生物阻抗谱技术在乳腺癌保乳手术中对切缘组织快速定性的有效性

Clinical Trial of Intraoperative Tissue Identification for Breast-Conserving Surgery Using Bio-impedance Spectroscopy

目的评价生物阻抗谱(bio-impedance spectroscopy,BIS)技术在乳腺癌保乳手术(breast-conserving surgery,BCS)过程中对切缘肿瘤细胞是否残留进行快速定性的有效性。方法采用多中心、平行试验设计,收集150份标本,对同一份被测切缘样本按顺序先后使用BIS、冰冻切片活检和石蜡切片活检进行检测,在该标本的3项检测结果全部得到以后,将BIS的检测结果与冰冻切片活检的检查结果作一致性比较;将石蜡切片活检的检测结果作为金标准,评估BIS检测的灵敏度和特异度。比较三种方法的检测用时。结果BIS检测的灵敏度为92.98%,特异度为94.62%,与冰冻切片活检的一致性较高,Kappa值大于0.75。BIS检测时间均值为2.63min,短于冰冻切片活检(18.97min)和石蜡切片用时(1.12d)。结论利用BIS技术对乳腺癌保乳手术中的切缘样本是否含有癌变组织的定性检测具有较高准确性,适用于术中的快速判断。

Objective To evaluate the effectiveness of bio-impedance spectroscopy（BIS）analysis for marginal tissue malignancy/benignancy identification during Breast-Conserving Surgery（BCS）.Methods A multicenter parallel-group clinical trial was conducted with the patients who received breast conserving surgery in 2hospitals.One hundred and fifty breast tissue specimens were collected and analyzed by BIS,frozen section biopsy and paraffin section biopsy respectively.Results were compared and statistical analysis was implemented.Results For BIS technique to identify malignant/benign marginal tissues,the sensitivity was 92.98%,and the specificity was94.62%.The coherence of BIS results and frozen section biopsy results was significant,and the Kappa value was higher than 0.75.The mean measuring time of BIS was 2.63 min,which was shorter than frozen section biopsy（18.97 min）and paraffin section biospy（1.12d）.Conclusion BIS technique likely has high accuracy in tissue identification so has potential to be adopted as a real-time indicator for marginal tissue malignancy/benignancy identification during breast-conserving surgery.