Yu Hao, Yao Yuhao, Zhu Tingting, Sun Yulu, Zhang Meng, Zhang Yin, Cao Meng, Zhang Weijie, Yao Yongzhong
Division of Breast Surgery, Department of General Surgery, Nanjing Drum Tower Hospital, Nanjing Drum Tower Hospital Clinical College, Nanjing Medical University, Nanjing, China.
Department of Computer Science, Westcliff University, Irvine, CA, USA.
Gland Surg. 2024 Jun 30;13(6):1031-1044. doi: 10.21037/gs-24-195. Epub 2024 Jun 27.
Fluorescence-guided surgery (FGS) is a cutting-edge technology that uses near-infrared (NIR) fluorescence imaging to guide surgeons in surgery. Indocyanine green (ICG) is a fluorescent dye, which can be used for imaging of tumor cells. We aimed to explore the use of ICG fluorescence-guided technology as a rapid intraoperative margin assessment method for breast cancer surgery. In addition, we also compared the dose selection of ICG.
This was a non-randomized prospective cohort study. Data were collected between August 2021 and October 2022 in the Division of Breast Surgery, Department of General Surgery, Nanjing Drum Tower Hospital, the Affiliated Hospital of Medical School, Nanjing University. Upon specimen removal, tumor margins were immediately analyzed by ICG fluorescence detection and then sent to the pathology department for intraoperative frozen section analysis and subsequent routine pathological examination. Abnormal margin rates were calculated and compared using intraoperative frozen section analysis and under the guidance of ICG fluorescence.
The study included 69 cases of breast cancer patients who underwent tumor resection assisted by ICG fluorescence-guided technology, including 18 patients with a 0.5 mg/kg dose and 51 patients with a 1.0 mg/kg dose. According to the study findings, the ICG test achieved a sensitivity of 81.82% and a specificity of 75.82%. At a dose of 0.5 mg/kg, the sensitivity was 66.67% whereas the specificity was 93.33%. At the dose of 1 mg/kg, the sensitivity was 87.5%, and the specificity was 74.42%. Similarly, for intraoperative frozen section analysis, the sensitivity was 81.82%, but the specificity was enhanced to 94.83%. Positive surgical cut margin was not identified in 2/69 by ICG fluorescence and frozen section analysis respectively.
The sensitivity of ICG fluorescence detection is comparable to that of frozen section analysis, but the specificity is poor. The sensitivity increased and the specificity decreased at 1 mg/kg compared to the 0.5 mg/kg dose. ICG fluorescence can be used as a supplementary tool for frozen section analysis. These findings support further development and clinical performance assessment of ICG fluorescence.
荧光引导手术（FGS）是一项前沿技术，它利用近红外（NIR）荧光成像来指导外科医生进行手术。吲哚菁绿（ICG）是一种荧光染料，可用于肿瘤细胞成像。我们旨在探索将ICG荧光引导技术用作乳腺癌手术中快速术中切缘评估方法。此外，我们还比较了ICG的剂量选择。
这是一项非随机前瞻性队列研究。2021年8月至2022年10月期间在南京大学医学院附属鼓楼医院普通外科乳腺外科收集数据。标本切除后，立即通过ICG荧光检测分析肿瘤切缘，然后送病理科进行术中冰冻切片分析及后续常规病理检查。计算异常切缘率，并使用术中冰冻切片分析和ICG荧光引导下的结果进行比较。
该研究纳入了69例接受ICG荧光引导技术辅助肿瘤切除的乳腺癌患者，其中18例使用0.5mg/kg剂量，51例使用1.0mg/kg剂量。根据研究结果，ICG检测的灵敏度为81.82%，特异性为75.82%。在0.5mg/kg剂量下，灵敏度为66.67%，而特异性为93.33%。在1mg/kg剂量下，灵敏度为87.5%，特异性为74.42%。同样，对于术中冰冻切片分析，灵敏度为81.82%，但特异性提高到94.83%。ICG荧光和冰冻切片分析分别在69例中的2例未发现手术切缘阳性。
ICG荧光检测的灵敏度与冰冻切片分析相当，但特异性较差。与0.5mg/kg剂量相比，1mg/kg剂量时灵敏度增加而特异性降低。ICG荧光可用作冰冻切片分析的辅助工具。这些发现支持ICG荧光的进一步开发和临床性能评估。
