Back to resultsRadiofrequency Ablation for Recurrent Hepatocellular Carcinoma With Twin Cooled-wet Electrodes
Primary Purpose
Hepatocellular Carcinoma, Local Recurrence of Malignant Tumor of Liver
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Radiofrequency ablation using combined bipolar and monopolar energy deliver with Twin Cooled-Wet electrodes
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with recurrent hepatocellular carcinoma after locoregional treatment
Arm Description
Patients with chronic liver disease have recurrent hepatocellular carcinoma which is diagnosed on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI).
Outcomes
Primary Outcome Measures
Local tumor progression rate
Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI) with alpha-fetoprotein (AFP) level
Secondary Outcome Measures
Safety margin evaluation
Evaluate the safety margin around the index tumor on immediate computed tomography (CT)
Technical success rate
Evaluate technical success defined as complete ablation of the index tumor on 1 month follow-up computed tomography.
Full Information
NCT ID
NCT05449860
First Posted
July 4, 2022
Last Updated
July 4, 2022
Sponsor
Seoul National University Hospital
Collaborators
RF medical
1. Study Identification
Unique Protocol Identification Number
NCT05449860
Brief Title
Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma With Twin Cooled-wet Electrodes
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 28, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
RF medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Local Recurrence of Malignant Tumor of Liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with recurrent hepatocellular carcinoma after locoregional treatment
Arm Type
Experimental
Arm Description
Patients with chronic liver disease have recurrent hepatocellular carcinoma which is diagnosed on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI).
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation using combined bipolar and monopolar energy deliver with Twin Cooled-Wet electrodes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Local tumor progression rate
Description
Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI) with alpha-fetoprotein (AFP) level
Time Frame
12 months after radiofrequency ablation
Secondary Outcome Measure Information:
Title
Safety margin evaluation
Description
Evaluate the safety margin around the index tumor on immediate computed tomography (CT)
Time Frame
Immediately after radiofrequency ablation
Title
Technical success rate
Description
Evaluate technical success defined as complete ablation of the index tumor on 1 month follow-up computed tomography.
Time Frame
1 month after radiofrequency ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma With Twin Cooled-wet Electrodes
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