Radiofrequency Ablation Using Cooled-Wet Electrode

Metastasis Clinical Trial

Official title:

Switching Bipolar Radiofrequency Ablation Using Cooled-Wet Electrode for Treatment of Hepatocellular Carcinoma: A Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675894
• Other study ID #: SNUH-2013-2283
• Status: Completed
• Phase: N/A
• Start date: April 14, 2014
• Est. completion date: April 24, 2018

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine safety, ablative zone, technical success rate and early safety data of recently introduced cool-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors.

Description:

To determine safety, ablative zone, technical success rate and early safety data (12 months local tumor progression rate) of recently introduced cooled-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors in comparison with currently used separable clustered electrode in our institution. Owing to tissue cooling effect of internally cooled-wet electrode can be used in switching bipolar mode. Patients would be randomized into two groups (cool-wet electrode group and separable clustered electrode in switching monopolar mode). The results from this preliminary study would be used for main study to compare the efficacy and safety data between two electrodes in the future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: April 24, 2018
• Est. primary completion date: January 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria: all conditions have to be fulfilled.

• Diagnosed with HCC (1~5cm) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
• liver metastasis histologically confirmed or characteristic findings on cross-sectional imaging
• signed informed consent
• treatment naive index tumor (no history of local treatment for an index tumor)

Exclusion Criteria:

• more than three tumors in a patients
• tumor size larger than 5cm
• tumor attaches to central portal vein or hepatic vein
• Child-Pugh classification C
• uncorrected coagulopathy
• presence of extrahepatic metastases

Related Conditions & MeSH terms

• HCC
• Metastasis
• Neoplasm Metastasis

Intervention

Device:
• cooled-wet electrode
RFA is performed using three cooled-wet electrodes in switching bipolar mode. The electrode is anticipated to reduce tissue resistance by releasing small amount of saline during the procedure, which may lead larger ablative volume by delivering more RF energy.
• separable clustered electrode
RFA is performed using separable clustered electrode in switching monopolar mode.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Medical Research Collaborating Center, RF medical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	US/CT or MR fusion success rate	RFA is performed under real time US guidance and US is fused with pre-RFA CT or MRI before ablation of the index tumor. US/CT or US/MR fusion quality is assessed by an operator.	1 day
Other	Immediate assess of technique success rate	After performing RFA, patients were transferred CT unit to confirm immediate technique success. It is performed in both a) visual inspection using pre-and post-RFA images side-by-side comparison and b) software assisted inspection which register pre-and post-RFA scans. The results would be used to perform additional treatment (2nd look RFA).	2 days
Primary	LTP	cumulating local tumor progression rate over 2- year after RFA	24 months
Secondary	Technical success rate	technical success rate on 1 month follow-up which indicates no residual tumor on cross-sectional imaging (CT, MRI)	1 months
Secondary	IDR rate	cumulating intrahepatic distant recurrence (IDR) rate over 2- year after RFA	24 months
Secondary	EM rate	cumulating extrahepatic metastasis (EM) rate over 2- year after RFA	24 months
Secondary	Maximal diameter of ablative zone	Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.	7 day
Secondary	ablation time	RFA procedure time in each patient.	1 day
Secondary	Complication	all complication rate and grades (according to Clavien system from I to III) related with RFA procedure	12 months
Secondary	Volume of ablative zone	Volume of ablative zone on post-RFA CT or MRI in a mm3.	7 days