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

Seoul National University

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Device: Microwave ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06086002

2308-023-1457

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Overlapping ablation with single antenna

Active Comparator group

Treatment:

Device: Microwave ablation

Simultaneous ablation with two antennas

Experimental group

Treatment:

Device: Microwave ablation