Clinical trial NCT03005756: Needle Guiding Robot for Radiofrequency Ablation: Safety and Efficacy Study on Hepatocellular Carcinoma Patients
Official title: Single Center and Exploratory Investigator-initiated Trial to Evaluate the Safety and Efficacy of Needle Guiding Robot System for Radiofrequency Ablation in Hepatocellular Carcinoma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
name: Hyundai Heavy Industries
First posted: 2016-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total radiation exposure (DLP, mGy*cm)
timeFrame: At time of radiofrequency ablation
Secondary outcomes:
measure: Number of repositioning of radiofrequency electrode
timeFrame: At time of radiofrequency ablation
measure: Targeting error
timeFrame: At time of the 1st insertion of the electrode
measure: Procedure time
timeFrame: At time of radiofrequency ablation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
citation: Koethe Y, Xu S, Velusamy G, Wood BJ, Venkatesan AM. Accuracy and efficacy of percutaneous biopsy and ablation using robotic assistance under computed tomography guidance: a phantom study. Eur Radiol. 2014 Mar;24(3):723-30. doi: 10.1007/s00330-013-3056-y. Epub 2013 Nov 13.
citation: Abdullah BJ, Yeong CH, Goh KL, Yoong BK, Ho GF, Yim CC, Kulkarni A. Robot-assisted radiofrequency ablation of primary and secondary liver tumours: early experience. Eur Radiol. 2014 Jan;24(1):79-85. doi: 10.1007/s00330-013-2979-7. Epub 2013 Aug 9.
citation: Abdullah BJ, Yeong CH, Goh KL, Yoong BK, Ho GF, Yim CC, Kulkarni A. Robotic-assisted thermal ablation of liver tumours. Eur Radiol. 2015 Jan;25(1):246-57. doi: 10.1007/s00330-014-3391-7. Epub 2014 Sep 5.