A prospective comparison of a modified miniaturised hand‐held epifluorescence microscope and touch imprint cytology for evaluation of axillary sentinel lymph nodes intraoperatively in breast cancer patients

Abstract Background The management of axillary lymph nodes in early‐stage breast cancer patients has changed considerably, with the primary focus shifting from the examination of sentinel lymph nodes (SLNs) to toward the detection of all macro‐metastases. However, current methods, such as touch imprint cytology (TIC) and frozen sections, are inadequate for clinical needs. To address this issue, we proposed a novel miniaturised epifluorescence widefield microscope (MEW‐M) to assess SLN status intraoperatively for improved diagnostic efficiency. Methods A prospective, side‐by‐side comparison of intraoperative SLN evaluation between MEW‐M and TIC was performed. Results A total of 73 patients with 319 SLNs consecutive enrolled in this study. MEW‐M showed significantly superior image quality compared to TIC (median score 3.1 vs 2.1, p < 0.0001) and had a shorter time to issue results (10.3 vs 19.4 min, p < 0.0001). Likelihood ratio analysis illustrated that the positive likelihood ratio value of MEW‐M compared with TIC was infinitely great vs 52.37 (95% CI, 21.96‐124.90) in model 1 (classifying results into negative/positive), infinitely great vs 52.37 (95% CI, 21.96‐124.90) in model 2 (classifying results into macro‐metastasis/others, and TIC results followed the same classification as model 1), respectively. Similarly, the negative likelihood ratio values of MEW‐M compared with TIC were 0.055 (95% CI, 0.018‐0.160) and 0.074 (95% CI, 0.029‐0.190) in model 1; and 0.019 (95% CI, 0.003‐0.130) vs 0.020 (95% CI, 0.003‐0.140) in model 2, respectively. Conclusions MEW‐M is a promising technique that can be utilised to provide a rapid and accurate intraoperative assessment of SLN in a clinical setting to help improve decision‐making in axillary surgery.