Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®)

Seoul National University

Status: Completed

Conditions: Metastasis; HCC

Treatments: Device: DSM; Device: separable clustered electrode

Study type: Interventional

Funder types: Other

Identifiers

NCT02675881

SNUH-2013-1441

Details and patient eligibility

About

Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).

A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.

Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group.

Full description

Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).

A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.

Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group using propensity score matching.

Enrollment: 60 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hepatocellular carcinoma (according to AASLD guideline or LI-RADS)
• histologically confirmed HCC
• histologically confirmed or typical imaging feature of colorectal cancer liver metastasis in patients with colorectal cancer AND
• equal to or larger than 2cm, equal to or smaller than 5cm
• available cross-sectional liver imaging within 30 days before RFA
• signed informed consent

Exclusion criteria

• history of local treatment on the index tumor
• more than three tumors in a patient
• tumors in central portion of portal vein or hepatic vein
• Child-Pugh class C
• vascular invasion by tumors
• uncorrected coagulopathy
• presence of multiple extrahepatic metastases

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

RFA DSM

Active Comparator group

Description:

Eligible patients who undergo RFA using DSM and separable clustered electrodes.

Treatment:

Device: DSM

Device: separable clustered electrode

RFA SSM

No Intervention group

Description:

Historical control group consisted of patients underwent RFA in our institution with single switching mode (SSM) and single/ or multiple clustered electrodes.