Hepatocellular Carcinoma
Conditions
Brief 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.
Interventions
PROCEDURERadiofrequency ablation
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Immediately after radiofrequency ablation | Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone. |
| Local tumor progression rate | 12 months after radiofrequency ablation | Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication after radiofrequency ablation | Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation | Post-radiofrequency ablation complications were defined as problems noted within 1 month after RFA as well as additional complications identified on follow-up imaging and judged to be likely caused by radiofrequency ablation. |
| Recurrence-free survival | 12 months after radiofrequency ablation | Recurrence-free survival was defined as the interval between radiofrequency ablation and the date of any type of recurrence or the last follow-up date if there was no recurrence. |
Countries
South Korea
Contacts
Primary ContactHyun Hee Lee
Backup ContactJae Hyun Kim, M.D.
Outcome results
None listed