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Randomized Controlled Trial
. 2025 Feb;86(3):433-440.
doi: 10.1111/his.15336. Epub 2024 Oct 15.

Accuracy of the LaserSAFE technique for detecting positive surgical margins during robot-assisted radical prostatectomy: blind assessment and inter-rater agreement analysis

Ricardo Almeida-Magana  1   2 , Matthew Au  1 , Tarek Al-Hammouri  2   3 , Manju Mathew  3   4 , Kate Dinneen  4 , Larissa S T Mendes  1   4 , Eoin Dinneen  2 , Willem Vreuls  5   6 , Greg Shaw  1   2 , Alex Freeman  4 , Aiman Haider  4
Affiliations
Randomized Controlled Trial

Accuracy of the LaserSAFE technique for detecting positive surgical margins during robot-assisted radical prostatectomy: blind assessment and inter-rater agreement analysis

Ricardo Almeida-Magana et al. Histopathology. 2025 Feb.

Abstract

Introduction and objectives: Fluorescence confocal microscopy (FCM) is a new imaging modality capable of generating digital microscopic resolution scans of fresh surgical specimens, and holds potential as an alternative to frozen section (FS) analysis for intra-operative assessment of surgical margins. Previously, we described the LaserSAFE technique as an application of FCM for margin assessment in robot-assisted radical prostatectomy (RARP) using the Histolog® scanner. This study describes the accuracy and inter-rater agreement of FCM imaging compared to corresponding paraffin-embedded analysis (PA) among four blinded pathologists for the presence of positive surgical margins (PSM).

Materials and methods: RARP specimens from patients enrolled in the control arm of the NeuroSAFE PROOF study (NCT03317990) were analysed from April 2022 to February 2023. Prostate specimens were imaged using the Histolog® scanner before formalin fixation and PA. Four trained assessors, blinded to PA, reviewed and analysed FCM images of the posterolateral prostatic surface.

Results: A total of 31 prostate specimens were included in the study. PA per lateral side of the prostate identified 11 instances of positive margins. Among the four histopathologists included in our study, FCM achieved a sensitivity of 73-91 and specificity of 94-100% for the presence of PSM. Fleiss' Kappa for inter-rater agreement on PSM was 0.78 (95% confidence interval = 0.64-0.92), indicating substantial agreement.

Conclusion: This blinded analysis of FCM versus PA among histopathologists with different experience levels demonstrated high accuracy and substantial inter-rater agreement for diagnosing PSM. This supports the role of the FCM as an alternative to FS.

Keywords: fluorescence confocal microscopy; frozen section analysis; margin assessment; prostate cancer.

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Conflict of interest statement

R.A.M. receives a salary from NIHR RFPB PB‐PG‐1216‐20013 and PCUK MA‐CT20‐11. G.S. receives consulting fees from Angle plc and has received travel expenses from Janssen and Johnson and Johnson (not related to the present manuscript). M.A., T.Al‐H., K.D, L.S.T.M., E.D., W.V., A.F. and A.H. report no conflicts of interest related to this work. SamanTree Medical SA (Lausanne, Switzerland) provided the Histolog® scanner, training and consumables but was not involved in the study design, execution, results or writing of the manuscript.

Figures

Figure 1
Figure 1
A, The prostate specimen is placed with the area of interest in contact with the microscope objective and stabilised using a purposely built specimen holder. B, The macroscopic high‐resolution image can be scanned for areas of interest. C, Magnification of glandular structures suggestive of a positive margin. D, Corresponding paraffin‐embedded haematoxylin and eosin image with malignant glands in contact with the ink. [Color figure can be viewed at wileyonlinelibrary.com]
Figure 2
Figure 2
Distribution of cases according to the technique used to acquire fluorescence confocal microscopy images. [Color figure can be viewed at wileyonlinelibrary.com]
See this image and copyright information in PMC

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