Takao Hiraki, Yusuke Matsui, Jun Sakurai, Koji Tomita, Mayu Uka, Soichiro Kajita, Noriyuki Umakoshi, Toshihiro Iguchi, Michihiro Yoshida, Kota Sakamoto, Takayuki Matsuno, Tetsushi Kamegawa
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The robot used (Zerobot; Medicalnet Okayama) is not yet commercially available. A biopsy introducer needle was inserted by 1 of 3 physicians using a remote-control robot in the robotic group, versus by 1 of 3 different physicians by hand in the manual group. The primary endpoint was needle insertion accuracy, which was defined as the 3-dimensional Euclidean distance between a predetermined target point and the needle tip after insertion. The non-inferiority of robotic insertion to manual one was then tested. Adverse events were evaluated. Statistical comparisons were made between the 2 groups.</p><p><strong>Results: </strong>Technical success and pathological findings were confirmed in all patients of the 2 groups. The mean and SD of needle insertion were 4.8 mm ± 2.6 in the robotic group and 7.0 mm ± 3.1 in the manual group (<i>P</i> < .001). The mean difference in accuracy between the 2 groups (robotic minus manual group) was -2.1 mm (95% CI, -4.7 to 0.4). 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引用次数: 0
摘要
背景：CT引导下的机器人插针已经发展起来，但与人工插针比较的数据仍然缺乏。目的：比较CT透视引导下的介入手术中机器人与人工插针的精确性。材料和方法：这是一项于2020年5月至2023年3月在单个地点进行的前瞻性研究。该队列包括22名接受CT （Aquilion One或Aquilion CX； Canon Medical Systems）透视引导活检的患者，他们被随机分配到机器人组或手动组。所使用的机器人（Zerobot; Medicalnet Okayama）尚未商业化。在机器人组中，三名医生中有一名使用遥控机器人插入活检针，而在人工组中，三名不同的医生中有一名用手插入活检针。主要终点是针头插入精度，其定义为针头插入后预定目标点与针尖之间的三维欧氏距离。然后测试了机器人插入与人工插入的非劣性。评估不良事件。两组间进行统计学比较。结果：两组患者均获得技术成功，病理检查结果均得到证实。机器人组插针的平均值为4.8 mm±2.6，手动组为7.0 mm±3.1 （P P P = 0.100）。未观察到重大不良事件。结论：机器人插针的准确性不低于人工插针，同时有效地消除了对医生的辐射暴露。试验注册号：jRCT2062200013。
Comparison of robotic versus manual needle insertion for CT-guided intervention: prospective randomized trial.
Background: Robotic needle insertion under CT guidance has been developed, but data on comparison with manual insertion are still lacking.
Purpose: To compare robotic versus manual needle insertion for CT fluoroscopy-guided intervention, primarily in terms of insertion accuracy.
Materials and methods: This was a prospective study between May 2020 and March 2023 at a single site. The cohort comprised 22 patients undergoing CT (Aquilion One or Aquilion CX; Canon Medical Systems) fluoroscopy-guided biopsy, who were randomly allocated to either the robotic or manual group. The robot used (Zerobot; Medicalnet Okayama) is not yet commercially available. A biopsy introducer needle was inserted by 1 of 3 physicians using a remote-control robot in the robotic group, versus by 1 of 3 different physicians by hand in the manual group. The primary endpoint was needle insertion accuracy, which was defined as the 3-dimensional Euclidean distance between a predetermined target point and the needle tip after insertion. The non-inferiority of robotic insertion to manual one was then tested. Adverse events were evaluated. Statistical comparisons were made between the 2 groups.
Results: Technical success and pathological findings were confirmed in all patients of the 2 groups. The mean and SD of needle insertion were 4.8 mm ± 2.6 in the robotic group and 7.0 mm ± 3.1 in the manual group (P < .001). The mean difference in accuracy between the 2 groups (robotic minus manual group) was -2.1 mm (95% CI, -4.7 to 0.4). Effective dose to physicians was zero in all cases in the robotic group, while median dose was 1.0 µSv in the manual group (P < .001). Dose length product to patients was not significantly different between the 2 groups (P = .100). No major adverse events were observed.
Conclusion: Robotic needle insertion was non-inferior to manual insertion in terms of accuracy, while it effectively eliminated radiation exposure to physicians.
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