Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®)

Study Overview
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Brief Summary
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Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA). A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study. Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group.

Detailed Description
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Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA). A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study. Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group using propensity score matching.

Official Title
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Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®) for Treatment of Focal Liver Malignancies: A Preliminary Study

Conditions
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HCC, Metastasis

Intervention / Treatment
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* Device: DSM
* Device: separable clustered electrode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hepatocellular carcinoma (according to AASLD guideline or LI-RADS) histologically confirmed HCC histologically confirmed or typical imaging feature of colorectal cancer liver metastasis in patients with colorectal cancer AND equal to or larger than 2cm, equal to or smaller than 5cm available cross-sectional liver imaging within 30 days before RFA signed informed consent Exclusion Criteria: history of local treatment on the index tumor more than three tumors in a patient tumors in central portion of portal vein or hepatic vein Child-Pugh class C vascular invasion by tumors uncorrected coagulopathy presence of multiple extrahepatic metastases

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RFA DSM<br>Eligible patients who undergo RFA using DSM and separable clustered electrodes. | Device: DSM<br>* Monopolar RFA using dual switching mode (DSM)<br>Device: separable clustered electrode<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(R);|
| No Intervention: RFA SSM<br>Historical control group consisted of patients underwent RFA in our institution with single switching mode (SSM) and single/ or multiple clustered electrodes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local tumor progression (LTP) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success on 1 months follow-up imaging after RFA (no residual/progressed tumor) |  | 1 months | 
| rate of intrahepatic distant recurrence (IDR) after RFA |  | 12 months | 
| rate of extrahepatic metastasis (EM) after RFA |  | 12 months | 

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