NCT02745483

Brief Summary

The purpose of this study is to compare the therapeutic outcomes and safety of the study patients who received radiofrequency ablation (RFA) using separable clustered electrodes with those of a matched historical control group who had received RFA using multiple internally-cooled electrodes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Nov 2011

Typical duration for phase_2 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

November 1, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

3.7 years

First QC Date

April 5, 2016

Last Update Submit

April 16, 2016

Conditions

Hepatocellular Carcinoma

Keywords

RFA

Outcome Measures

Primary Outcomes (3)

  • Cumulative 1-year local tumor progression (LTP) rate

    Comparison of rates of LTP in two groups in a year after RFA

    12 months after RFA

  • Cumulative 2-year LTP rate

    Comparison of rates of LTP in two groups in two years after RFA

    24 months after RFA

  • Cumulative 3-year LTP rate

    Comparison of rates of LTP in two groups in three years after RFA

    36 months after RFA

Secondary Outcomes (3)

  • 1-year Recurrence free survival rate

    12 months after RFA

  • 2-year Recurrence free survival rate

    24 months after RFA

  • 3-year Recurrence free survival rate

    36 months after RFA

Other Outcomes (2)

  • Major complication rate after RFA

    30 days after RFA

  • Technical success rate

    1 day after RFA

Study Arms (2)

Separable clustered electrodes

EXPERIMENTAL

Enrolled patients in the prospective study (RFA using separable clustered electrodes (Octopus®)) for treatment-naive HCC (n=79)

Device: Separable clustered electrodes

Historical control group

NO INTERVENTION

Patients who received RFA according to routine protocol in our center (multiple internally-cooled electrodes) for treatment-naive HCC from Jan 2011 to July 2013 in our institution (n=74) .

Interventions

Separable clustered electrodesDEVICE

patients who signed informed consent, RFA was performed using separable clustered electrodes (Octopus®) in which, inter-tine distances can be flexibly adjusted by an operator.

Also known as: Octopus®
Separable clustered electrodes

Eligibility Criteria

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

You may qualify if:

  • HCC diagnosed on biopsy OR typical imaging features of HCC on CT or MRI according to AASLD guidelines
  • HCCs equal to or smaller than 5cm in the liver
  • no direct contact with or invasion into the hepatic hilar structures or inferior vena cava
  • treatment-naive HCC

You may not qualify if:

  • patients with uncontrolled coagulopathy
  • patients with Child-Pugh classification C
  • patients with tumor invasion into the portal vein or hepatic vein
  • extrahepatic spread

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, Suh KS, Yoon JH, Kim YJ, Lee JH, Yu SJ, Han JK. Switching Monopolar Radiofrequency Ablation Using a Separable Cluster Electrode in Patients with Hepatocellular Carcinoma: A Prospective Study. PLoS One. 2016 Aug 30;11(8):e0161980. doi: 10.1371/journal.pone.0161980. eCollection 2016.

    PMID: 27575787DERIVED

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
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 20, 2016

Study Start

November 1, 2011

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

April 20, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)