Back to resultsAnatomical Radiofrequency Ablation for Small Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Radiofrequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Child-Pugh class A or B7.
- Presence of chronic hepatitis B or liver cirrhosis.
- Patients with hepatocellular carcinomas diagnosed by histopathology or noninvasive imaging-based diagnosis according to the Korean Liver Cancer Association-National Cancer Center Korea guidelines.
- Patients with viable hepatocellular carcinoma after locoregional treatment diagnosed by the Liver Imaging Reporting and Data System.
- Tumor location is less than 5 cm from liver capsule.
Exclusion Criteria:
- The number of tumor is three or more.
- Tumor size is over 3 cm.
- Tumor location is over 5 cm from liver capsule.
- Child-Pugh class B8-9 or C.
- Presence of macrovascular invasion and/or distant metastasis.
- Platelet count < 50,000 mm3, or international normalized ratio > 1.5 (prothrombin time >1.5 × normal).
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with hepatocellular carcinoma (equal or less than 3 cm)
Arm Description
Under the guidance of multimodality-ultrasound (US) fusion image, one of the three electrodes was placed across the portal vein branch near the tumor, and the other two electrodes were placed around the tumor through the previously planned approach path. After placement of electrodes, the temperature is maintained at 90-100 degrees Celsius for about 6-30 minutes depending on the size of the tumor, using the combined energy transfer mode that sequentially adds the bipolar mode and/or the monopolar mode.
Outcomes
Primary Outcome Measures
Technical success
Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.
Local tumor progression rate
Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success.
Secondary Outcome Measures
Complication after radiofrequency ablation
Post-radiofrequency ablation complications were defined as problems noted within 1 month after RFA as well as additional complications identified on follow-up imaging and judged to be likely caused by radiofrequency ablation.
Recurrence-free survival
Recurrence-free survival was defined as the interval between radiofrequency ablation and the date of any type of recurrence or the last follow-up date if there was no recurrence.
Full Information
NCT ID
NCT05580224
First Posted
October 11, 2022
Last Updated
October 11, 2022
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05580224
Brief Title
Anatomical Radiofrequency Ablation for Small Hepatocellular Carcinoma
Official Title
Anatomical Radiofrequency Ablation for Peripherally Located Small Hepatocellular Carcinoma 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 4, 2022 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
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
The aim of this study is to investigate therapeutic outcomes of anatomical radiofrequency ablation for peripherally located small hepatocellular carcinoma using combined energy delivery mode and triple cooled-wet electrodes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with hepatocellular carcinoma (equal or less than 3 cm)
Arm Type
Experimental
Arm Description
Under the guidance of multimodality-ultrasound (US) fusion image, one of the three electrodes was placed across the portal vein branch near the tumor, and the other two electrodes were placed around the tumor through the previously planned approach path. After placement of electrodes, the temperature is maintained at 90-100 degrees Celsius for about 6-30 minutes depending on the size of the tumor, using the combined energy transfer mode that sequentially adds the bipolar mode and/or the monopolar mode.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Intervention Description
Radiofrequency ablation is performed for peripherally located small hepatocellular carcinoma using combined energy delivery mode and triple cooled-wet electrodes. One of three electrodes is placed across the 4th or 5th portal vein branches near the target tumor which enables anatomical ablation of tumor.
Primary Outcome Measure Information:
Title
Technical success
Description
Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.
Time Frame
Immediately after radiofrequency ablation
Title
Local tumor progression rate
Description
Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success.
Time Frame
12 months after radiofrequency ablation
Secondary Outcome Measure Information:
Title
Complication after radiofrequency ablation
Description
Post-radiofrequency ablation complications were defined as problems noted within 1 month after RFA as well as additional complications identified on follow-up imaging and judged to be likely caused by radiofrequency ablation.
Time Frame
Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation
Title
Recurrence-free survival
Description
Recurrence-free survival was defined as the interval between radiofrequency ablation and the date of any type of recurrence or the last follow-up date if there was no recurrence.
Time Frame
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 B7.
Presence of chronic hepatitis B or liver cirrhosis.
Patients with hepatocellular carcinomas diagnosed by histopathology or noninvasive imaging-based diagnosis according to the Korean Liver Cancer Association-National Cancer Center Korea guidelines.
Patients with viable hepatocellular carcinoma after locoregional treatment diagnosed by the Liver Imaging Reporting and Data System.
Tumor location is less than 5 cm from liver capsule.
Exclusion Criteria:
The number of tumor is three or more.
Tumor size is over 3 cm.
Tumor location is over 5 cm from liver capsule.
Child-Pugh class B8-9 or C.
Presence of macrovascular invasion and/or distant metastasis.
Platelet count < 50,000 mm3, or international normalized ratio > 1.5 (prothrombin time >1.5 × normal).
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
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
Learn more about this trial
Anatomical Radiofrequency Ablation for Small Hepatocellular Carcinoma
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