NCT05397860

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

3.6 years

First QC Date

May 26, 2022

Last Update Submit

June 11, 2022

Conditions

Hepatocellular CarcinomaLiver CirrhosisChronic Liver Disease

Keywords

Radiofrequency ablationGradual radiofrequency energy incrementCone-unit ablation

Outcome Measures

Primary Outcomes (1)

  • Local tumor progression rate

    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 Outcomes (1)

  • Success rate of cone-unit ablation

    Immediately after radiofrequency ablation (RFA)

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodesPROCEDURE

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.

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

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (2)

  • Hwang S, Kim JH, Yu SJ, Lee JM. Incremental high power radiofrequency ablation with multi-electrodes for small hepatocellular carcinoma: a prospective study. BMC Gastroenterol. 2024 Aug 21;24(1):280. doi: 10.1186/s12876-024-03358-w.

    PMID: 39169297DERIVED

  • Kim JH, Kim HS, Yoon JH, Joo I, Yoon JH, Kim YJ, Yu SJ, Lee JM. Anatomical ablation for small hepatocellular carcinomas using multiple applicators: a preliminary study. Cancer Imaging. 2023 Aug 21;23(1):78. doi: 10.1186/s40644-023-00597-0.

    PMID: 37605251DERIVED

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Cirrhosis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeong Min Lee, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Hee Lee

CONTACT

82-2-2072-4177redlion55@naver.com

Jae Hyun Kim, M.D.

CONTACT

82-2-2072-2519yyssaa21@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 26, 2022

First Posted

May 31, 2022

Study Start

January 6, 2020

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

June 15, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)