Hepatocellular Carcinoma
Conditions
Keywords
RFA
Brief summary
This study was conducted to prospectively compare the efficacy, safety and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) with those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC).
Detailed description
Recently, dual switching monopolar RFA (DSM-RFA) was developed to enhance further the efficiency of the single switching monopolar RFA (SSM-RFA) in creating ablation zone; Yoon et al. reported that DSM-RFA allowed significantly greater RF energy delivery to target tissue per given time, and then, created significantly larger ablation zone than the SSM-RFA in ex vivo and in vivo animal experiments. A retrospective comparative study by Choi et al. reported that the DSM-RFA created significantly larger ablation volume than, but seemed to show similar LTP rate to the SSM-RFA. Still, whether the physical differences between SSM-RFA and DSM-RFA translate into better clinical outcomes remains an open question. Regarding that the choice of equipment is an essential factor to consider in planning image-guided tumor ablation procedure, we thought that the prospective comparison between DSM-RFA and the SSM-RFA would be helpful for improving results of RFA. Therefore, the purpose of this study was to prospectively compare the efficacy, safety and mid-term outcomes of DSM-RFA with those of conventional SSM-RFA in the treatment of HCC.
Interventions
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with HCC (\>= 1.5cm and \< 5cm in maximal diameter) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA * no history of previous locoregional treatment
Exclusion criteria
* more than three HCC nodules * tumors abutting to the central portal vein or hepatic vein with a diameter \> 5 mm * Child-Pugh class C * tumors with major vascular invasion * extrahepatic metastasis * severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or INR prolongation of more than 50 %)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimum diameter of ablative zone | 7 days after RFA | Minimum diameter of ablative zone on post-RFA CT or MRI in a mm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IDR rate | 24 months after RFA | Cumulative intrahepatic distant recurrence (IDR) rate over two years after RFA |
| Technical success rate | 1 month | Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor) |
| EM rate | 24 months after RFA | Cumulative extrahepatic metastasis (EM) rate over two years after RFA |
| 1-year local tumor progression (LTP) | 12 months after RFA | Comparison of rates of LTP in two groups in a year after RFA |
| 2-year LTP | 24 months after RFA | Comparison of rates of LTP in two groups in two years after RFA |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ablation time | 1 day | RFA procedure time in each patient. |
| Maximal diameter of ablative zone | 7 days after RFA | Maximal diameter of ablative zone on post-RFA CT or MRI in a mm. |
| Volume of ablative zone | 7 days after RFA | Volume of ablative zone on post-RFA CT or MRI in a mm3. |
| Complication | 1 month 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. |
Countries
South Korea
Outcome results
None listed