Prospective study on the applicability of Histolog® Scanner in Oral Cavity Cancer Surgery: analysis of time, costs and margin outcomes

Background: Achieving tumor-free surgical margins is a key objective in the surgical management of oral cavity squamous cell carcinoma (OCSCC). Frozen section analysis remains the standard method for intraoperative margin assessment, but is associated with several limitations, including time consumption, costs, workflow complexity, and dependence on pathology service availability. Within this context, Histolog® Scanner has emerged as a fluorescence confocal microscopy system capable of generating rapid histology-like images of fresh tissue specimens directly in the operating room. The aim of this study was to evaluate the feasibility, diagnostic performance, and workflow efficiency of the Histolog® Scanner for intraoperative assessment of tongue resection margins in OCSCC. Methods: This was a prospective single-center pilot diagnostic accuracy and workflow study conducted at the University Hospital of Modena between October 2025 and April 2026. Twelve consecutive patients undergoing surgery for OCSCC were included. A total of 95 tongue margins were analyzed. Fresh surgical margins were scanned intraoperatively using the Histolog® Scanner prior to conventional frozen section analysis. Histolog® images were retrospectively reviewed by a blinded pathologist and compared with conventional intraoperative frozen section histopathology, considered the reference standard. The evaluated parameters included overall concordance, sensitivity, specificity, positive predictive value, and negative predictive value, when estimable, as well as workflow times. Results: All 95 submitted margins were successfully scanned and evaluated. According to the reference standard, all margins were negative. Histolog® correctly classified 94 of 95 margins, with one false-positive result, yielding an overall concordance of 98.95% and a specificity of 98.95%. No false-negative results were observed, and the negative predictive value was 100%. Sensitivity and positive predictive value could not be estimated due to the absence of positive margins at the reference standard. The mean total Histolog® workflow time was significantly shorter than the mean frozen section turnaround time (27.81 vs 63.92 minutes; p = 0.000488), corresponding to a mean time saving of 36.11 minutes. The mean per-margin Histolog® workflow time was 4.06 minutes. A significant positive correlation was observed between the number of margins and Histolog® workflow time (p = 0.039). Conclusion: Histolog® Scanner appears to be a feasible tool for intraoperative assessment of tongue resection margins in oral cavity squamous cell carcinoma, showing high concordance, specificity, and negative predictive value, together with a significant reduction in workflow time. However, further prospective studies including larger cohorts and both positive and negative margins are required to fully characterize the diagnostic performance of Histolog® and define its role in the intraoperative management of oral cavity squamous cell carcinoma.