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Trial Title:
Clinical Feasibility of Microwave Ablation Using Two Channel Microwave Generator and Two Antennas for Small Hepatocellular Carcinoma
NCT ID:
NCT06086002
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
Microwave ablation
Description:
Microwave ablation will be performed by using single antenna (Emprint, Medtronic) with
overlapping ablation or two antennas (Starwave, STARmed) with simultaneous ablation.
Arm group label:
Overlapping ablation with single antenna
Arm group label:
Simultaneous ablation with two antennas
Summary:
To compare safety and efficacy of microwave ablation with simultaneous ablation using two
antennas versus overlapping ablation with single antenna for small hepatocellular
carcinoma
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Child-Pugh Class A or B
- chronic hepatitis B or chronic hepatitis C or liver cirrhosis
- presence of hepatocellular carcinoma (HCC) confirmed by pathology or imaging studies
including contrast enhanced computed tomography (CT) or magnetic resonance imaging
(MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018
- single lesion less than or equal to 3 cm, or 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, equal or more than 3
- largest recurrent HCC size over 3 cm
- presence of vascular invasion by HCC
- diffuse infiltrative type HCC
- HCCs located less than 5 mm from central bile duct or large portal vein or large
hepatic vein
- 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:
September 18, 2023
Completion date:
December 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/NCT06086002
