o-Touch” Radiofrequency Ablation Using Octopus Electrodes and Combined RF Energy Delivery Mode for Small Hepatocellular Carcinoma (= 3cm)
- Conditions
- Neoplasms
- Registration Number
- KCT0005151
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
1. Final Enrollment Number: 159 Participants:158 Dropped: 6 2. Efficacy: (Local recurrence rates 12 months after treatment ) 3. Adverse Event :2022-11-21 Radio-Frequency Ablation -> 2022.11.23 RUQ pain ->22.11.24 yellowish sputum ->PCD insertion (2022.11.28) : PI determined that this was a complication of RFA. 4. Brief Summary Efficacy (Local recurrence rates 12 months after treatment ) Seoul National University Hospital : 0.77 % (2/259) Samsung Medical Center Hospita: 1.74% (4/230) Chosun University Hospita: 2.74% (2/73)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 159
(1) Patients who agreed to the protocol requirements and submitted consent
(2) 20 years old-85 years old
(3) Child-Pugh Class A or B7
(4) Among patients with cirrhosis, patients suspected of having HCC of 1-3 cm in size on MDCT or MRI performed within 60 days, and are going to undergo RFA
(1) When the number of malignant liver tumors is 2 or more
(2) When the maximum size of the tumor exceeds 3 cm (diffuse carcinoma)
(3) Patients with previous medical history of liver cancer who have recurrent liver cancer within 2 years
(4) When the tumor adheres to the portal vein or hepatic vein of 5 mm or larger
(5) When the tumor is not visible even under CEUS-fusion image guidance
(6) severe liver failure (Child-Pugh class B8, B9 or C)
(7) In case of invasion of hepatic vessels by HCC
(8) Severe coagulopathy (if platelet is below 50,000/mm3, INR is over 50% prolongation)
(9) When there is metastasis outside the liver
(10) A situation where the probability of obtaining appropriate data suitable for the research purpose is very low
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ocal recurrence rates
- Secondary Outcome Measures
Name Time Method