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Trial Title:
Anatomical Radiofrequency Ablation for Small Hepatocellular Carcinoma
NCT ID:
NCT05580224
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Radiofrequency ablation
Description:
Radiofrequency ablation is performed for peripherally located small hepatocellular
carcinoma using combined energy delivery mode and triple cooled-wet electrodes. One of
three electrodes is placed across the 4th or 5th portal vein branches near the target
tumor which enables anatomical ablation of tumor.
Arm group label:
Patients with hepatocellular carcinoma (equal or less than 3 cm)
Summary:
The aim of this study is to investigate therapeutic outcomes of anatomical radiofrequency
ablation for peripherally located small hepatocellular carcinoma using combined energy
delivery mode and triple cooled-wet electrodes.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Child-Pugh class A or B7.
- Presence of chronic hepatitis B or liver cirrhosis.
- Patients with hepatocellular carcinomas diagnosed by histopathology or noninvasive
imaging-based diagnosis according to the Korean Liver Cancer Association-National
Cancer Center Korea guidelines.
- Patients with viable hepatocellular carcinoma after locoregional treatment diagnosed
by the Liver Imaging Reporting and Data System.
- Tumor location is less than 5 cm from liver capsule.
Exclusion Criteria:
- The number of tumor is three or more.
- Tumor size is over 3 cm.
- Tumor location is over 5 cm from liver capsule.
- Child-Pugh class B8-9 or C.
- Presence of macrovascular invasion and/or distant metastasis.
- Platelet count < 50,000 mm3, or international normalized ratio > 1.5 (prothrombin
time >1.5 × normal).
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:
October 4, 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/NCT05580224
