: tumor ablation (Other)
tumor ablation
ablation of tumor directly
干预措施: tumor ablation (Other)
结局指标
主要结局
completed tumor necrosis
时间窗: 1 month
Contrast enhanced CT or MRI was examed to evaluate tumor necrosis 1 month after ablation.
次要结局
- tumor recurrence(up to 36 months)
研究者
Kun Yan
Director of ultrasonography department
Peking University Cancer Hospital & Institute