Radiofrequency Ablation With Gradual Radiofrequency Energy Increment for Hepatocellular Carcinoma Treatment

Seoul National University

Status: Enrolling

Conditions: Chronic Liver Disease; Liver Cirrhosis; Hepatocellular Carcinoma

Treatments: Procedure: Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05397860

1909-086-1064

Details and patient eligibility

About

To evaluate local tumor progression rate at 12 months after percutaneous radiofrequency ablation with gradual radiofrequency energy delivery mode with Octopus electrodes in patients with hepatocellular carcinoma.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Child-Pugh Class A or B
• chronic hepatitis B or liver cirrhosis
• contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) within 60 days of scheduled radiofrequency ablation (RFA) date
• clinically diagnosed hepatocellular carcinoma (HCC), equal or less than 4 cm

Exclusion criteria

• number of HCC, equal or more than 3
• largest tumor size over 4 cm
• Child-Pugh class C
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Patients with clinically diagnosed hepatocellular carcinoma (HCC) (equal or less than 4 cm )

Experimental group

Description:

Patients with chronic hepatitis B or liver cirrhosis have hepatocellular carcinoma (HCC) (equal or less than 4 cm) which is diagnosed on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI).

Treatment:

Procedure: Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes