Radiofrequency Ablation With Gradual Radiofrequency Energy Increment for Hepatocellular Carcinoma Treatment

June 11, 2022 updated by: Jeong Min Lee, Seoul National University Hospital

Radiofrequency Ablation for Hepatocellular Carcinoma Using Gradual Radiofrequency (RF) Energy Delivery Mode With Octopus Electrodes: A Prospective Observational Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with clinically diagnosed hepatocellular carcinoma (HCC) (equal or less than 4 cm )
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).
Procedure: Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local tumor progression rate
Time Frame: 12 months after radiofrequency ablation (RFA)
Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI) with alpha-fetoprotein (AFP) level
12 months after radiofrequency ablation (RFA)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of cone-unit ablation
Time Frame: Immediately after radiofrequency ablation (RFA)
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.
Immediately after radiofrequency ablation (RFA)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Starmed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 6, 2020

Primary Completion (ANTICIPATED)

August 30, 2023

Study Completion (ANTICIPATED)

August 30, 2023

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (ACTUAL)

May 31, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 11, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1909-086-1064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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