Lux Michael P, Schuller Zlatna, Heimann Sara, Reichert Verena M C, Kersting Christian, Buerger Horst, Sandor Mariana-Felicia
Department of Gynecology and Obstetrics, Women's Hospital St. Louise, Paderborn, St. Vincenz-Krankenhaus, Husener Str. 81, 33098 Paderborn, Germany.
Institute of Pathology, Husener Strasse 46 c, 33098 Paderborn, Germany.
Cancers (Basel). 2025 May 12;17(10):1640. doi: 10.3390/cancers17101640.
: 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. : 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. : 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 ( > 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 ( = 0.016). Notably, 17/21 positive margins were intraoperatively identified with the HLS while 4/21 were detected with standard-of-care techniques. : 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.
在保乳手术（BCS）中，15%至40%的患者因术后切缘癌阳性必须接受二次手术（再次手术）。术中对肿块切除切缘进行有效评估可降低这一比例。像标本射线照相和超声等传统方法存在局限性。开展SHIELD研究是为了前瞻性地量化当外科医生在术中使用组织学扫描仪（HLS）共聚焦显微镜进行切缘评估时再次手术率的降低情况。：招募并分析了50例行BCS的患者。除了标准护理技术外，外科医生在术中使用HLS对肿块切除切缘进行评估。检测到的阳性切缘会在同一手术中引发额外切除。随后分别将再次手术率和检测率与历史数据及病理金标准进行比较。：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（DCIS）患者以及50%的浸润性癌与DCIS混合的患者。总体平均年龄为63.56岁。所有人群特征在统计学上与历史对照相似（>0.1）。值得注意的是，外科医生使用HLS在术中实现了切缘乳腺癌检测的80.95%敏感性和99.53%特异性。SHIELD研究中的再次手术率为10%（5/50），而历史对照为30%（12/40），相应降低了67%（P = 0.016）。值得注意的是，21例阳性切缘中有17例在术中通过HLS识别，而21例中有4例通过标准护理技术检测到。：术中使用组织学扫描仪共聚焦显微镜可显著提高肿块切除阳性切缘的检测率，从而大幅降低再次手术率，同时保持标本完整性且不影响组织病理学评估。
