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Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC

Radiofrequency Ablation Using Internally Cooled Wet Electrodes in Bipolar Mode for the Treatment of Recurrent Hepatocellular Carcinoma After Locoregional Treatment: A Randomized Prospective Comparative Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03806218
Enrollment
77
Registered
2019-01-16
Start date
2015-05-16
Completion date
2019-02-12
Last updated
2020-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

RFA

Brief summary

This study was conducted to provide preliminary data for the main trial to compare efficacy between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and switching monopolar RFA using separable clustered electrodes in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.

Interventions

DEVICEBipolar RFA

Bipolar RFA in which RF currents flow between two electrodes

DEVICESM-RFA

Monopolar RFA using multiple electrodes with switching mode

DEVICETwin internally cooled-wet electrodes

Saline-enhanced twin internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity

DEVICESeparable 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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* radiologic or pathologic diagnosis of HCC recurrence after locoregional treatment * HCC nodules measuring 1 cm or larger and smaller than 5 cm

Exclusion criteria

* more than three HCC nodules * tumors with major vascular invasion or abutment to the central portal or hepatic vein with a diameter \> 5mm * extrahepatic metastasis * Child-Pugh class C * severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or prothrombin time international normalized ratio (PT-INR) prolongation of more than 50 %)

Design outcomes

Primary

MeasureTime frameDescription
Minimum diameter of ablation zone per unit time3 days after RFAMinimum diameter of ablative zone per unit time on post-RFA CT or MRI in a mm.

Secondary

MeasureTime frameDescription
IDR rate12 months, 24 months after RFACumulative intrahepatic distant recurrence (IDR) rate over 2 years after RFA
Technique efficacy1 month after RFATechnical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)
EM rate12 months, 24 months after RFACumulative extrahepatic metastasis (EM) rate over 2 years after RFA
Local tumor progression (LTP)12 months, 24 months after RFACumulative LTP rates in two groups in 2 years after RFA

Other

MeasureTime frameDescription
Ablation time1 dayRFA procedure time in each patient.
Volume of ablative zone3 days after RFAVolume of ablative zone on post-RFA CT or MRI in a mm3
Complication1 month after RFADescription 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026