Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies

April 2, 2016 updated by: Jeong Min Lee, Seoul National University Hospital
The purpose of this study is to evaluate the clinical feasibility and short-term outcome of switching monopolar RFA using a separable cluster electrode in patients with primary and secondary liver malignancies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Radiofrequency ablation (RFA) is one of minimal invasive treatment methods and it has been showing comparable overall survival with surgery in early or small hepatocellular carcinomas (HCCs) and better cost-effectiveness. However, it is suffering from high local tumor progression (LTP) rate. To reduce LTP rate, creation of large ablative zone has been attempted in various strategies. A separable cluster electrode is a new type of RFA electrode. It consists of three individual applicators and the applicators can be incorporated as a single handle such as a cluster electrode, and can be separated as three electrodes, depending on operators' needs. It allows high flexibility to operators and the preclinical results were promising. Herein, we want to evaluate the clinical feasibility of the electrodes by observing major complication rates, technical success rate and 12-months LTP rate.

Study Type

Interventional

Enrollment (Actual)

196

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:

  • Hepatic malignancies diagnosed on biopsy OR
  • Typical imaging features of hepatocellular carcinoma (HCC) on computed tomography (CT) or magnetic resonance imaging (MRI) according to AASLD guideline
  • Typical imaging feature of metastasis on CT or MRI AND
  • 1~5 tumors equal to or smaller than 5cm in the liver
  • no direct contact with or invasion into the hepatic hilar structures or inferior vena cava (IVC)
  • Eastern Cooperative Oncology Group performance status of 0
  • Patients who signed informed consent

Exclusion Criteria: Patients with any of followings are excluded.

  • Patients with uncontrolled coagulopathy
  • Patients with Child-Pugh classification C
  • Patients with tumor invasion in major portal vein or hepatic vein branch
  • Extrahepatic metastasis

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Separable cluster electrode
radiofrequency ablation (RFA) using separable cluster electrode in switching monopolar mode.
Device: Separable cluster electrode (Octopus®)
Patients undergo RFA under ultrasound guidance, and separable cluster electrodes are used for RFA in monopolar switching mode, using multiple overlapping technique to create larger ablative zones.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major complication rate after Radiofrequency ablation (RFA)
Time Frame: 30 days after RFA
Rates of major complication according to Society of Interventional Radiology (SIR) grading system, which refers to an event that leads to substantial morbidity and disability (SIR classification C-E).
30 days after RFA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: 1 day after RFA
Technical success addresses that the tumor was treated according to protocol and completely covered by ablative zone on pre-RFA image and post-RFA image side-by-side comparison.
1 day after RFA
Local control rate
Time Frame: 12 months after RFA
Rate of local tumor progression after RFA
12 months after RFA

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
total procedure time
Time Frame: 1 day after RFA
total procedure time per patients was recorded.
1 day after RFA
Ablative zone volume
Time Frame: 1 day after RFA
ablative zone volume measurement for each tumor on post-RFA cross sectional imaging
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

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, 2013

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 12, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 17, 2016

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 2, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-0364

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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