BackgroundRadical prostatectomy (RP) represents the cornerstone of surgical treatment for prostate cancer. Assessing surgical margin status intraoperatively with current techniques remains challenging due to high costs in the context of an already stretched pathology workforce. Fluorescence confocal microscopy (FCM) is a promising technique to detect margins in prostate cancer surgery not bound by such limitations.Study DesignThe Imperial Prostate 8 – Fluorescence Confocal Microscopy for Rapid Evaluation of Surgical Cancer Excision (IP8‐FLUORESCE) study is a multicentre, prospective, ex vivo, ‘blinded’, comparative cohort study. It aims to assess the accuracy of digital FCM for detection of prostate cancer at surgical margins compared to traditional histopathology.EndpointsThe primary endpoint is the accuracy of digital FCM for detection of prostate cancer at surgical margins on a per‐patient level, reported with sensitivity, specificity, positive and negative predictive values.Patients and MethodsA total of 153 patients with localised prostate cancer undergoing robot‐assisted RP across three UK National Health Service tertiary referral centres will be recruited. Following RP, prostate specimens will undergo immediate immersion in Acridine Orange solution, scanning ‘en face’ with FCM using the Histolog® Scanner, and subsequent formalin fixation and paraffin embedding. Two independent, ‘blinded’ uro‐pathologists will report both the FCM images and the histopathology slides. Recruitment commenced on 17 August 2023.

中文翻译：

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用于前列腺切除术切缘评估的荧光共聚焦显微镜检查：IP8-FLUORESCE 研究方案


背景根治性前列腺切除术 （RP） 是前列腺癌手术治疗的基石。在已经捉襟见肘的病理学劳动力的情况下，由于成本高昂，使用当前技术在术中评估手术切缘状态仍然具有挑战性。荧光共聚焦显微镜 （FCM） 是一种很有前途的技术，可以在不受此类限制的前列腺癌手术中检测切缘。研究设计Imperial Prostate 8 – 用于手术癌症切除快速评估 （IP8-FLUORESCE） 的荧光共聚焦显微镜是一项多中心、前瞻性、离体、“盲法”、比较队列研究。它旨在评估与传统组织病理学相比，数字 FCM 在手术切缘检测前列腺癌方面的准确性。终点主要终点是数字 FCM 在每位患者水平手术切缘检测前列腺癌的准确性，报告了敏感性、特异性、阳性和阴性预测值。患者和方法将招募三个英国国家卫生服务三级转诊中心共招募 153 名接受机器人辅助 RP 的局限性前列腺癌患者。RP 后，前列腺标本将立即浸入 Acridine Orange 溶液中，使用 Histolog® 扫描仪用 FCM 扫描“面部”，随后进行福尔马林固定和石蜡包埋。两名独立的“盲法”泌尿病理学家将报告 FCM 图像和组织病理学载玻片。招聘于 2023 年 8 月 17 日开始。