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Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies

Primary Purpose

Hepatocellular Carcinoma, Metastasis, Cholangiocarcinoma

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Separable cluster electrode (Octopus®)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring RFA

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hepatic malignancies diagnosed on biopsy OR
  • Typical imaging features of hepatocellular carcinoma (HCC) on computed tomography (CT) or magnetic resonance imaging (MRI) according to AASLD guideline
  • Typical imaging feature of metastasis on CT or MRI AND
  • 1~5 tumors equal to or smaller than 5cm in the liver
  • no direct contact with or invasion into the hepatic hilar structures or inferior vena cava (IVC)
  • Eastern Cooperative Oncology Group performance status of 0
  • Patients who signed informed consent

Exclusion Criteria: Patients with any of followings are excluded.

  • Patients with uncontrolled coagulopathy
  • Patients with Child-Pugh classification C
  • Patients with tumor invasion in major portal vein or hepatic vein branch
  • Extrahepatic metastasis

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Separable cluster electrode

Arm Description

radiofrequency ablation (RFA) using separable cluster electrode in switching monopolar mode.

Outcomes

Primary Outcome Measures

Major complication rate after Radiofrequency ablation (RFA)
Rates of major complication according to Society of Interventional Radiology (SIR) grading system, which refers to an event that leads to substantial morbidity and disability (SIR classification C-E).

Secondary Outcome Measures

Technical success
Technical success addresses that the tumor was treated according to protocol and completely covered by ablative zone on pre-RFA image and post-RFA image side-by-side comparison.
Local control rate
Rate of local tumor progression after RFA

Full Information

First Posted
February 12, 2016
Last Updated
April 2, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02683538
Brief Title
Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies
Official Title
Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the clinical feasibility and short-term outcome of switching monopolar RFA using a separable cluster electrode in patients with primary and secondary liver malignancies.
Detailed Description
Radiofrequency ablation (RFA) is one of minimal invasive treatment methods and it has been showing comparable overall survival with surgery in early or small hepatocellular carcinomas (HCCs) and better cost-effectiveness. However, it is suffering from high local tumor progression (LTP) rate. To reduce LTP rate, creation of large ablative zone has been attempted in various strategies. A separable cluster electrode is a new type of RFA electrode. It consists of three individual applicators and the applicators can be incorporated as a single handle such as a cluster electrode, and can be separated as three electrodes, depending on operators' needs. It allows high flexibility to operators and the preclinical results were promising. Herein, we want to evaluate the clinical feasibility of the electrodes by observing major complication rates, technical success rate and 12-months LTP rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Metastasis, Cholangiocarcinoma
Keywords
RFA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Separable cluster electrode
Arm Type
Experimental
Arm Description
radiofrequency ablation (RFA) using separable cluster electrode in switching monopolar mode.
Intervention Type
Device
Intervention Name(s)
Separable cluster electrode (Octopus®)
Intervention Description
Patients undergo RFA under ultrasound guidance, and separable cluster electrodes are used for RFA in monopolar switching mode, using multiple overlapping technique to create larger ablative zones.
Primary Outcome Measure Information:
Title
Major complication rate after Radiofrequency ablation (RFA)
Description
Rates of major complication according to Society of Interventional Radiology (SIR) grading system, which refers to an event that leads to substantial morbidity and disability (SIR classification C-E).
Time Frame
30 days after RFA
Secondary Outcome Measure Information:
Title
Technical success
Description
Technical success addresses that the tumor was treated according to protocol and completely covered by ablative zone on pre-RFA image and post-RFA image side-by-side comparison.
Time Frame
1 day after RFA
Title
Local control rate
Description
Rate of local tumor progression after RFA
Time Frame
12 months after RFA
Other Pre-specified Outcome Measures:
Title
total procedure time
Description
total procedure time per patients was recorded.
Time Frame
1 day after RFA
Title
Ablative zone volume
Description
ablative zone volume measurement for each tumor on post-RFA cross sectional imaging
Time Frame
1 day after RFA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hepatic malignancies diagnosed on biopsy OR Typical imaging features of hepatocellular carcinoma (HCC) on computed tomography (CT) or magnetic resonance imaging (MRI) according to AASLD guideline Typical imaging feature of metastasis on CT or MRI AND 1~5 tumors equal to or smaller than 5cm in the liver no direct contact with or invasion into the hepatic hilar structures or inferior vena cava (IVC) Eastern Cooperative Oncology Group performance status of 0 Patients who signed informed consent Exclusion Criteria: Patients with any of followings are excluded. Patients with uncontrolled coagulopathy Patients with Child-Pugh classification C Patients with tumor invasion in major portal vein or hepatic vein branch Extrahepatic metastasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies

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