NCT03806218

Brief Summary

This study was conducted to provide preliminary data for the main trial to compare efficacy between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and switching monopolar RFA using separable clustered electrodes in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started May 2015

Typical duration for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

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

May 16, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2019

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

3 years

First QC Date

January 14, 2019

Last Update Submit

April 3, 2020

Conditions

Hepatocellular Carcinoma

Keywords

RFA

Outcome Measures

Primary Outcomes (1)

  • Minimum diameter of ablation zone per unit time

    Minimum diameter of ablative zone per unit time on post-RFA CT or MRI in a mm.

    3 days after RFA

Secondary Outcomes (4)

  • Technique efficacy

    1 month after RFA

  • IDR rate

    12 months, 24 months after RFA

  • EM rate

    12 months, 24 months after RFA

  • Local tumor progression (LTP)

    12 months, 24 months after RFA

Other Outcomes (3)

  • Complication

    1 month after RFA

  • Volume of ablative zone

    3 days after RFA

  • Ablation time

    1 day

Study Arms (2)

TICW-RFA

ACTIVE COMPARATOR

Bipolar RFA using twin internally cooled-wet electrodes

Device: Bipolar RFADevice: Twin internally cooled-wet electrodes

SC-RFA

ACTIVE COMPARATOR

Switching monopolar RFA using separable clustered electrodes

Device: SM-RFADevice: Separable clustered electrodes

Interventions

Bipolar RFADEVICE

Bipolar RFA in which RF currents flow between two electrodes

TICW-RFA
SM-RFADEVICE

Monopolar RFA using multiple electrodes with switching mode

SC-RFA
Twin internally cooled-wet electrodesDEVICE

Saline-enhanced twin internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity

Also known as: CWTN-T
TICW-RFA
Separable clustered electrodesDEVICE

A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.

Also known as: Octopus®
SC-RFA

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • radiologic or pathologic diagnosis of HCC recurrence after locoregional treatment
  • HCC nodules measuring 1 cm or larger and smaller than 5 cm

You may not qualify if:

  • more than three HCC nodules
  • tumors with major vascular invasion or abutment to the central portal or hepatic vein with a diameter \> 5mm
  • extrahepatic metastasis
  • Child-Pugh class C
  • severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or prothrombin time international normalized ratio (PT-INR) prolongation of more than 50 %)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Choi JW, Lee JM, Lee DH, Yoon JH, Kim YJ, Lee JH, Yu SJ, Cho EJ. Radiofrequency ablation using internally cooled wet electrodes in bipolar mode for the treatment of recurrent hepatocellular carcinoma after locoregional treatment: A randomized prospective comparative study. PLoS One. 2020 Sep 28;15(9):e0239733. doi: 10.1371/journal.pone.0239733. eCollection 2020.

    PMID: 32986758DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Jeong Min Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 16, 2019

Study Start

May 16, 2015

Primary Completion

May 16, 2018

Study Completion

February 12, 2019

Last Updated

April 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)