Department of Radiology, Okayama University Medical School, 2-5-1 Shikatacho, Kitaku, Okayama, 700-8558, Japan.
Graduate School of Interdisciplinary Science and Engineering in Health Systems, Okayama University, 3-1-1 Tsushimanaka, Kitaku, Okayama, 700-8530, Japan.
Eur Radiol. 2020 Feb;30(2):927-933. doi: 10.1007/s00330-019-06409-z. Epub 2019 Aug 23.
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.
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.
这是一项前瞻性、首例人体试验，旨在评估在 CT 透视引导下活检中使用我们的机器人插入活检引入针的可行性和安全性。
符合条件的患者为需要 CT 透视引导下活检进行病理诊断的四肢或躯干部位直径≥10mm 的病变患者。如果危险结构距离预定针道 10mm 以内，则排除患者。10 例患者（4 名女性和 6 名男性；平均[范围]年龄 72[52-87]岁）患有肾脏（n=4）、肺（n=3）、纵隔（n=1）、肾上腺（n=1）和肌肉（n=1）病变，病变（平均[范围]最大直径 28[14-52]mm）。活检程序包括机器人插入活检引入针，然后使用活检针手动采集标本。对患者进行 14 天随访。可行性定义为插入后针尖与 CT 透视图像上最近病变边缘之间的距离≤10mm。根据 Clavien-Dindo 分类，根据与机器相关的故障和不良事件评估机器人插入的安全性。
所有患者均可行机器人插入引入针，从而能够进行病理诊断。没有与机器相关的故障。8 例患者共发生 11 例不良事件，包括 10 例 I 级事件和 1 例 IIIa 级事件。
在人体的几个部位，使用我们的机器人插入活检引入针是可行的。
• 在 CT 透视引导下活检中使用我们的机器人插入活检引入针在人体的几个部位是可行的。
