Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical feasibility and short-term outcome of switching monopolar RFA using a separable cluster electrode in patients with primary and secondary liver malignancies.

Detailed Description
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Radiofrequency ablation (RFA) is one of minimal invasive treatment methods and it has been showing comparable overall survival with surgery in early or small hepatocellular carcinomas (HCCs) and better cost-effectiveness. However, it is suffering from high local tumor progression (LTP) rate. To reduce LTP rate, creation of large ablative zone has been attempted in various strategies. A separable cluster electrode is a new type of RFA electrode. It consists of three individual applicators and the applicators can be incorporated as a single handle such as a cluster electrode, and can be separated as three electrodes, depending on operators' needs. It allows high flexibility to operators and the preclinical results were promising. Herein, we want to evaluate the clinical feasibility of the electrodes by observing major complication rates, technical success rate and 12-months LTP rate.

Official Title
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Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies

Conditions
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Hepatocellular Carcinoma, Metastasis, Cholangiocarcinoma

Intervention / Treatment
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* Device: Separable cluster electrode (Octopus®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hepatic malignancies diagnosed on biopsy OR Typical imaging features of hepatocellular carcinoma (HCC) on computed tomography (CT) or magnetic resonance imaging (MRI) according to AASLD guideline Typical imaging feature of metastasis on CT or MRI AND 1 5 tumors equal to or smaller than 5cm in the liver no direct contact with or invasion into the hepatic hilar structures or inferior vena cava (IVC) Eastern Cooperative Oncology Group performance status of 0 Patients who signed informed consent Exclusion Criteria: Patients with any of followings are excluded. Patients with uncontrolled coagulopathy Patients with Child-Pugh classification C Patients with tumor invasion in major portal vein or hepatic vein branch Extrahepatic metastasis

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Separable cluster electrode<br>radiofrequency ablation (RFA) using separable cluster electrode in switching monopolar mode. | Device: Separable cluster electrode (Octopus®)<br>* Patients undergo RFA under ultrasound guidance, and separable cluster electrodes are used for RFA in monopolar switching mode, using multiple overlapping technique to create larger ablative zones.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major complication rate after Radiofrequency ablation (RFA) | Rates of major complication according to Society of Interventional Radiology (SIR) grading system, which refers to an event that leads to substantial morbidity and disability (SIR classification C-E). | 30 days after RFA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Technical success addresses that the tumor was treated according to protocol and completely covered by ablative zone on pre-RFA image and post-RFA image side-by-side comparison. | 1 day after RFA | 
| Local control rate | Rate of local tumor progression after RFA | 12 months after RFA | 

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