Hepatocellular Carcinoma
Conditions
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
Interventions
DEVICEMicrowave ablation
Microwave ablation will be performed by using single antenna (Emprint, Medtronic) with overlapping ablation or two antennas (Starwave, STARmed) with simultaneous ablation.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Technical Success | Immediately after ablation | 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. |
| Number of Participants with Technique Efficacy at 1 Month | 1 month after ablation | 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. |
Countries
South Korea
Outcome results
None listed