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多中心、前瞻性、观察性研究一种新型术前肺结节定位技术。

Multicenter, prospective, observational study of a novel technique for preoperative pulmonary nodule localization.

机构信息

Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China; Department of Thoracic Surgery, Huadong Hospital Affiliated to FuDan University, Shanghai, China.

Department of General Thoracic Surgery, Department of BioMedical Research, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Graduate School for Cellular and Biomedical Sciences, University of Bern, Bern, Switzerland.

出版信息

J Thorac Cardiovasc Surg. 2020 Aug;160(2):532-539.e2. doi: 10.1016/j.jtcvs.2019.10.148. Epub 2019 Nov 14.

Abstract

OBJECTIVES

Minimally invasive surgery provides an ideal method for pathologic diagnosis and curative intent of small pulmonary nodules (SPNs); however, the main problem with thoracoscopic resection is the difficulty in locating the nodules. The goal of this study was to determine the safety and feasibility of a new localization technique tailored for SPNs.

METHODS

A computed tomography (CT)-guided technique, which has a tri-colored suture and claw with 4 fishhook-shaped hooks, was designed to localize SPN preoperatively. Then a multicenter, prospective study was conducted to evaluate the safety and feasibility of this device. The primary endpoints included safety (asymptomatic/symptomatic pneumothorax or parenchymal hemorrhage, and unanticipated adverse effects) and success rate (precise placement and device fracture, displacement, or dislodgement). The secondary endpoints included feasibility (duration of the localization procedure and device fracture or fault) and patient comfort (pain).

RESULTS

A total of 90 SPNs were localized from 80 patients. Overall, no symptomatic complications requiring medical intervention, with the exception of asymptomatic pneumothorax (n = 7 [7.8%]) and lung hemorrhages (n = 5 [5.6%]), were observed. The device was successfully placed without dislodgment or movement in 87 of 90 lesions (96.7%). The median nodule size was 0.70 cm (range, 0.30-1.0 cm). The median duration of the procedure was 15 minutes (range, 7-36 minutes). No patient complained of notable pain during or after the procedure.

CONCLUSIONS

This new device for SPNs is safe, and has a high success rate, feasibility and good tolerance.

摘要

目的

微创外科为肺部小结节(SPN)的病理诊断和治疗目的提供了理想的方法;然而,胸腔镜切除的主要问题是结节定位困难。本研究旨在确定一种新的 SPN 定位技术的安全性和可行性。

方法

设计了一种 CT 引导的技术,该技术带有三色缝线和带有 4 个鱼钩状钩子的爪子,用于术前定位 SPN。然后进行了一项多中心、前瞻性研究,以评估该设备的安全性和可行性。主要终点包括安全性(无症状/症状性气胸或实质出血,以及意外不良事件)和成功率(准确定位和器械断裂、移位或脱落)。次要终点包括可行性(定位程序的持续时间和器械断裂或故障)和患者舒适度(疼痛)。

结果

共对 80 例患者的 90 个 SPN 进行了定位。总体而言,除无症状性气胸(n=7[7.8%])和肺出血(n=5[5.6%])外,未观察到需要医疗干预的症状性并发症。90 个病变中有 87 个(96.7%)成功放置了器械,无移位或移动。结节大小中位数为 0.70cm(范围,0.30-1.0cm)。手术中位数时间为 15 分钟(范围,7-36 分钟)。没有患者在手术过程中和手术后抱怨明显疼痛。

结论

这种新的 SPN 定位装置安全、成功率高、可行性好、耐受性好。

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