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

NCT06086002 | Completed

• 1 other identifier: 2308-023-1457
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 month after ablation

Study Arms (2)

Overlapping ablation with single antenna

ACTIVE COMPARATOR

Device: Microwave ablation

Simultaneous ablation with two antennas

EXPERIMENTAL

Device: Microwave ablation

Interventions

Microwave ablation DEVICE

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

Overlapping ablation with single antenna; Simultaneous ablation with two antennas

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: September 18, 2023
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 13, 2026

Record last verified: 2025-09

Locations

KR (1)