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

Not Applicable

• Conditions: Local Recurrence of Malignant Tumor of Liver; Hepatocellular Carcinoma
• Interventions: Procedure: Radiofrequency ablation using combined bipolar and monopolar energy deliver with Twin Cooled-Wet electrodes

• Registration Number: NCT05449860
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-28
• Status Verified: 2022-07
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-04
• Last Update Submitted: 2022-07-04
• Study First Posted: 2022-07-08
• Last Update Posted: 2022-07-08
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with recurrent hepatocellular carcinoma after locoregional treatment	Radiofrequency ablation using combined bipolar and monopolar energy deliver with Twin Cooled-Wet electrodes	Patients with chronic liver disease have recurrent hepatocellular carcinoma which is diagnosed on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI).

Primary Outcome Measures

Name	Time	Method
Local tumor progression rate	12 months after radiofrequency ablation	Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI) with alpha-fetoprotein (AFP) level

Secondary Outcome Measures

Name	Time	Method
Technical success rate	1 month after radiofrequency ablation	Evaluate technical success defined as complete ablation of the index tumor on 1 month follow-up computed tomography.
Safety margin evaluation	Immediately after radiofrequency ablation	Evaluate the safety margin around the index tumor on immediate computed tomography (CT)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of