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

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: Microwave ablation

• Registration Number: NCT06086002
• Lead Sponsor: Seoul National University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-18
• Status Verified: 2023-10
• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Last Update Submitted: 2023-10-10
• Study First Posted: 2023-10-17
• Last Update Posted: 2023-10-17
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simultaneous ablation with two antennas	Microwave ablation	-
Overlapping ablation with single antenna	Microwave ablation	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of