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

NCT ID: NCT03699657

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-15
• Study Completion Date: 2019-06-19

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

RFA with DSM mode

RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.

Group Type: ACTIVE_COMPARATOR

DSM

Intervention Type: DEVICE

Monopolar RFA using dual switching mode (DSM)

Separable clustered electrodes

Intervention Type: DEVICE

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.

RFA with SSM mode

RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.

Group Type: ACTIVE_COMPARATOR

SSM

Intervention Type: DEVICE

Monopolar RFA using single switching mode (SSM)

Separable clustered electrodes

Intervention Type: DEVICE

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.

Interventions

DSM

Monopolar RFA using dual switching mode (DSM)

Intervention Type: DEVICE

SSM

Monopolar RFA using single switching mode (SSM)

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

Octopus®

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 %)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeong Min Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SNUH-2014-0279

Identifier Type: -

Identifier Source: org_study_id