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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06086002

Collaborator

(none)

Enrollment

Location

Arms

14.5

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Device: Microwave ablation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 18, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Overlapping ablation with single antenna

Device: Microwave ablation

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

Experimental: Simultaneous ablation with two antennas

Device: Microwave ablation

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeong Min Lee, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT06086002

Other Study ID Numbers:

2308-023-1457

First Posted:

Oct 17, 2023

Last Update Posted:

Oct 17, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Oct 17, 2023