Radiofrequency Ablation With Gradual Radiofrequency Energy Increment for Hepatocellular Carcinoma Treatment

Hepatocellular Carcinoma Clinical Trial

Official title:

Radiofrequency Ablation for Hepatocellular Carcinoma Using Gradual Radiofrequency (RF) Energy Delivery Mode With Octopus Electrodes: A Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397860
• Other study ID #: 1909-086-1064
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: August 30, 2023

Study information

• Verified date: June 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 percutaneous radiofrequency ablation with gradual radiofrequency energy delivery mode with Octopus electrodes in patients with hepatocellular carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 30, 2023
• Est. primary completion date: August 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 liver cirrhosis

• contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) within 60 days of scheduled radiofrequency ablation (RFA) date

• clinically diagnosed hepatocellular carcinoma (HCC), equal or less than 4 cm

Exclusion Criteria:

• number of HCC, equal or more than 3

• largest tumor size over 4 cm

• Child-Pugh class C

• 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
• Chronic Liver Disease
• Hepatocellular Carcinoma
• Liver Cirrhosis
• Liver Diseases

Intervention

Procedure:
• Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes
Radiofrequency ablation (RFA) will be performed by using multi-VIVA generator and Octopus electrodes. Three electrodes will be placed 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) 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. The RF energy will starts at 60 watts and increase by 10 watts every 30 seconds for the first 3 minutes, and then increases gradually by 10 watts per minute after reaching 100 watts.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	starmed

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 (RFA)
Secondary	Success rate of cone-unit ablation	The cone-unit ablation is defined as complete ablation of tumor with safety margin and occlusion of the 4th or 5th branches of portal vein.	Immediately after radiofrequency ablation (RFA)