Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Major complication rate after Radiofrequency ablation (RFA) [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).
Secondary Outcome Measures
- Technical success [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.
- Local control rate [12 months after RFA]
Rate of local tumor progression after RFA
Other Outcome Measures
- total procedure time [1 day after RFA]
total procedure time per patients was recorded.
- Ablative zone volume [1 day after RFA]
ablative zone volume measurement for each tumor on post-RFA cross sectional imaging
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Hepatic malignancies diagnosed on biopsy OR
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Typical imaging features of hepatocellular carcinoma (HCC) on computed tomography (CT) or magnetic resonance imaging (MRI) according to AASLD guideline
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Typical imaging feature of metastasis on CT or MRI AND
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1~5 tumors equal to or smaller than 5cm in the liver
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no direct contact with or invasion into the hepatic hilar structures or inferior vena cava (IVC)
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Eastern Cooperative Oncology Group performance status of 0
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Patients who signed informed consent
Exclusion Criteria: Patients with any of followings are excluded.
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Patients with uncontrolled coagulopathy
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Patients with Child-Pugh classification C
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Patients with tumor invasion in major portal vein or hepatic vein branch
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Extrahepatic metastasis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
- Principal Investigator: Jeong Min Lee, MD, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2011-0364