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Trial Title:
Radiofrequency Ablation for Hepatocellular Carcinoma Using Octopus MP Electrodes
NCT ID:
NCT05666271
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Radiofrequency ablation
Description:
Radiofrequency ablation will be performed by using the Octopus MP electrodes. It is a
method of directly measuring the temperature near the surrounding tissue of the target
tumor using the Octopus MP electrode, and stopping ablation when the temperature rises
above 60 degrees to prevent adjacent organ (gallbladder, gastrointestinal tracts,
diaphragm, and heart). If the shape of the tumor is elliptical or irregular rather than
circular, using an adjustable tip that can change the length of the active tip of the
electrode according to the size of the tumor has the advantage of tailoring the ablation
zone.
Summary:
This study is to investigate the therapeutic effect and treatment results of
radiofrequency ablation using the Octopus MP electrode capable of temperature monitoring
and drug injection and a variable-length electrode for treatment of small hepatocellular
carcinomas (≤ 3cm).
Criteria for eligibility:
Study pop:
Patients who have been referred for radiofrequency ablation for the treatment of small
hepatocellular carcinomas (equal or less than 3 cm) located in the periphery of the liver
(within 5 cm from the liver capsule) on preprocedural computed tomography or magnetic
resonance imaging.
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hyun Hee Lee
Phone:
82-2-2072-4177
Email:
redlion55@naver.com
Investigator:
Last name:
Jeong Min Lee, MD, PhD
Email:
Principal Investigator
Start date:
August 29, 2022
Completion date:
August 30, 2024
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05666271
