Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Minimum diameter of ablative zone
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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 %)
Arms & Interventions
RFA with DSM mode
RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.
Intervention: DSM (Device)
RFA with DSM mode
RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.
Intervention: Separable clustered electrodes (Device)
RFA with SSM mode
RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.
Intervention: Separable clustered electrodes (Device)
RFA with SSM mode
RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.
Intervention: SSM (Device)
Outcomes
Primary Outcomes
Minimum diameter of ablative zone
Time Frame: 7 days after RFA
Minimum diameter of ablative zone on post-RFA CT or MRI in a mm.
Secondary Outcomes
- 1-year local tumor progression (LTP)(12 months after RFA)
- Technical success rate(1 month)
- IDR rate(24 months after RFA)
- EM rate(24 months after RFA)
- 2-year LTP(24 months after RFA)
Investigators
Jeong Min Lee
Professor
Seoul National University Hospital