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Radiofrequency Ablation With Gradual Radiofrequency Energy Increment for Hepatocellular Carcinoma Treatment

Primary Purpose

Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Liver Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Radiofrequency ablation, Gradual radiofrequency energy increment, Cone-unit ablation

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 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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with clinically diagnosed hepatocellular carcinoma (HCC) (equal or less than 4 cm )

Arm Description

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).

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

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.

Full Information

First Posted
May 26, 2022
Last Updated
June 11, 2022
Sponsor
Seoul National University Hospital
Collaborators
starmed
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1. Study Identification

Unique Protocol Identification Number
NCT05397860
Brief Title
Radiofrequency Ablation With Gradual Radiofrequency Energy Increment for Hepatocellular Carcinoma Treatment
Official Title
Radiofrequency Ablation for Hepatocellular Carcinoma Using Gradual Radiofrequency (RF) Energy Delivery Mode With Octopus Electrodes: A Prospective Observational Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
starmed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Liver Disease
Keywords
Radiofrequency ablation, Gradual radiofrequency energy increment, Cone-unit ablation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Patients with clinically diagnosed hepatocellular carcinoma (HCC) (equal or less than 4 cm )
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes
Intervention Description
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.
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 (RFA)
Secondary Outcome Measure Information:
Title
Success rate of cone-unit ablation
Description
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.
Time Frame
Immediately after radiofrequency ablation (RFA)

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 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
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, M.D.
Phone
82-2-2072-2519
Email
yyssaa21@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
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, RN
Phone
82-2-2072-4177
Email
redlion55@naver.com
First Name & Middle Initial & Last Name & Degree
Jae Hyun Kim, MD
Phone
82-2-2072-2519
Email
yyssaa21@gmail.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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Radiofrequency Ablation With Gradual Radiofrequency Energy Increment for Hepatocellular Carcinoma Treatment

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