Overview

This trial is active, not recruiting.

Conditions hcc, metastasis
Treatments dsm, separable clustered electrode
Sponsor Seoul National University Hospital
Start date July 2013
End date July 2015
Trial size 60 participants
Trial identifier NCT02675881, SNUH-2013-1441

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Eligible patients who undergo RFA using DSM and separable clustered electrodes.
dsm
Monopolar RFA using dual switching mode (DSM)
separable clustered electrode Octopus(R)
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.
(No Intervention)
Historical control group consisted of patients underwent RFA in our institution with single switching mode (SSM) and single/ or multiple clustered electrodes.

Primary Outcomes

Measure
local tumor progression (LTP)
time frame: 12 months

Secondary Outcomes

Measure
Technical success on 1 months follow-up imaging after RFA (no residual/progressed tumor)
time frame: 1 months
rate of intrahepatic distant recurrence (IDR) after RFA
time frame: 12 months
rate of extrahepatic metastasis (EM) after RFA
time frame: 12 months

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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

Additional Information

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
Principal investigator Jeong Min Lee, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.