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临床试验/NCT02745483
NCT02745483已完成2 期

Prospective, Single-center, Single-arm, Clinical Trial Evaluating the Clinical Efficacy and Safety of a Novel Separable Cluster Electrode in Patients With Focal Liver Malignancies

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
153
试验地点
1
主要终点
Cumulative 3-year LTP rate

研究概览

简要总结

The purpose of this study is to compare the therapeutic outcomes and safety of the study patients who received radiofrequency ablation (RFA) using separable clustered electrodes with those of a matched historical control group who had received RFA using multiple internally-cooled electrodes.

详细描述

Although RFA is widely used as a curative treatment option for a variety of liver malignancies, it is generally limited for treating tumors larger than 2 cm in diameter with a sufficient tumor-free margin. Thus, various strategies are employed to create a sufficient ablation zone such as internally cooled-electrodes, expandable electrodes and adaptation of switching mono/bipolar controllers. Despite that these attempts have created larger ablative zones in clinical and preclinical studies, the efficacy should be validated in terms of clinical outcome.

In this study, investigators evaluated the therapeutic outcomes and safety of RFA using separable clustered electrodes for treatment-naive hepatocellular carcinomas (HCCs) in comparison with RFA using multiple internally-cooled electrodes. The study group is a subgroup of our prospective study cohort (NCT02683538) and a control group is a matched historical group received RFA in our institution using multiple internally-cooled electrodes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Cumulative 3-year LTP rate

时间窗: 36 months after RFA

Comparison of rates of LTP in two groups in three years after RFA

Cumulative 2-year LTP rate

时间窗: 24 months after RFA

Comparison of rates of LTP in two groups in two years after RFA

Cumulative 1-year local tumor progression (LTP) rate

时间窗: 12 months after RFA

Comparison of rates of LTP in two groups in a year after RFA

次要结局

  • 3-year Recurrence free survival rate(36 months after RFA)
  • 2-year Recurrence free survival rate(24 months after RFA)
  • 1-year Recurrence free survival rate(12 months after RFA)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong Min Lee

Professor

Seoul National University Hospital

研究点 (1)

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