Safety and Efficacy Clinical Trial of Robot-Assisted Prostate Biopsy Using a Hand-Held Robotic System

IF 2.1 3区医学 Q2 SURGERY International Journal of Medical Robotics and Computer Assisted Surgery Pub Date : 2025-03-10 DOI:10.1002/rcs.70062

Wenhe Jiang, Yongzhuo Gao, Mingwei Wen, Qiangqiang Huang, Hui Dong, Huageng Liang, Dongmei Wu, Wei Dong

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Abstract

Background

Robotic systems are increasingly utilised to improve clinical outcomes in prostate interventions.

Methods

We enroled 20 patients to verify the clinical feasibility of transrectal ultrasound (TRUS)-guided robot-assisted prostate biopsy (PBx). For each patient, controlled trials of systematic 12-core PBx were initially conducted manually using a biopsy gun, followed by a 3-core cognitive fusion targeted biopsy performed by the hand-held robot.

Results

The targeting errors for robot-assisted biopsy and freehand biopsy were 3.71 ± 1.41 mm and 3.94 ± 1.49 mm, respectively. Their cancer core rates were 19.1% and 12.6%, and the average duration of each biopsy was 6.94 min and 1.62 min, respectively.

Conclusions

The robot's sampling success rate was lower than that of freehand with a biopsy gun in the clinical trial. However, robot-assisted PBx has shown improved cancer core rate, slightly enhanced surgical accuracy, and the capability to reach clinically significant tumours' 5 mm error range, all demonstrating its clinical value.

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手持机器人辅助前列腺活检系统的安全性和有效性临床试验

机器人系统越来越多地用于改善前列腺干预的临床结果。方法选取20例患者，验证经直肠超声（TRUS）引导下机器人辅助前列腺活检（PBx）的临床可行性。对于每位患者，系统的12核PBx对照试验最初使用活检枪手动进行，随后由手持机器人进行3核认知融合靶向活检。结果机器人辅助活检和徒手活检的靶位误差分别为3.71±1.41 mm和3.94±1.49 mm。他们的核心癌率分别为19.1%和12.6%，每次活检的平均时间分别为6.94分钟和1.62分钟。结论在临床试验中，机器人的取样成功率低于徒手活检枪的取样成功率。然而，机器人辅助PBx已经显示出癌症核心率的提高，手术精度的略微提高，以及达到临床显著肿瘤5毫米误差范围的能力，这些都证明了它的临床价值。

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来源期刊

International Journal of Medical Robotics and Computer Assisted Surgery 医学-外科

CiteScore

4.50

自引率

12.00%

发文量

131

审稿时长

6-12 weeks

期刊介绍： The International Journal of Medical Robotics and Computer Assisted Surgery provides a cross-disciplinary platform for presenting the latest developments in robotics and computer assisted technologies for medical applications. The journal publishes cutting-edge papers and expert reviews, complemented by commentaries, correspondence and conference highlights that stimulate discussion and exchange of ideas. Areas of interest include robotic surgery aids and systems, operative planning tools, medical imaging and visualisation, simulation and navigation, virtual reality, intuitive command and control systems, haptics and sensor technologies. In addition to research and surgical planning studies, the journal welcomes papers detailing clinical trials and applications of computer-assisted workflows and robotic systems in neurosurgery, urology, paediatric, orthopaedic, craniofacial, cardiovascular, thoraco-abdominal, musculoskeletal and visceral surgery. Articles providing critical analysis of clinical trials, assessment of the benefits and risks of the application of these technologies, commenting on ease of use, or addressing surgical education and training issues are also encouraged. The journal aims to foster a community that encompasses medical practitioners, researchers, and engineers and computer scientists developing robotic systems and computational tools in academic and commercial environments, with the intention of promoting and developing these exciting areas of medical technology.