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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03806218
• Other study ID #: SNUH-2015-0401
• Status: Completed
• Phase: N/A
• Start date: May 16, 2015
• Est. completion date: February 12, 2019

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: February 12, 2019
• Est. primary completion date: May 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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 %)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• Bipolar RFA
Bipolar RFA in which RF currents flow between two electrodes
• SM-RFA
Monopolar RFA using multiple electrodes with switching mode
• Twin 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
• 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	3 days after RFA
Other	Ablation time	RFA procedure time in each patient.	1 day
Primary	Minimum diameter of ablation zone per unit time	Minimum diameter of ablative zone per unit time on post-RFA CT or MRI in a mm.	3 days after RFA
Secondary	Technique efficacy	Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)	1 month after RFA
Secondary	IDR rate	Cumulative intrahepatic distant recurrence (IDR) rate over 2 years after RFA	12 months, 24 months after RFA
Secondary	EM rate	Cumulative extrahepatic metastasis (EM) rate over 2 years after RFA	12 months, 24 months after RFA
Secondary	Local tumor progression (LTP)	Cumulative LTP rates in two groups in 2 years after RFA	12 months, 24 months after RFA