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

Not Applicable

Recruiting

• Conditions: Chronic Liver Disease and Cirrhosis; Recurrent Hepatocellular Cancer
• Interventions: Procedure: Radiofrequency ablation using combined bipolar and monopolar energy deliver with Triple Cooled-Wet electrodes

• Registration Number: NCT05449873
• Lead Sponsor: Seoul National University Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-18
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-04
• Study First Posted: 2022-07-08
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-13
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with recurrent hepatocellular carcinoma after locoregional treatment	Radiofrequency ablation using combined bipolar and monopolar energy deliver with Triple Cooled-Wet electrodes	Patients with chronic liver disease have recurrent hepatocellular carcinoma 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	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
Technical success rate	1 month after radiofrequency ablation	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.
Disease-free survival	12 moths after radiofrequency ablation	Evaluate disease-free survival by available clinical information and follow-up computed tomography or magnetic resonance imaging with alpha-fetoprotein level
Complication rate	1, 3, 6, 9, 12 months after radiofrequency ablation.	Evaluate the presence of major or minor radiofrequency ablation related complications on follow-up computed tomography or magnetic resonance imaging.
Overall survival	12 moths after radiofrequency ablation	Evaluate overall survival by available clinical information and follow-up

Trial Locations

Locations (1)

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