No-touch Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma Using Triple Cooled-Wet Electrodes

Seoul National University Hospital73 enrolled

Overview

To evaluate local tumor progression rate at 12 months after no-touch percutaneous radiofrequency ablation using combined energy delivery mode and triple cooled electrodes

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent Hepatocellular Cancer Chronic Liver Disease and Cirrhosis

Interventions

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

Radiofrequency ablation will be performed by using triple cooled-wet electrodes. Two or three electrodes will be places around 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 of three 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.

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

RECRUITING

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

Disease-free survival

Evaluate disease-free survival by available clinical information and follow-up computed tomography or magnetic resonance imaging with alpha-fetoprotein level

Time frame: 12 moths after radiofrequency ablation

Technical success rate

Evaluate technical success defined as complete ablation of the index tumor with safety margin, equal or larger than 3 mm on 1 month follow-up CT.

Time frame: 1 month after radiofrequency ablation

Overall survival

Evaluate overall survival by available clinical information and follow-up

Time frame: 12 moths after radiofrequency ablation

Complication rate

Evaluate the presence of major or minor radiofrequency ablation related complications on follow-up computed tomography or magnetic resonance imaging.

Time frame: 1, 3, 6, 9, 12 months after radiofrequency ablation.