Evaluation of the accuracy of EndoSCellTM system in margin assessment for breast-conserving surgery.

Background: The rapid and accurate assessment of surgical margins in breast-conserving surgery (BCS) remains a pressing clinical challenge. This study aims to evaluate the effectiveness of the EndoSCellTM system, an innovative intraoperative cellular probing technology in assessing surgical margins during BCS and distinguishing between cancerous and normal breast tissue, to explore the feasibility of evaluating surgical margins during BCS.

Methods: Patients diagnosed with primary breast cancer by core needle biopsy and received BCS were consecutively enrolled from August 2022 to March 2023. Tissue samples from the primary lesion, peritumoral tissue, and normal breast tissue were obtained from consecutive cases undergoing BCS. A junior surgeon and a senior surgeon employed the EndoSCellTM system during routine breast-conserving or oncoplastic breast-conserving surgeries. Three pathologists were included to assess the accuracy of surgical margin determinations using the EndoSCellTM system postoperatively. The paraffin-embedded pathology remains the gold standard for diagnosis.

Results: A total of 53 breast cancer patients, including 43 (81.1%) cases of invasive carcinoma and 10 cases (18.9%) of ductal carcinoma in situ (DCIS) were enrolled in this study, with a total of 289 biopsy samples collected. Using the EndoSCellTM system, surgical oncologists achieved an area under the curve (AUC) of 0.909, demonstrating a sensitivity of 88.70% and a specificity of 93.01%. Pathologists, on the other hand, achieved a higher AUC of 0.937, with a sensitivity of 99.32% and a specificity of 88.11%. In the evaluation of diagnostic consistency using the EndoSCellTM system, the AUC for the comparison between pathologists and surgical oncologists was 0.880.

Conclusions: The application of the EndoSCellTM system has proven effective in assessing the pathological state of tissues in real-time, offering a feasible method for evaluating surgical margins during BCS. This technology not only supports the decision-making process in surgery but also provides a foundation for further prospective clinical validation.