Clinical trial NCT03699657: Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: RFA
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 %)

Primary outcomes:
measure: Minimum diameter of ablative zone
timeFrame: 7 days after RFA
Secondary outcomes:
measure: Technical success rate
timeFrame: 1 month
measure: IDR rate
timeFrame: 24 months after RFA
measure: EM rate
timeFrame: 24 months after RFA
measure: 1-year local tumor progression (LTP)
timeFrame: 12 months after RFA
measure: 2-year LTP
timeFrame: 24 months after RFA
Other outcomes:
measure: Complication
timeFrame: 1 month after RFA
measure: Volume of ablative zone
timeFrame: 7 days after RFA
measure: Ablation time
timeFrame: 1 day
measure: Maximal diameter of ablative zone
timeFrame: 7 days after RFA
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: