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European Radiology

, Volume 30, Issue 2, pp 927–933 | Cite as

Robotic needle insertion during computed tomography fluoroscopy–guided biopsy: prospective first-in-human feasibility trial

  • Takao HirakiEmail author
  • Tetsushi Kamegawa
  • Takayuki Matsuno
  • Jun Sakurai
  • Toshiyuki Komaki
  • Takuya Yamaguchi
  • Koji Tomita
  • Mayu Uka
  • Yusuke Matsui
  • Toshihiro Iguchi
  • Hideo Gobara
  • Susumu Kanazawa
Interventional

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

Robotics Image-guided biopsy Biopsy Needle 

Abbreviations

CT

Computed tomography

DOF

Degrees of freedom

SD

Standard deviation

Notes

Funding

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

Guarantor

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.

Informed consent

Written informed consent was obtained from all subjects (patients) in this study.

Ethical approval

Institutional Review Board approval was obtained.

Methodology

• prospective

• observational

• performed at one institution

Supplementary material

330_2019_6409_MOESM1_ESM.docx (22 kb)
ESM 1 (DOCX 21 kb)

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Copyright information

© European Society of Radiology 2019

Authors and Affiliations

  • Takao Hiraki
    • 1
    Email author
  • Tetsushi Kamegawa
    • 2
  • Takayuki Matsuno
    • 3
  • Jun Sakurai
    • 4
  • Toshiyuki Komaki
    • 1
  • Takuya Yamaguchi
    • 5
  • Koji Tomita
    • 1
  • Mayu Uka
    • 1
  • Yusuke Matsui
    • 1
  • Toshihiro Iguchi
    • 1
  • Hideo Gobara
    • 6
  • Susumu Kanazawa
    • 1
  1. 1.Department of RadiologyOkayama University Medical SchoolOkayamaJapan
  2. 2.Graduate School of Interdisciplinary Science and Engineering in Health SystemsOkayama UniversityOkayamaJapan
  3. 3.Graduate School of Natural Science and TechnologyOkayama UniversityOkayamaJapan
  4. 4.Center for Innovative Clinical MedicineOkayama University HospitalOkayamaJapan
  5. 5.Division of Radiology, Medical Technology DepartmentOkayama University HospitalOkayamaJapan
  6. 6.Division of Medical InformaticsOkayama University HospitalOkayamaJapan

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