Radiofrequency Ablation With Gradual Radiofrequency Energy Increment for Hepatocellular Carcinoma Treatment

Not Applicable

• Conditions: Hepatocellular Carcinoma; Chronic Liver Disease; Liver Cirrhosis
• Interventions: Procedure: Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes

• Registration Number: NCT05397860
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-06
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-05-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-11
• Last Update Posted: 2022-06-15
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with clinically diagnosed hepatocellular carcinoma (HCC) (equal or less than 4 cm )	Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes	Patients with chronic hepatitis B or liver cirrhosis have hepatocellular carcinoma (HCC) (equal or less than 4 cm) 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 (RFA)	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
Success rate of cone-unit ablation	Immediately after radiofrequency ablation (RFA)	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.

Trial Locations

Locations (1)

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