Introduction: In breast conserving surgery (BCS), 15–40% of patients must undergo a second surgery (re-operation) due to post-surgical cancer-positive margins. Efficient intraoperative assessment of lumpectomy margins can reduce this rate. Classical methods like specimen radiography and ultrasound have limitations. The SHIELD study was conducted to prospectively quantify the reduction of the re-operation rate when the Histolog®Scanner (HLS) confocal microscope is intraoperatively used by surgeons for the margin assessment.Methods: 50 patients undergoing BCS were enrolled and analyzed. Lumpectomy margins were intraoperatively assessed by surgeons with the HLS in addition to standard-of-care techniques. Detected positive margins triggered the excision of additional recuts during the same surgery. Subsequent re-operation and detection rates were compared to historical data and pathology gold standards, respectively.Results: The study population included 32% of patients with pure invasive cancer(s), 18% with pure DCIS and 50% with invasive cancer(s) mixed with DCIS. The overall mean age was 63.56. All population features were statistically similar to the historical control (p> 0.1). Notably, 80.95% sensitivity and 99.53% specificity for breast cancer detection at the margin were intraoperatively achieved by the surgeons using the HLS. The re-operation rate in SHIELD was 10% (5/50) while the historical control was 30% (12/40) corresponding to a 67% reduction (p= 0.016). Notably, 17/21 positive margins were intraoperatively identified with the HLS while 4/21 were detected with standard-of-care techniques.Conclusions: The intraoperative use of the Histolog Scanner confocal microscope provides a significant increase in detection rates of lumpectomy positive margins resulting in a substantial reduction in the re-operation rate, while preserving specimen integrity without impact on histopathology assessment.
引言：在保乳手术中，15-40%的患者因术后切缘阳性需接受二次手术。有效的术中切缘评估可降低这一比例。传统方法如标本X线摄影和超声存在局限性。SHIELD研究旨在前瞻性量化外科医生术中使用Histolog®Scanner共聚焦显微镜进行切缘评估对二次手术率的降低效果。 方法：研究纳入并分析了50例接受保乳手术的患者。除标准诊疗技术外，外科医生术中使用Histolog®Scanner对肿块切除切缘进行评估。检测到的阳性切缘在同一手术中触发补充切除。随后将二次手术率和检出率分别与历史数据及病理学金标准进行比较。 结果：研究人群包括32%的单纯浸润性癌患者、18%的单纯导管原位癌患者及50%的浸润性癌合并导管原位癌患者。总体平均年龄为63.56岁。所有人群特征与历史对照组无统计学差异（p>0.1）。值得注意的是，外科医生使用Histolog®Scanner在术中实现了80.95%的乳腺癌切缘检测敏感性和99.53%的特异性。SHIELD研究的二次手术率为10%（5/50），而历史对照组为30%（12/40），相当于降低67%（p=0.016）。特别需要指出的是，21个阳性切缘中有17个通过Histolog®Scanner在术中被识别，而4/21通过标准诊疗技术检测到。 结论：术中使用Histolog Scanner共聚焦显微镜可显著提高肿块切除阳性切缘的检出率，从而大幅降低二次手术率，同时在不影响组织病理学评估的前提下保持标本完整性。
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