Immunological Response After Ablative Therapy in the Liver (IRAL)
Comparison of Immunological Response After Microwave Ablation and Irreversible Electroporation of Hepatocellular Carcinoma
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.
研究概览
研究类型
阶段
- 不适用
联系人和位置
学习地点
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Stockholm、瑞典、18288
- Department of Surgery and Urology, Danderyd Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Atrial fibrillation (for irreversible electroporation)
- Pacemaker (for irreversible electroporation)
- >3 lesions
- > 30 mm in any cross section diameter
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Microwave ablation
20 patients will be treated with microwave ablation
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其他：Irreversible electroporation
20 patients will be treated with irreversible electroporation
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其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Immunological response
大体时间：Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90
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Change in immunological response
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Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants with complete radiological response at follow up 3, 6, 9 and 12 months.
大体时间：Follow-up every three months for one year with CT scan.
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Compare the effect of the two different ablative methods
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Follow-up every three months for one year with CT scan.
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合作者和调查者
调查人员
- 首席研究员：Jacob Freedman, MD, PhD、Karolinska Instituet
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.