Comparison of Immunological Response After Microwave Ablation and Irreversible Electroporation of Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Immunological response
研究概览
简要总结
Local ablative treatment of Hepatocellular Carcinoma is performed primary on patients not eligible for liver transplant or liver resection. At our Hospital two different methods are used: Microwave ablation, where the tumor cells are heated up and killed, and Irreversible electroporation, where the tumor cells are exposed to an electrical field and nano-pores are formed in the cell membranes and the cells go into apoptosis (programed cell death).
Previous studies have shown effects on the immune system after ablative therapies.
The purpose of this study is to compare the immunological response after the wo different methods of killing the tumor cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Hepatocellular carcinoma, maximum 3 lesions, maximum 30 mm in any cross section diameter
- •Physically fit to undergo general anaesthesia
- •Fully understand swedish instructions regarding the study
排除标准
- •Atrial fibrillation (for irreversible electroporation)
- •Pacemaker (for irreversible electroporation)
- •>3 lesions
- •> 30 mm in any cross section diameter
结局指标
主要结局
Immunological response
时间窗: Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90
Change in immunological response
次要结局
- Number of participants with complete radiological response at follow up 3, 6, 9 and 12 months.(Follow-up every three months for one year with CT scan.)