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
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Seoul, Korea, Republic of
- Seoul National University Hospital
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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 |
|---|---|
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Experimental: Separable clustered electrodes
Enrolled patients in the prospective study (RFA using separable clustered electrodes (Octopus®)) for treatment-naive HCC (n=79)
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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:
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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) .
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cumulative 1-year local tumor progression (LTP) rate
Time Frame: 12 months after RFA
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Comparison of rates of LTP in two groups in a year after RFA
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12 months after RFA
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Cumulative 2-year LTP rate
Time Frame: 24 months after RFA
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Comparison of rates of LTP in two groups in two years after RFA
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24 months after RFA
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Cumulative 3-year LTP rate
Time Frame: 36 months after RFA
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Comparison of rates of LTP in two groups in three years after RFA
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36 months after RFA
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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1-year Recurrence free survival rate
Time Frame: 12 months after RFA
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comparison of survival rate without disease progression in two groups
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12 months after RFA
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2-year Recurrence free survival rate
Time Frame: 24 months after RFA
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comparison of survival rate without disease progression in two groups
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24 months after RFA
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3-year Recurrence free survival rate
Time Frame: 36 months after RFA
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comparison of survival rate without disease progression in two groups
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36 months after RFA
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Major complication rate after RFA
Time Frame: 30 days after RFA
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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.
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30 days after RFA
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Technical success rate
Time Frame: 1 day after RFA
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comparison of rates of sufficient ablative zone creation which covers the whole tumor on post-RFA computed tomography (CT) in each group
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1 day after RFA
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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
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