Department of Surgical Oncology, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium.
Department of Surgical Oncology, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium; Clinical Trials Unit, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium.
Eur J Surg Oncol. 2021 Feb;47(2):269-275. doi: 10.1016/j.ejso.2020.09.036. Epub 2020 Oct 13.
Positive margins after breast-conserving surgery (BCS) for breast cancer (BC) remain a major concern. In this study we investigate the feasibility and accuracy of indocyanine green (ICG) fluorescence imaging (FI) for the in vivo assessment of surgical margins during BCS.
Patients with BC admitted for BCS from October 2015 to April 2016 were proposed to be included in the present study (NCT02027818). ICG (0.25 mg/kg) was intravenously injected at induction anesthesia and ICG-FI of the surgical beds was correlated with final pathology results.
Fifty patients consented to participate and thirty-five patients were retained for final analysis, 15 patients having been excluded for, respectively, incomplete video records data for signal to background ratio (SBR) calculation (11) and in situ tumors (4). The final pathological assessment of 35 breast specimens identified 5 (14.7%) positive margins. Intraoperative ICG-FI revealed hyperfluorescent signals in 15 (42.9%) patients and an absence of fluorescent signals in 20 (57.1%). Median SBR in patients with involved margins was 1.8 (SD 0.7) and was 1.25 (SD 0.6) in patients with clear margins (p = 0.05). The accuracy, specificity, positive and negative predictive value of ICG-FI for breast surgical margin assessment were 71%, 60%, 29% and 100%, respectively.
ICG-FI of BC surgical beds has a high negative predictive value for surgical margin assessment during BCS. The absence of residual fluorescence in the surgical bed of patients with fluorescent tumors predicts negative margins at final pathology and allows the surgeon to avoid further intraoperative analysis.
乳腺癌(BC)保乳手术后(BCS)的阳性切缘仍然是一个主要关注点。本研究旨在探讨吲哚菁绿(ICG)荧光成像(FI)在BCS 术中评估手术切缘的可行性和准确性。
2015 年 10 月至 2016 年 4 月期间,因 BCS 入院的 BC 患者被提议纳入本研究(NCT02027818)。在诱导麻醉时静脉注射 0.25mg/kg 的 ICG,并将手术床的 ICG-FI 与最终病理结果相关联。
50 例患者同意参与研究,35 例患者保留进行最终分析,15 例患者因分别存在信号与背景比(SBR)计算的视频记录数据不完整(11 例)和原位肿瘤(4 例)而被排除。35 例乳腺标本的最终病理评估发现 5 例(14.7%)阳性切缘。术中 ICG-FI 显示 15 例(42.9%)患者出现荧光信号增强,20 例(57.1%)患者无荧光信号。阳性切缘患者的中位 SBR 为 1.8(SD 0.7),阴性切缘患者的中位 SBR 为 1.25(SD 0.6)(p=0.05)。ICG-FI 评估乳腺手术切缘的准确性、特异性、阳性预测值和阴性预测值分别为 71%、60%、29%和 100%。
BCS 术中 BC 手术床的 ICG-FI 对手术切缘评估具有较高的阴性预测值。荧光肿瘤患者手术床无残留荧光预示着最终病理的阴性切缘,并允许外科医生避免进一步的术中分析。