Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699657
• Other study ID #: SNUH-2014-0279
• Status: Completed
• Phase: N/A
• Start date: December 15, 2014
• Est. completion date: June 19, 2019

Study information

• Verified date: March 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 19, 2019
• Est. primary completion date: April 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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 %)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• DSM
Monopolar RFA using dual switching mode (DSM)
• SSM
Monopolar RFA using single switching mode (SSM)
• Separable clustered electrodes
A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complication	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.	1 month after RFA
Other	Volume of ablative zone	Volume of ablative zone on post-RFA CT or MRI in a mm3.	7 days after RFA
Other	Ablation time	RFA procedure time in each patient.	1 day
Other	Maximal diameter of ablative zone	Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.	7 days after RFA
Primary	Minimum diameter of ablative zone	Minimum diameter of ablative zone on post-RFA CT or MRI in a mm.	7 days after RFA
Secondary	Technical success rate	Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)	1 month
Secondary	IDR rate	Cumulative intrahepatic distant recurrence (IDR) rate over two years after RFA	24 months after RFA
Secondary	EM rate	Cumulative extrahepatic metastasis (EM) rate over two years after RFA	24 months after RFA
Secondary	1-year local tumor progression (LTP)	Comparison of rates of LTP in two groups in a year after RFA	12 months after RFA
Secondary	2-year LTP	Comparison of rates of LTP in two groups in two years after RFA	24 months after RFA