Supplementary Material for: First in Human Evaluation of a Novel Thin Convex Probe Endobronchial Ultrasound System

Introduction: The incidence of pulmonary imaging abnormalities continues to increase. While standard CP-EBUS is safe and accurate, it has limited reach through smaller bronchi. Olympus BF-Y0069 TCP-EBUS has smaller diameter and improved angulation. We assessed safety and feasibility of the TCP-EBUS to evaluate lesions not accessible with CP-EBUS.
Methods: A single-center, prospective, pilot study evaluating TCP-EBUS enrolled patients undergoing bronchoscopy for lesions within the inner two-thirds of the lung. Patients underwent CP-EBUS to attempt visualization and biopsy. If unsuccessful, TCP-EBUS was used. Safety, lesion characteristics, and pathology results were collected.
Results: 51 patients were enrolled with multiple lesion locations and no adverse safety events with TCP-EBUS. Seven cases(13.7%) were omitted as the target lesion was visualized by CP-EBUS and TCP-EBUS. CP-EBUS failed to provide biopsy for 44 cases. CP-EBUS visualized 7/44, however, was unable to biopsy. TCP-EBUS visualized 36/44(81.8 %) lesions and biopsied 27/44(61%) lesions. 8/44(15.7%) lesions could not be visualized with either device. Median lesion size biopsied with CP-EBUS was 41mm(IQR 22-48). Median size of lesions visualized with TCP-EBUS was 20mm(IQR 15.3-38), range 8-70. The median distance from the main carina was 62mm(IQR 60-89) for lesions biopsied with the CP-EBUS and 63.3(IQR 48.5-78.8) for TCP-EBUS. While average distances from main carina were similar in both groups, the furthest lesion TCP-EBUS visualized was 120mm from the carina compared to 100mm with CP-EBUS.
Conclusions: The use of TCP- EBUS was safe and effective without observed patient-associated complications, and it provided real-time ultrasonographic visualization and biopsy of lesions not accessible with CP-EBUS.

引言：肺部影像异常的发病率持续攀升。尽管标准凸面探头支气管内超声（Convex Probe Endobronchial Ultrasound，CP-EBUS）安全且精准，但其在细小支气管内的探查范围有限。奥林巴斯BF-Y0069型锥形探头支气管内超声（TCP-EBUS）直径更小且成角性能更优。本研究旨在评估TCP-EBUS用于评估CP-EBUS无法探查的肺部病灶的安全性与可行性。
方法：本研究为单中心前瞻性先导试验，纳入因肺部内三分之二区域存在病灶而接受支气管镜检查的患者。所有患者先行CP-EBUS检查以尝试对病灶进行显像与活检。若CP-EBUS操作失败，则改用TCP-EBUS。研究收集了手术安全性、病灶特征及病理结果等数据。
结果：本研究共纳入51例患者，病灶分布于多个部位，使用TCP-EBUS未出现任何不良安全事件。其中7例（13.7%）被剔除，因目标病灶可通过CP-EBUS完成显像与活检，无需使用TCP-EBUS。44例患者的CP-EBUS活检操作失败：其中7例虽经CP-EBUS成功显像，但未能完成活检。TCP-EBUS成功显像36/44（81.8%）例病灶，并完成27/44（61%）例病灶的活检。另有8/44（15.7%）例病灶无法通过两种设备完成显像。CP-EBUS活检病灶的中位直径为41mm（四分位间距22~48mm）；TCP-EBUS显像病灶的中位直径为20mm（四分位间距15.3~38mm），直径范围为8~70mm。CP-EBUS活检病灶距主气管隆突的中位距离为62mm（四分位间距60~89mm），TCP-EBUS操作病灶的该中位距离为63.3mm（四分位间距48.5~78.8mm）。尽管两组病灶距主气管隆突的平均距离相近，但TCP-EBUS可探查的最远病灶距隆突120mm，而CP-EBUS仅为100mm。
结论：TCP-EBUS的应用安全有效，未观察到任何与患者相关的并发症，且可对CP-EBUS无法探查的病灶实现实时超声显像与活检。