Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies: Follow-up Study

April 16, 2016 updated by: Jeong Min Lee, Seoul National University Hospital

Prospective, Single-center, Single-arm, Clinical Trial Evaluating the Clinical Efficacy and Safety of a Novel Separable Cluster Electrode in Patients With Focal Liver Malignancies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although RFA is widely used as a curative treatment option for a variety of liver malignancies, it is generally limited for treating tumors larger than 2 cm in diameter with a sufficient tumor-free margin. Thus, various strategies are employed to create a sufficient ablation zone such as internally cooled-electrodes, expandable electrodes and adaptation of switching mono/bipolar controllers. Despite that these attempts have created larger ablative zones in clinical and preclinical studies, the efficacy should be validated in terms of clinical outcome.

In this study, investigators evaluated the therapeutic outcomes and safety of RFA using separable clustered electrodes for treatment-naive hepatocellular carcinomas (HCCs) in comparison with RFA using multiple internally-cooled electrodes. The study group is a subgroup of our prospective study cohort (NCT02683538) and a control group is a matched historical group received RFA in our institution using multiple internally-cooled electrodes.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 2

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • HCC diagnosed on biopsy OR typical imaging features of HCC on CT or MRI according to AASLD guidelines
  • 1-3 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

Exclusion criteria

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

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Separable clustered electrodes
Enrolled patients in the prospective study (RFA using separable clustered electrodes (Octopus®)) for treatment-naive HCC (n=79)
Device: Separable clustered electrodes
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.
Other Names:
  • Octopus®
No Intervention: Historical control group
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) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative 1-year local tumor progression (LTP) rate
Time Frame: 12 months after RFA
Comparison of rates of LTP in two groups in a year after RFA
12 months after RFA
Cumulative 2-year LTP rate
Time Frame: 24 months after RFA
Comparison of rates of LTP in two groups in two years after RFA
24 months after RFA
Cumulative 3-year LTP rate
Time Frame: 36 months after RFA
Comparison of rates of LTP in two groups in three years after RFA
36 months after RFA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year Recurrence free survival rate
Time Frame: 12 months after RFA
comparison of survival rate without disease progression in two groups
12 months after RFA
2-year Recurrence free survival rate
Time Frame: 24 months after RFA
comparison of survival rate without disease progression in two groups
24 months after RFA
3-year Recurrence free survival rate
Time Frame: 36 months after RFA
comparison of survival rate without disease progression in two groups
36 months after RFA

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major complication rate after RFA
Time Frame: 30 days after RFA
Description and comparison of the type and incidence of major complication after RFA are assessed according to Society of Interventional Radiology (SIR) grading system in two groups.
30 days after RFA
Technical success rate
Time Frame: 1 day after RFA
comparison of rates of sufficient ablative zone creation which covers the whole tumor on post-RFA computed tomography (CT) in each group
1 day after RFA

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2011

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 16, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 16, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-2016-0486

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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