Radiofrequency Ablation for Hepatocellular Carcinoma Using Octopus MP Electrodes
Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus MP Electrodes or Octopus Electrodes With Adjustable Tips: A Prospective Observational Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Locations
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-
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Seoul, South Korea
- Seoul National University Hospital
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Child-Pugh Class A or B
- chronic hepatitis B or chronic hepatitis C or liver cirrhosis
- presence of hepatocellular carcinoma (HCC) after confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to the Korean Liver Cancer Study Group (KLCSG)-National Cancer Center (NCC) Korea practice guidelines.
- up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment.
Exclusion Criteria:
- number of recurrent HCCs, more than 3
- largest HCC size over 3 cm
- presence of vascular invasion by HCC
- platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
- presence of extrahepatic metastasis
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adjacent organ thermal injury rate
Time Frame: Immediately after radiofrequency ablation
|
Evaluate adjacent organ thermal injury rate by immediate follow-up computed tomography after radiofrequency ablation.
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Immediately after radiofrequency ablation
|
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Local tumor progression rates
Time Frame: 1 and 2 years after radiofrequency ablation
|
local tumor progression (LTP) rates , defined as new tumor foci at the ablation margin after initial complete ablation, as confirmed by a consensus of two radiologists on follow-up imaging
|
1 and 2 years after radiofrequency ablation
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Digestive System Neoplasms
- Digestive System Diseases
- Liver Diseases
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Therapeutics
- Surgical Procedures, Operative
- Ablation Techniques
- Radiofrequency Therapy
- Radiofrequency Ablation
Other Study ID Numbers
Other Study ID Numbers
- 2208-116-1351
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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