Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies
1 other identifier
interventional
196
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hepatocellular-carcinoma
Started Nov 2011
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 12, 2016
CompletedFirst Posted
Study publicly available on registry
February 17, 2016
CompletedApril 5, 2016
April 1, 2016
1.7 years
February 12, 2016
April 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major complication rate after Radiofrequency ablation (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 Outcomes (2)
Technical success
1 day after RFA
Local control rate
12 months after RFA
Other Outcomes (2)
total procedure time
1 day after RFA
Ablative zone volume
1 day after RFA
Study Arms (1)
Separable cluster electrode
EXPERIMENTALradiofrequency ablation (RFA) using separable cluster electrode in switching monopolar mode.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- \~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
You may not qualify if:
- Patients with uncontrolled coagulopathy
- Patients with Child-Pugh classification C
- Patients with tumor invasion in major portal vein or hepatic vein branch
- Extrahepatic metastasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong Min Lee, MD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 12, 2016
First Posted
February 17, 2016
Study Start
November 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2014
Last Updated
April 5, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share