Robotic needle insertion during computed tomography fluoroscopy–guided biopsy: prospective first-in-human feasibility trial
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This was a prospective, first-in-human trial to evaluate the feasibility and safety of insertion of biopsy introducer needles with our robot during CT fluoroscopy–guided biopsy in humans.
Materials and methods
Eligible patients were adults with a lesion ≥ 10 mm in an extremity or the trunk requiring pathological diagnosis with CT fluoroscopy–guided biopsy. Patients in whom at-risk structures were located within 10 mm of the scheduled needle tract were excluded. Ten patients (4 females and 6 males; mean [range] age, 72 [52–87] years) with lesions (mean [range] maximum diameter, 28 [14–52] mm) in the kidney (n = 4), lung (n = 3), mediastinum (n = 1), adrenal gland (n = 1), and muscle (n = 1) were enrolled. The biopsy procedure involved robotic insertion of a biopsy introducer needle followed by manual acquisition of specimens using a biopsy needle. The patients were followed up for 14 days. Feasibility was defined as the distance of ≤ 10 mm between needle tip after insertion and the nearest lesion edge on the CT fluoroscopic images. The safety of robotic insertion was evaluated on the basis of machine-related troubles and adverse events according to the Clavien-Dindo classification.
Robotic insertion of the introducer needle was feasible in all patients, enabling pathological diagnosis. There was no machine-related trouble. A total of 11 adverse events occurred in 8 patients, including 10 grade I events and 1 grade IIIa event.
Insertion of biopsy introducer needles with our robot was feasible at several locations in the human body.
• Insertion of biopsy introducer needles with our robot during CT fluoroscopy–guided biopsy was feasible at several locations in the human body.
KeywordsRobotics Image-guided biopsy Biopsy Needle
Degrees of freedom
This study has received funding from the Japan Society for the Promotion of Science (JSPS) (18K07677), Promotion of Science and Technology, Okayama Prefecture, Japan, Agency for Medical Research and Development (AMED) (15hk0102014h001, 15hk0102014h002, 15hk0102014h003), JSPS (25461882, 17K10439), Organization for Research Promotion & Collaboration, Okayama University; Japan Radiological Society, and Cannon Medical Systems Corporation.
Compliance with ethical standards
The scientific guarantor of this publication is Takao Hiraki.
Conflict of interest
Drs. Hiraki and Kanazawa declare relationships with the following company: Cannon Medical Systems. Other authors of this manuscript declare no relationships with any companies, whose products or services may be related to the subject matter of the article.
Statistics and biometry
No complex statistical methods were necessary for this paper.
Written informed consent was obtained from all subjects (patients) in this study.
Institutional Review Board approval was obtained.
• performed at one institution
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