Histolog®扫描仪（SamanTree Medical SA，瑞士洛桑）是一种大视野共焦激光扫描显微镜，旨在通过制作组织学图像，以便在手术室对切缘进行评估。我们评估了Histolog®扫描仪（HS）在乳腺保留手术标本的临床实践中正确识别浸润边缘的可行性和性能。我们推断，如果利用HS有潜力减少浸润边缘，因此可以减少由于主要诊断为乳腺癌（包括导管内乳头状癌）而接受乳腺保留手术（BCS）的患者重新手术的比率。这是一项单中心、前瞻性、非干预性、诊断性试验，包括50名连续接受BCS的患者。手术过程和标本的术中切缘评估按照常规进行，包括传统标本放射学检查以及外科医生的临床印象。三名外科医生和一名经验丰富的病理学家评估了HS产生的扫描结果上的癌细胞。与仅有传统标本放射学检查及临床常规相比，HS正确识别涉及的边缘的潜力进行了比较。组织病理学报告作为金标准。50个与300个表面相对应的标本通过HS进行了扫描。外科医生识别涉及边缘的平均灵敏度为37.5% ± 5.6%，特异性为75.2% ± 13.0%。病理学家的切缘切除评估结果为灵敏度37.5%，特异性81.0%；而局部临床常规结果为灵敏度37.5%，特异性78.2%。在临床实践中，使用HS获取高分辨率的组织学图像是可行的。灵敏度和特异性与临床常规相当。通过更精细的培训和经验，对图像解释和获取进行更精准的评估，HS可能有潜力提高BCS标本的切缘评估准确性。版权所有© 2023作者。由Elsevier Ltd.发表，保留所有权利。

The Histolog® Scanner (SamanTree Medical SA, Lausanne, Switzerland) is a large field-of-view confocal laser scanning microscope designed to allow intraoperative margin assessment by the production of histological images ready for assessment in the operating room. We evaluated the feasibility and the performance of the Histolog® Scanner (HS) to correctly identify infiltrated margins in clinical practice of lumpectomy specimens. It was extrapolated if the utilization of the HS has the potential to reduce infiltrated margins and therefore reduce re-operation rates in patients undergoing breast conserving surgery (BCS) due to a primarily diagnosed breast cancer including ductal carcinoma in situ.This is a single-center, prospective, non-interventional, diagnostic pilot study including 50 consecutive patients receiving BCS. The complete surface of the specimen was scanned using the HS intraoperatively. The surgery and the intraoperative margin assessment of the specimen was performed according to the clinical routine consisting of conventional specimen radiography as well as the clinical impression of the surgeon. Three surgeons and an experienced pathologist assessed the scans produced by the HS for cancer cells on the surface. The potential of the HS to correctly identify involved margins was compared to the results of the conventional specimen radiography alone as well as the clinical routine. The histopathological report served as the gold standard.50 specimens corresponding to 300 surfaces were scanned by the HS. The mean sensitivity of the surgeons to identify involved margins with the HS was 37.5% ± 5.6%, the specificity was 75.2% ± 13.0%. The assessment of resection margins by the pathologist resulted in a sensitivity of 37.5% and a specificity of 81.0%, while the local clinical routine resulted in a sensitivity of 37.5% and a specificity of 78.2%.Acquisition of high-resolution histological images using the HS was feasible in clinical practice. Sensitivity and specificity were comparable to clinical routine. With more specific training and experience on image interpretation and acquisition, the HS may have the potential to enable more accuracy in the margin assessment of BCS specimens.Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.