NCT03699657

Brief Summary

This study was conducted to prospectively compare the efficacy, safety and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) with those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Dec 2014

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

December 15, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2019

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

3.3 years

First QC Date

October 5, 2018

Last Update Submit

March 18, 2020

Conditions

Hepatocellular Carcinoma

Keywords

RFA

Outcome Measures

Primary Outcomes (1)

  • Minimum diameter of ablative zone

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

    7 days after RFA

Secondary Outcomes (5)

  • Technical success rate

    1 month

  • IDR rate

    24 months after RFA

  • EM rate

    24 months after RFA

  • 1-year local tumor progression (LTP)

    12 months after RFA

  • 2-year LTP

    24 months after RFA

Other Outcomes (4)

  • Complication

    1 month after RFA

  • Volume of ablative zone

    7 days after RFA

  • Ablation time

    1 day

  • +1 more other outcomes

Study Arms (2)

RFA with DSM mode

ACTIVE COMPARATOR

RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.

Device: DSMDevice: Separable clustered electrodes

RFA with SSM mode

ACTIVE COMPARATOR

RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.

Device: SSMDevice: Separable clustered electrodes

Interventions

DSMDEVICE

Monopolar RFA using dual switching mode (DSM)

RFA with DSM mode
SSMDEVICE

Monopolar RFA using single switching mode (SSM)

RFA with SSM mode
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®
RFA with DSM modeRFA with SSM mode

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with HCC (\>= 1.5cm and \< 5cm in maximal diameter) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
  • no history of previous locoregional treatment

You may not qualify if:

  • more than three HCC nodules
  • tumors abutting to the central portal vein or hepatic vein with a diameter \> 5 mm
  • Child-Pugh class C
  • tumors with major vascular invasion
  • extrahepatic metastasis
  • severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or 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

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

October 5, 2018

First Posted

October 9, 2018

Study Start

December 15, 2014

Primary Completion

April 11, 2018

Study Completion

June 19, 2019

Last Updated

March 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)