Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma With Twin Cooled-wet Electrodes

Seoul National University Hospital102 enrolled

Overview

To investigate the therapeutic effects and treatment results of radiofrequency ablation using combined bipolar and monopolar energy deliver with twin cooled-wet electrodes for recurrent tumor after locoregional treatment in patients with hepatocellular carcinoma.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Hepatocellular Carcinoma Local Recurrence of Malignant Tumor of Liver

Interventions

Radiofrequency ablation using combined bipolar and monopolar energy deliver with Twin Cooled-Wet electrodesPROCEDURE

Radiofrequency ablation will be performed by using twin cooled-wet electrodes. Two electrodes will be places on the tumor under ultrasonography (US)-computed tomography (CT)/magnetic resonance (MR) fusion tool guidance. The electrodes will be cooled with saline, and radiofrequency (RF, bipolar mode and switching monopolar mode) will be applied to two electrodes at the same time for about 6 to 30 minutes depending on the tumor size. The temperature will be maintained at 90-100 °C. The RF energy will be delivered by using the 200 watts single generator.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Child-Pugh Class A or B * chronic hepatitis B or chronic hepatitis C or liver cirrhosis * presence of recurrent hepatocellular carcinoma (HCC) after locoregional treatment 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 5 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 * platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50% * presence of extrahepatic metastasis

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Local tumor progression rate

Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI) with alpha-fetoprotein (AFP) level

Time frame: 12 months after radiofrequency ablation

Secondary Outcomes

Safety margin evaluation

Evaluate the safety margin around the index tumor on immediate computed tomography (CT)

Time frame: Immediately after radiofrequency ablation

Technical success rate

Evaluate technical success defined as complete ablation of the index tumor on 1 month follow-up computed tomography.

Time frame: 1 month after radiofrequency ablation

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.