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

Area of Science:

• Surgical Oncology
• Pathology
• Medical Devices

Background:

• Accurate orientation of resected breast specimens is critical for pathological evaluation and margin assessment.
• Misorientation can compromise analysis, lead to imprecise re-excisions, and increase local recurrence risk.
• Traditional suture marking methods may not consistently ensure proper specimen orientation.

Purpose of the Study:

• To evaluate a novel specimen plate designed for consistent tissue orientation.
• To compare the effectiveness of the new specimen plate against traditional suture marking.
• To assess the impact on orientation accuracy, margin evaluation, and re-excision rates.

Main Methods:

• A single-center, prospective, randomized two-arm trial.
• 56 specimens oriented with the new plate, 54 with conventional sutures.
• Outcomes assessed included intraoperative imaging interpretation, specimen handling, and pathological assessment.

Main Results:

• The specimen plate significantly reduced misorientation (p < 0.01).
• Improved intraoperative imaging interpretation and easier identification of tumor-free zones by pathologists.
• Reduced non-R0 resections requiring re-excision (8.9% with plate vs. 22.2% with sutures).

Conclusions:

• The novel specimen plate offers a reliable solution for improving breast cancer specimen orientation.
• Enhanced orientation may reduce re-excisions and improve patient safety.
• Further multicenter validation is needed to confirm applicability across diverse surgical settings.