Anatomical Radiofrequency Ablation for Small Hepatocellular Carcinoma

Seoul National University

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05580224

2208-187-1355

Details and patient eligibility

About

The aim of this study is to investigate therapeutic outcomes of anatomical radiofrequency ablation for peripherally located small hepatocellular carcinoma using combined energy delivery mode and triple cooled-wet electrodes.

Enrollment: 87 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Child-Pugh class A or B7.
• Presence of chronic hepatitis B or liver cirrhosis.
• Patients with hepatocellular carcinomas diagnosed by histopathology or noninvasive imaging-based diagnosis according to the Korean Liver Cancer Association-National Cancer Center Korea guidelines.
• Patients with viable hepatocellular carcinoma after locoregional treatment diagnosed by the Liver Imaging Reporting and Data System.
• Tumor location is less than 5 cm from liver capsule.

Exclusion criteria

• The number of tumor is three or more.
• Tumor size is over 3 cm.
• Tumor location is over 5 cm from liver capsule.
• Child-Pugh class B8-9 or C.
• Presence of macrovascular invasion and/or distant metastasis.
• Platelet count < 50,000 mm3, or international normalized ratio > 1.5 (prothrombin time >1.5 × normal).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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87 participants in 1 patient group

Patients with hepatocellular carcinoma (equal or less than 3 cm)

Experimental group

Description:

Under the guidance of multimodality-ultrasound (US) fusion image, one of the three electrodes was placed across the portal vein branch near the tumor, and the other two electrodes were placed around the tumor through the previously planned approach path. After placement of electrodes, the temperature is maintained at 90-100 degrees Celsius for about 6-30 minutes depending on the size of the tumor, using the combined energy transfer mode that sequentially adds the bipolar mode and/or the monopolar mode.

Treatment:

Procedure: Radiofrequency ablation