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临床试验/NCT03699657
NCT03699657已完成不适用

Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2014年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
Minimum diameter of ablative zone

研究概览

简要总结

This study was conducted to prospectively compare the efficacy, safety and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) with those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC).

详细描述

Recently, dual switching monopolar RFA (DSM-RFA) was developed to enhance further the efficiency of the single switching monopolar RFA (SSM-RFA) in creating ablation zone; Yoon et al. reported that DSM-RFA allowed significantly greater RF energy delivery to target tissue per given time, and then, created significantly larger ablation zone than the SSM-RFA in ex vivo and in vivo animal experiments. A retrospective comparative study by Choi et al. reported that the DSM-RFA created significantly larger ablation volume than, but seemed to show similar LTP rate to the SSM-RFA. Still, whether the physical differences between SSM-RFA and DSM-RFA translate into better clinical outcomes remains an open question. Regarding that the choice of equipment is an essential factor to consider in planning image-guided tumor ablation procedure, we thought that the prospective comparison between DSM-RFA and the SSM-RFA would be helpful for improving results of RFA.

Therefore, the purpose of this study was to prospectively compare the efficacy, safety and mid-term outcomes of DSM-RFA with those of conventional SSM-RFA in the treatment of HCC.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed with HCC (>= 1.5cm and < 5cm in maximal diameter) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
  • •no history of previous locoregional treatment

排除标准

  • •more than three HCC nodules
  • •tumors abutting to the central portal vein or hepatic vein with a diameter > 5 mm
  • •Child-Pugh class C
  • •tumors with major vascular invasion
  • •extrahepatic metastasis
  • •severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or INR prolongation of more than 50 %)

研究组 & 干预措施

RFA with DSM mode

Active Comparator

RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.

干预措施: DSM (Device)

RFA with DSM mode

Active Comparator

RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.

干预措施: Separable clustered electrodes (Device)

RFA with SSM mode

Active Comparator

RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.

干预措施: Separable clustered electrodes (Device)

RFA with SSM mode

Active Comparator

RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.

干预措施: SSM (Device)

结局指标

主要结局

Minimum diameter of ablative zone

时间窗: 7 days after RFA

Minimum diameter of ablative zone on post-RFA CT or MRI in a mm.

次要结局

  • 1-year local tumor progression (LTP)(12 months after RFA)
  • Technical success rate(1 month)
  • IDR rate(24 months after RFA)
  • EM rate(24 months after RFA)
  • 2-year LTP(24 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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