Ricardo Almeida‐Magana, Larissa Sena Teixeira Mendes, Eoin Dinneen, Tarek Al‐Hammouri, Aiman Haider, Anna Silvanto, Alex Freeman, Nicholas Roberts, Louise Dickinson, Chun Wah So, Zafer Tandogdu, Benjamin W. Lamb, Nikhil Mayor, Mathias Winkler, Hashim Ahmed, Greg Shaw
Objectives To assess the feasibility of conducting a multicentre trial comparing NeuroSAFE with a novel technique based on confocal laser microscopy (LaserSAFE) and evaluate the diagnostic performance of LaserSAFE for real‐time surgical margin assessment. Patients and Methods This was a non‐randomised, prospective feasibility study conducted at a high‐volume academic UK centre ( ClinicalTrials.gov identifier: NCT06398470). Patients with localised prostate cancer (clinical T2–T3a N0 M0) scheduled for robot‐assisted radical prostatectomy and deemed unsuitable for bilateral intrafascial nerve sparing (NS) based on a multidisciplinary plan were included. LaserSAFE imaging was performed in the operating room after which the NeuroSAFE technique results guided NS decisions. Pathologists, blinded to NeuroSAFE and final histology, retrospectively evaluated LaserSAFE images. Diagnostic accuracy metrics and concordance between modalities were calculated. Feasibility was assessed based on recruitment rate and the ability to activate additional sites. Results A total of 20 patients were recruited at a single site within 12 months of recruitment start. However, expansion to additional centres was not feasible due to limitations in implementing the NeuroSAFE protocol. LaserSAFE achieved a sensitivity of 0.91 (95% confidence interval [CI] 0.59–1.00) and specificity of 1.00 (95% CI 0.88–1.00) for detecting positive surgical margins ≥0.5 mm. Cohen's kappa demonstrated strong agreement with NeuroSAFE and final pathology. LaserSAFE was completed within a median of 7 min, significantly shorter than the 63 min required for NeuroSAFE. Limitations include the small sample size, single‐centre setting, and lack of intraoperative decision‐making based on LaserSAFE findings. Conclusion While a multicentre study based on NeuroSAFE as a comparison was not achievable, LaserSAFE proved to be a rapid and accurate alternative for intraoperative margin assessment. These findings support the design of a larger trial in which NS decisions are informed by LaserSAFE, with a view to broadening access to real‐time margin assessment.
目的评估开展多中心试验比较NeuroSAFE与基于共聚焦激光显微镜(LaserSAFE)的新技术的可行性,并评估LaserSAFE在实时手术边缘评估中的诊断性能。患者和方法:这是一项在英国一个高容量学术中心进行的非随机、前瞻性可行性研究(ClinicalTrials.gov识别码:NCT06398470)。本研究纳入了计划接受机器人辅助根治性前列腺切除术的局限性前列腺癌患者(临床T2-T3a N0 M0),并基于多学科计划认为不适合双侧筋膜内神经保留(NS)。在手术室进行LaserSAFE成像,之后NeuroSAFE技术结果指导NS决策。病理学家对NeuroSAFE和最终组织学不知情,回顾性评估LaserSAFE图像。计算诊断准确性指标和模式之间的一致性。可行性是根据征聘率和激活其他地点的能力来评估的。结果在招募开始的12个月内,在单个地点共招募了20例患者。然而,由于实施NeuroSAFE方案的限制,扩展到其他中心是不可行的。LaserSAFE检测≥0.5 mm阳性手术切缘的灵敏度为0.91(95%可信区间[CI] 0.59-1.00),特异性为1.00 (95% CI 0.88-1.00)。Cohen的kappa与NeuroSAFE和最终病理结果一致。LaserSAFE的平均完成时间为7分钟,明显短于NeuroSAFE所需的63分钟。局限性包括样本量小,单中心设置,以及缺乏基于LaserSAFE结果的术中决策。结论:虽然基于NeuroSAFE作为比较的多中心研究无法实现,但LaserSAFE被证明是术中边缘评估的快速和准确的替代方法。这些发现支持更大规模试验的设计,在该试验中,NS决策由LaserSAFE提供信息,以扩大实时边际评估的范围。
{"title":"The LaserSAFE technique for margin assessment during radical prostatectomy: a feasibility study","authors":"Ricardo Almeida‐Magana, Larissa Sena Teixeira Mendes, Eoin Dinneen, Tarek Al‐Hammouri, Aiman Haider, Anna Silvanto, Alex Freeman, Nicholas Roberts, Louise Dickinson, Chun Wah So, Zafer Tandogdu, Benjamin W. Lamb, Nikhil Mayor, Mathias Winkler, Hashim Ahmed, Greg Shaw","doi":"10.1111/bju.70092","DOIUrl":"https://doi.org/10.1111/bju.70092","url":null,"abstract":"Objectives To assess the feasibility of conducting a multicentre trial comparing NeuroSAFE with a novel technique based on confocal laser microscopy (LaserSAFE) and evaluate the diagnostic performance of LaserSAFE for real‐time surgical margin assessment. Patients and Methods This was a non‐randomised, prospective feasibility study conducted at a high‐volume academic UK centre ( <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" xlink:href=\"http://clinicaltrials.gov\">ClinicalTrials.gov</jats:ext-link> identifier: NCT06398470). Patients with localised prostate cancer (clinical T2–T3a N0 M0) scheduled for robot‐assisted radical prostatectomy and deemed unsuitable for bilateral intrafascial nerve sparing (NS) based on a multidisciplinary plan were included. LaserSAFE imaging was performed in the operating room after which the NeuroSAFE technique results guided NS decisions. Pathologists, blinded to NeuroSAFE and final histology, retrospectively evaluated LaserSAFE images. Diagnostic accuracy metrics and concordance between modalities were calculated. Feasibility was assessed based on recruitment rate and the ability to activate additional sites. Results A total of 20 patients were recruited at a single site within 12 months of recruitment start. However, expansion to additional centres was not feasible due to limitations in implementing the NeuroSAFE protocol. LaserSAFE achieved a sensitivity of 0.91 (95% confidence interval [CI] 0.59–1.00) and specificity of 1.00 (95% CI 0.88–1.00) for detecting positive surgical margins ≥0.5 mm. Cohen's kappa demonstrated strong agreement with NeuroSAFE and final pathology. LaserSAFE was completed within a median of 7 min, significantly shorter than the 63 min required for NeuroSAFE. Limitations include the small sample size, single‐centre setting, and lack of intraoperative decision‐making based on LaserSAFE findings. Conclusion While a multicentre study based on NeuroSAFE as a comparison was not achievable, LaserSAFE proved to be a rapid and accurate alternative for intraoperative margin assessment. These findings support the design of a larger trial in which NS decisions are informed by LaserSAFE, with a view to broadening access to real‐time margin assessment.","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"7 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145611132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}