A Novel Fluorescent Ductal Needle With Controllable Detachment for Real-time Localization and Sampling of High-risk Breast Micro Lesions: a Retrospective Study

The diameter of breast ducts is less than 0.7 mm, which poses a considerable technical challenge in the accurate localization of early-stage small lesions during surgical and pathological sampling. These early micro lesions typically measure on the millimeter scale, necessitating an increased excision margin by surgeons to reduce the risk of overlooking them. However, this practice complicates the pathologists' ability to accurately identify these micro lesions during diagnosis, thereby heightening the likelihood of missed diagnoses and the potential for additional surgeries for patients. Current localization methods, such as liquid methylene blue and traditional localization needles, demonstrate a high rate of pathological missed diagnoses due to inaccuracies in localization and specimen contamination. Therefore, there is an urgent need for the development of innovative localization technologies that can facilitate the precise identification of millimeter-scale micro lesions within breast ducts and improve the accuracy of pathological sampling. This study aims to conduct a retrospective analysis to compare the consistency of intraoperative and postoperative pathological assessments between a novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating, and conventional localization techniques used during breast duct lesion surgeries. The objective is to evaluate the clinical utility of the new fluorescent localization needle in the accurate pathological diagnosis of micro lesions within breast ducts and to enhance the precision of pathological assessments.