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

Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Locoregional Treatment Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes: A Prospective Observational Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatocellular Carcinoma; Local Recurrence of Malignant Tumor of Liver
• Intervention / Treatment: Procedure: Radiofrequency ablation using combined bipolar and monopolar energy deliver with Twin Cooled-Wet electrodes

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Procedure: Radiofrequency ablation using combined bipolar and monopolar energy deliver with Twin Cooled-Wet electrodes; Radiofrequency ablation will be performed by using twin cooled-wet electrodes. Two electrodes will be places on 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 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. The RF energy will be delivered by using the 200 watts single generator.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: RF medical

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Digestive System Neoplasms; Liver Diseases; Carcinoma; Carcinoma, Hepatocellular; Recurrence; Liver Neoplasms
• Other Study ID Numbers: 1907-157-1050

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No