HCC, Metastasis
Conditions
Keywords
RFA
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.
Interventions
DEVICEDSM
Monopolar RFA using dual switching mode (DSM)
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
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| local tumor progression (LTP) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| rate of intrahepatic distant recurrence (IDR) after RFA | 12 months |
| rate of extrahepatic metastasis (EM) after RFA | 12 months |
| Technical success on 1 months follow-up imaging after RFA (no residual/progressed tumor) | 1 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Real time US fusion image feasibility | 1 day after RFA procedure | success or failure of accurate fusion between US and pre-RFA cross sectional images |
| Immediate evaluation of ablative zone via visual assess and pre-and post-RFA images registration. | 12 months | 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) |
| Volume of ablative zone | 7 days | Volume of ablative zone on post-RFA CT or MRI in a mm3. |
| Number of complication of RFA | 6 months | incidence of any possible complication related with RFA |
| Maximal diameter of ablative zone | 7 day | Maximal diameter of ablative zone on post-RFA CT or MRI in a mm. |
| ablation time | 1 day | ablation time in a patient |
Countries
South Korea
Outcome results
None listed