Carcinoma, Hepatocellular
Conditions
Brief summary
The needle guiding robot helps targeting of radiofrequency ablation needles by matching computed tomography images and patients' bodies. Actual insertion of needles will be performed by doctors. This study evaluates the safety and efficacy of needle targeting on patients with hepatocellular carcinoma.
Detailed description
A robotic system has been developed that includes a needle-path planning system and a needle-guiding robot arm with computed tomography (CT) guidance. The robot consists of robot base, 5-axis robot arm with guiding end-effector and path-planner. Optical tracking system with a custom-designed registration jig is used for the spatial registration and validation. Advantages of the robotic system would be accurate targeting with diverse angulation of the robot arm in CT-guided tumor ablation. Furthermore, robotic intervention might potentially decrease procedure time and radiation exposure to patients. The purpose of this clinical trial with patients with hepatocelluar carcinoma is to assess the safety and efficacy of our CT-guided needle-guiding robot.
Interventions
DEVICENeedle guiding robot
This intervention is to evaluate the safety and efficacy of a needle guiding robot for assisting targeting in CT-guided radiofrequency ablation of hepatocelluar carcinomas.
Sponsors
Ministry of Health & Welfare, Korea
Hyundai Heavy Industries
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with up to three Hepatocellular carcinomas (HCC) with no single HCC larger than 3 cm * Candidates for CT-guided radiofrequency ablation of HCC * Child-Pugh class A or B
Exclusion criteria
* Patients with untreatable/unmanageable coagulopathy * Patients who are allergic to CT contrast media * Patients with vascular invasion or extrahepatic metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total radiation exposure (DLP, mGy*cm) | At time of radiofrequency ablation | Sum of radiation exposures measured during the radiofrequency ablation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure time | At time of radiofrequency ablation | Total period of time from the installation of needle guiding robot to patient's transfer after the procedure |
| Number of repositioning of radiofrequency electrode | At time of radiofrequency ablation | Number of repositioning of radiofrequency electrode in order to correct targeting discrepancy untile properly placed in to the target tumor |
| Targeting error | At time of the 1st insertion of the electrode | Distance between the target and the electrode tip |
Countries
South Korea
Contacts
Primary ContactSang Do Lee, MD, PhD
Outcome results
None listed