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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05449860
• Other study ID #: 1907-157-1050
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 28, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Neoplasms
• Neoplasms
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	RF medical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety margin evaluation	Evaluate the safety margin around the index tumor on immediate computed tomography (CT)	Immediately after radiofrequency ablation
Secondary	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