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

Primary Purpose

Recurrent Hepatocellular Cancer, Chronic Liver Disease and Cirrhosis

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Radiofrequency ablation using combined bipolar and monopolar energy deliver with Triple Cooled-Wet electrodes
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Hepatocellular Cancer focused on measuring No-touch radiofrequency ablation, Combined energy delivery mode, Triple cooled-wet electrodes

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 HospitalRecruiting

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

Disease-free survival
Evaluate disease-free survival by available clinical information and follow-up computed tomography or magnetic resonance imaging with alpha-fetoprotein level
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.
Overall survival
Evaluate overall survival by available clinical information and follow-up
Complication rate
Evaluate the presence of major or minor radiofrequency ablation related complications on follow-up computed tomography or magnetic resonance imaging.

Full Information

First Posted
July 4, 2022
Last Updated
October 10, 2022
Sponsor
Seoul National University Hospital
Collaborators
RF medical
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1. Study Identification

Unique Protocol Identification Number
NCT05449873
Brief Title
No-touch Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma Using Triple Cooled-Wet Electrodes
Official Title
No-touch Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Locoregional Treatment Using Combined Energy Delivery Mode and Triple Cooled-Wet Electrodes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (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 evaluate local tumor progression rate at 12 months after no-touch percutaneous radiofrequency ablation using combined energy delivery mode and triple cooled electrodes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Hepatocellular Cancer, Chronic Liver Disease and Cirrhosis
Keywords
No-touch radiofrequency ablation, Combined energy delivery mode, Triple cooled-wet electrodes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Anticipated)

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 Triple Cooled-Wet electrodes
Intervention Description
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.
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
Disease-free survival
Description
Evaluate disease-free survival by available clinical information and follow-up computed tomography or magnetic resonance imaging with alpha-fetoprotein level
Time Frame
12 moths after radiofrequency ablation
Title
Technical success rate
Description
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.
Time Frame
1 month after radiofrequency ablation
Title
Overall survival
Description
Evaluate overall survival by available clinical information and follow-up
Time Frame
12 moths after radiofrequency ablation
Title
Complication rate
Description
Evaluate the presence of major or minor radiofrequency ablation related complications on follow-up computed tomography or magnetic resonance imaging.
Time Frame
1, 3, 6, 9, 12 months 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Hee Lee
Phone
82-2-2072-4177
Email
redlion55@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Hyun Kim
Phone
82-2-2072-2519
Email
yyssaa21@gmail.com
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Hee Lee
Phone
82-2-2072-4177
Email
redlion55@naver.com
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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