Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies: Follow-up Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Device: Separable clustered electrodes


Participation Criteria
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Eligibility Criteria
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Inclusion criteria HCC diagnosed on biopsy OR typical imaging features of HCC on CT or MRI according to AASLD guidelines 1-3 HCCs equal to or smaller than 5cm in the liver no direct contact with or invasion into the hepatic hilar structures or inferior vena cava treatment-naive HCC Exclusion criteria patients with uncontrolled coagulopathy patients with Child-Pugh classification C patients with tumor invasion into the portal vein or hepatic vein extrahepatic spread

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| Experimental: Separable clustered electrodes<br>Enrolled patients in the prospective study (RFA using separable clustered electrodes (Octopus®)) for treatment-naive HCC (n=79) | Device: Separable clustered electrodes<br>* patients who signed informed consent, RFA was performed using separable clustered electrodes (Octopus®) in which, inter-tine distances can be flexibly adjusted by an operator.<br>* Other names: Octopus®;|
| No Intervention: Historical control group<br>Patients who received RFA according to routine protocol in our center (multiple internally-cooled electrodes) for treatment-naive HCC from Jan 2011 to July 2013 in our institution (n=74) . | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative 1-year local tumor progression (LTP) rate | Comparison of rates of LTP in two groups in a year after RFA | 12 months after RFA | 
| Cumulative 2-year LTP rate | Comparison of rates of LTP in two groups in two years after RFA | 24 months after RFA | 
| Cumulative 3-year LTP rate | Comparison of rates of LTP in two groups in three years after RFA | 36 months after RFA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year Recurrence free survival rate | comparison of survival rate without disease progression in two groups | 12 months after RFA | 
| 2-year Recurrence free survival rate | comparison of survival rate without disease progression in two groups | 24 months after RFA | 
| 3-year Recurrence free survival rate | comparison of survival rate without disease progression in two groups | 36 months after RFA | 

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