Clinical trial NCT02675881: Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HCC
Metastasis
Keywords: RFA
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: local tumor progression (LTP)
timeFrame: 12 months
Secondary outcomes:
measure: Technical success on 1 months follow-up imaging after RFA (no residual/progressed tumor)
timeFrame: 1 months
measure: rate of intrahepatic distant recurrence (IDR) after RFA
timeFrame: 12 months
measure: rate of extrahepatic metastasis (EM) after RFA
timeFrame: 12 months
Other outcomes:
measure: Number of complication of RFA
timeFrame: 6 months
measure: Maximal diameter of ablative zone
timeFrame: 7 day
measure: ablation time
timeFrame: 1 day
measure: Real time US fusion image feasibility
timeFrame: 1 day after RFA procedure
measure: Immediate evaluation of ablative zone via visual assess and pre-and post-RFA images registration.
timeFrame: 12 months
measure: Volume of ablative zone
timeFrame: 7 days
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: