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

Seoul National University

Status: Enrolling

Conditions: Chronic Liver Disease and Cirrhosis; Recurrent Hepatocellular Cancer

Treatments: Procedure: Radiofrequency ablation using combined bipolar and monopolar energy deliver with Triple Cooled-Wet electrodes

Study type: Interventional

Funder types: Other

Identifiers

NCT05449873

2107-087-1235

Details and patient eligibility

About

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

Enrollment: 73 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

73 participants in 1 patient group

Patients with recurrent hepatocellular carcinoma after locoregional treatment

Experimental group

Description:

Patients with chronic liver disease have recurrent hepatocellular carcinoma which is diagnosed on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI).

Treatment:

Procedure: Radiofrequency ablation using combined bipolar and monopolar energy deliver with Triple Cooled-Wet electrodes