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

Metastasis Clinical Trial

Official title:

Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®) for Treatment of Focal Liver Malignancies: A Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675881
• Other study ID #: SNUH-2013-1441
• Status: Completed
• Phase: N/A
• Start date: August 5, 2013
• Est. completion date: July 13, 2015

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 13, 2015
• Est. primary completion date: April 8, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• HCC
• Metastasis
• Neoplasm Metastasis

Intervention

Device:
• DSM
Monopolar RFA using dual switching mode (DSM)
• separable clustered electrode
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	Number of complication of RFA	incidence of any possible complication related with RFA	6 months
Other	Maximal diameter of ablative zone	Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.	7 day
Other	ablation time	ablation time in a patient	1 day
Other	Real time US fusion image feasibility	success or failure of accurate fusion between US and pre-RFA cross sectional images	1 day after RFA procedure
Other	Immediate evaluation of ablative zone via visual assess and pre-and post-RFA images registration.	Prediction of LTP by classifying patients according to assessing ablative margin in each method on a four point scale (1: residual tumor, 4: ablative margin equal to or larger than 5mm)	12 months
Other	Volume of ablative zone	Volume of ablative zone on post-RFA CT or MRI in a mm3.	7 days
Primary	local tumor progression (LTP)		12 months
Secondary	Technical success on 1 months follow-up imaging after RFA (no residual/progressed tumor)		1 months
Secondary	rate of intrahepatic distant recurrence (IDR) after RFA		12 months
Secondary	rate of extrahepatic metastasis (EM) after RFA		12 months