Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Device: DSM
* Device: SSM
* Device: Separable clustered electrodes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 %)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RFA with DSM mode<br>RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit. | Device: DSM<br>* Monopolar RFA using dual switching mode (DSM)<br>Device: Separable clustered electrodes<br>* A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.<br>* Other names: Octopus®;|
| Active Comparator: RFA with SSM mode<br>RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit. | Device: SSM<br>* Monopolar RFA using single switching mode (SSM)<br>Device: Separable clustered electrodes<br>* A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.<br>* Other names: Octopus®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum diameter of ablative zone | Minimum diameter of ablative zone on post-RFA CT or MRI in a mm. | 7 days after RFA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor) | 1 month | 
| IDR rate | Cumulative intrahepatic distant recurrence (IDR) rate over two years after RFA | 24 months after RFA | 
| EM rate | Cumulative extrahepatic metastasis (EM) rate over two years after RFA | 24 months after RFA | 
| 1-year local tumor progression (LTP) | Comparison of rates of LTP in two groups in a year after RFA | 12 months after RFA | 
| 2-year LTP | Comparison of rates of LTP in two groups in two years after RFA | 24 months after RFA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RFA