Hepatocellular Carcinoma
Conditions
Keywords
RFA
Brief summary
The purpose of this study is to compare the therapeutic outcomes and safety of the study patients who received radiofrequency ablation (RFA) using separable clustered electrodes with those of a matched historical control group who had received RFA using multiple internally-cooled electrodes.
Detailed description
Although RFA is widely used as a curative treatment option for a variety of liver malignancies, it is generally limited for treating tumors larger than 2 cm in diameter with a sufficient tumor-free margin. Thus, various strategies are employed to create a sufficient ablation zone such as internally cooled-electrodes, expandable electrodes and adaptation of switching mono/bipolar controllers. Despite that these attempts have created larger ablative zones in clinical and preclinical studies, the efficacy should be validated in terms of clinical outcome. In this study, investigators evaluated the therapeutic outcomes and safety of RFA using separable clustered electrodes for treatment-naive hepatocellular carcinomas (HCCs) in comparison with RFA using multiple internally-cooled electrodes. The study group is a subgroup of our prospective study cohort (NCT02683538) and a control group is a matched historical group received RFA in our institution using multiple internally-cooled electrodes.
Interventions
patients who signed informed consent, RFA was performed using separable clustered electrodes (Octopus®) in which, inter-tine distances can be flexibly adjusted by an operator.
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HCC diagnosed on biopsy OR typical imaging features of HCC on CT or MRI according to AASLD guidelines * 1-3 HCCs equal to or smaller than 5cm in the liver * no direct contact with or invasion into the hepatic hilar structures or inferior vena cava * treatment-naive HCC
Exclusion criteria
* patients with uncontrolled coagulopathy * patients with Child-Pugh classification C * patients with tumor invasion into the portal vein or hepatic vein * extrahepatic spread
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative 3-year LTP rate | 36 months after RFA | Comparison of rates of LTP in two groups in three years after RFA |
| Cumulative 2-year LTP rate | 24 months after RFA | Comparison of rates of LTP in two groups in two years after RFA |
| Cumulative 1-year local tumor progression (LTP) rate | 12 months after RFA | Comparison of rates of LTP in two groups in a year after RFA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year Recurrence free survival rate | 36 months after RFA | comparison of survival rate without disease progression in two groups |
| 1-year Recurrence free survival rate | 12 months after RFA | comparison of survival rate without disease progression in two groups |
| 2-year Recurrence free survival rate | 24 months after RFA | comparison of survival rate without disease progression in two groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Major complication rate after RFA | 30 days after RFA | Description and comparison of the type and incidence of major complication after RFA are assessed according to Society of Interventional Radiology (SIR) grading system in two groups. |
| Technical success rate | 1 day after RFA | comparison of rates of sufficient ablative zone creation which covers the whole tumor on post-RFA computed tomography (CT) in each group |
Countries
South Korea
Outcome results
None listed