Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Device: DSMDevice: SSMDevice: Separable clustered electrodes
- Registration Number
- NCT03699657
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- 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
- 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 %)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RFA with DSM mode DSM RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit. RFA with DSM mode Separable clustered electrodes RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit. RFA with SSM mode SSM RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit. RFA with SSM mode Separable clustered electrodes RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.
- Primary Outcome Measures
Name Time Method Minimum diameter of ablative zone 7 days after RFA Minimum diameter of ablative zone on post-RFA CT or MRI in a mm.
- Secondary Outcome Measures
Name Time Method 1-year local tumor progression (LTP) 12 months after RFA Comparison of rates of LTP in two groups in a year after RFA
Technical success rate 1 month Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)
IDR rate 24 months after RFA Cumulative intrahepatic distant recurrence (IDR) rate over two years after RFA
EM rate 24 months after RFA Cumulative extrahepatic metastasis (EM) rate over two years after RFA
2-year LTP 24 months after RFA Comparison of rates of LTP in two groups in two years after RFA
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of