Clinical Feasibility of Microwave Ablation Using Two Channel Microwave Generator and Two Antennas for Small Hepatocellular Carcinoma

Study Overview
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Brief Summary
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To compare safety and efficacy of microwave ablation with simultaneous ablation using two antennas versus overlapping ablation with single antenna for small hepatocellular carcinoma

Official Title
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Evaluation of Clinical Feasibility of Microwave Ablation Using Two Channel Microwave Generator and Two Antennas for Small Hepatocellular Carcinoma: A Preliminary Prospective Single Center Study

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Device: Microwave ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child-Pugh Class A or B chronic hepatitis B or chronic hepatitis C or liver cirrhosis presence of hepatocellular carcinoma (HCC) confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018 single lesion less than or equal to 3 cm, or up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment Exclusion Criteria: number of recurrent HCCs, equal or more than 3 largest recurrent HCC size over 3 cm presence of vascular invasion by HCC diffuse infiltrative type HCC HCCs located less than 5 mm from central bile duct or large portal vein or large hepatic vein platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50% presence of extrahepatic metastasis

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Overlapping ablation with single antenna<br> | Device: Microwave ablation<br>* Microwave ablation will be performed by using single antenna (Emprint, Medtronic) with overlapping ablation or two antennas (Starwave, STARmed) with simultaneous ablation.<br>|
| Experimental: Simultaneous ablation with two antennas<br> | Device: Microwave ablation<br>* Microwave ablation will be performed by using single antenna (Emprint, Medtronic) with overlapping ablation or two antennas (Starwave, STARmed) with simultaneous ablation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Evaluate technical success defined as complete ablation of the index tumor with safety margin, equal or larger than 5 mm on immediate CT. | Immediately after ablation | 
| Technique efficacy | Evaluate technical success defined as complete ablation of the index tumor on 1 month follow-up CT. | 1 month after ablation |