Breast Cancer Surgical Specimens: A Marking Challenge and a Novel Solution-A Prospective, Randomized Study

Background: Accurate orientation of resected breast specimens is essential for proper pathological evaluation and margin assessment. Misorientation may compromise analysis, lead to imprecise re-excisions, and increase the risk of local recurrence. This study aims to evaluate a novel specimen plate designed to maintain consistent tissue orientation and compares its effectiveness to traditional suture marking. Methods: In a single-center, prospective, randomized two-arm trial, 56 specimens were oriented with the new plate and 54 with conventional sutures. Outcomes included intraoperative imaging interpretation, specimen handling, and pathological assessment, with a focus on orientation accuracy and margin evaluation. Results: The specimen plate significantly reduced misorientation (p < 0.01) and improved interpretation during intraoperative imaging. Pathologists reported greater ease in identifying direction and tumor-free zones, leading to a more accurate margin assessment. Non-R0 resections requiring re-excision were fewer with the specimen plate (8.9%) compared to suture marking (22.2%). Conclusions: The newly developed specimen plate can offer a reliable solution for improving specimen orientation in breast cancer surgery; however, further validation in multicenter studies is needed to confirm its applicability across diverse surgical settings. By ensuring consistent orientation and enhancing diagnostic interpretation, it may help reduce re-excisions and improve patient safety.