Abstract

Introduction: 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. Results: 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. Conclusion: Insertion of biopsy introducer needles with our robot was feasible at several locations in the human body. Key Points: • Insertion of biopsy introducer needles with our robot during CT fluoroscopy–guided biopsy was feasible at several locations in the human body.

Original languageEnglish
JournalEuropean Radiology
DOIs
Publication statusAccepted/In press - Jan 1 2019

Fingerprint

Robotics
Needle Biopsy
Needles
Tomography
Biopsy
Human Body
Safety
Mediastinum
Adrenal Glands
Extremities
Kidney
Muscles
Lung

Keywords

  • Biopsy
  • Image-guided biopsy
  • Needle
  • Robotics

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

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title = "Robotic needle insertion during computed tomography fluoroscopy–guided biopsy: prospective first-in-human feasibility trial",
abstract = "Introduction: 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. Results: 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. Conclusion: Insertion of biopsy introducer needles with our robot was feasible at several locations in the human body. Key Points: • Insertion of biopsy introducer needles with our robot during CT fluoroscopy–guided biopsy was feasible at several locations in the human body.",
keywords = "Biopsy, Image-guided biopsy, Needle, Robotics",
author = "Takao Hiraki and Tetsushi Kamegawa and Takayuki Matsuno and Jun Sakurai and Toshiyuki Komaki and Takuya Yamaguchi and Koji Tomita and Mayu Uka and Yusuke Matsui and Toshihiro Iguchi and Hideo Gobara and Susumu Kanazawa",
year = "2019",
month = "1",
day = "1",
doi = "10.1007/s00330-019-06409-z",
language = "English",
journal = "European Radiology",
issn = "0938-7994",
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TY - JOUR

T1 - Robotic needle insertion during computed tomography fluoroscopy–guided biopsy

T2 - prospective first-in-human feasibility trial

AU - Hiraki, Takao

AU - Kamegawa, Tetsushi

AU - Matsuno, Takayuki

AU - Sakurai, Jun

AU - Komaki, Toshiyuki

AU - Yamaguchi, Takuya

AU - Tomita, Koji

AU - Uka, Mayu

AU - Matsui, Yusuke

AU - Iguchi, Toshihiro

AU - Gobara, Hideo

AU - Kanazawa, Susumu

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Introduction: 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. Results: 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. Conclusion: Insertion of biopsy introducer needles with our robot was feasible at several locations in the human body. Key Points: • Insertion of biopsy introducer needles with our robot during CT fluoroscopy–guided biopsy was feasible at several locations in the human body.

AB - Introduction: 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. Results: 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. Conclusion: Insertion of biopsy introducer needles with our robot was feasible at several locations in the human body. Key Points: • Insertion of biopsy introducer needles with our robot during CT fluoroscopy–guided biopsy was feasible at several locations in the human body.

KW - Biopsy

KW - Image-guided biopsy

KW - Needle

KW - Robotics

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U2 - 10.1007/s00330-019-06409-z

DO - 10.1007/s00330-019-06409-z

M3 - Article

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JO - European Radiology

JF - European Radiology

SN - 0938-7994

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