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

Seoul National University Hospital20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

Microwave ablationDEVICE

Microwave ablation will be performed by using single antenna (Emprint, Medtronic) with overlapping ablation or two antennas (Starwave, STARmed) with simultaneous ablation.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Number of Participants with Technical Success

Technical success is defined as complete ablation of the index tumor with a safety margin equal to or greater than 5 mm, as confirmed on the computed tomography (CT) scan performed immediately after the ablation procedure.

Time frame: Immediately after ablation

Number of Participants with Technique Efficacy at 1 Month

Technique efficacy is defined as the absence of residual or recurrent tumor at the ablation site (indicating complete ablation), as confirmed on the 1-month follow-up computed tomography (CT) scan.

Time frame: 1 month after ablation

Data from ClinicalTrials.gov

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