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

Chronic Liver Disease and Cirrhosis Clinical Trial

Official title:

No-touch Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Locoregional Treatment Using Combined Energy Delivery Mode and Triple Cooled-Wet Electrodes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449873
• Other study ID #: 2107-087-1235
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: October 2022
• Source: Seoul National University Hospital
• Contact: Hyun Hee Lee
• Phone: 82-2-2072-4177
• Email: redlion55[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• 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, Hepatocellular
• Chronic Liver Disease and Cirrhosis
• Liver Diseases
• Liver Neoplasms
• Recurrence

Intervention

Procedure:
• Radiofrequency ablation using combined bipolar and monopolar energy deliver with Triple Cooled-Wet electrodes
Radiofrequency ablation will be performed by using triple cooled-wet electrodes. Two or three electrodes will be places around 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 of three 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.

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	Disease-free survival	Evaluate disease-free survival by available clinical information and follow-up computed tomography or magnetic resonance imaging with alpha-fetoprotein level	12 moths after radiofrequency ablation
Secondary	Technical success rate	Evaluate technical success defined as complete ablation of the index tumor with safety margin, equal or larger than 3 mm on 1 month follow-up CT.	1 month after radiofrequency ablation
Secondary	Overall survival	Evaluate overall survival by available clinical information and follow-up	12 moths after radiofrequency ablation
Secondary	Complication rate	Evaluate the presence of major or minor radiofrequency ablation related complications on follow-up computed tomography or magnetic resonance imaging.	1, 3, 6, 9, 12 months after radiofrequency ablation.