Clinical trial NCT02745483: Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies: Follow-up Study
Official title: Prospective, Single-center, Single-arm, Clinical Trial Evaluating the Clinical Efficacy and Safety of a Novel Separable Cluster Electrode in Patients With Focal Liver Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: RFA
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 153
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the therapeutic outcomes and safety of the study patients who received radiofrequency ablation (RFA) using separable clustered electrodes with those of a matched historical control group who had received RFA using multiple internally-cooled electrodes.

Detailed description: Although RFA is widely used as a curative treatment option for a variety of liver malignancies, it is generally limited for treating tumors larger than 2 cm in diameter with a sufficient tumor-free margin. Thus, various strategies are employed to create a sufficient ablation zone such as internally cooled-electrodes, expandable electrodes and adaptation of switching mono/bipolar controllers. Despite that these attempts have created larger ablative zones in clinical and preclinical studies, the efficacy should be validated in terms of clinical outcome.

In this study, investigators evaluated the therapeutic outcomes and safety of RFA using separable clustered electrodes for treatment-naive hepatocellular carcinomas (HCCs) in comparison with RFA using multiple internally-cooled electrodes. The study group is a subgroup of our prospective study cohort (NCT02683538) and a control group is a matched historical group received RFA in our institution using multiple internally-cooled electrodes.

Eligibility criteria: Inclusion criteria

* HCC diagnosed on biopsy OR typical imaging features of HCC on CT or MRI according to AASLD guidelines
* 1-3 HCCs equal to or smaller than 5cm in the liver
* no direct contact with or invasion into the hepatic hilar structures or inferior vena cava
* treatment-naive HCC

Exclusion criteria

* patients with uncontrolled coagulopathy
* patients with Child-Pugh classification C
* patients with tumor invasion into the portal vein or hepatic vein
* extrahepatic spread

Primary outcomes:
measure: Cumulative 1-year local tumor progression (LTP) rate
timeFrame: 12 months after RFA
measure: Cumulative 2-year LTP rate
timeFrame: 24 months after RFA
measure: Cumulative 3-year LTP rate
timeFrame: 36 months after RFA
Secondary outcomes:
measure: 1-year Recurrence free survival rate
timeFrame: 12 months after RFA
measure: 2-year Recurrence free survival rate
timeFrame: 24 months after RFA
measure: 3-year Recurrence free survival rate
timeFrame: 36 months after RFA
Other outcomes:
measure: Major complication rate after RFA
timeFrame: 30 days after RFA
measure: Technical success rate
timeFrame: 1 day after RFA
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:
citation: Choi JW, Lee JM, Lee DH, Yoon JH, Suh KS, Yoon JH, Kim YJ, Lee JH, Yu SJ, Han JK. Switching Monopolar Radiofrequency Ablation Using a Separable Cluster Electrode in Patients with Hepatocellular Carcinoma: A Prospective Study. PLoS One. 2016 Aug 30;11(8):e0161980. doi: 10.1371/journal.pone.0161980. eCollection 2016.