Division of Surgery and Interventional Science, University College London, London, UK.
Department of Urology, Westmoreland Street Hospital, University College Hospital London, London, UK.
BJU Int. 2021 Jun;127(6):676-686. doi: 10.1111/bju.15256. Epub 2021 Mar 29.
To report on the methods, peri-operative outcomes and histopathological concordance between frozen and final section from the NeuroSAFE PROOF feasibility study (NCT03317990).
Between May 2018 and March 2019, 49 patients at two UK centres underwent robot-assisted radical prostatectomy (RARP). Twenty-five patient were randomized to NeuroSAFE RARP (intervention arm) and 24 to standard RARP (control arm). Frozen section was compared to final paraffin section margin assessment in the 25 patients in the NeuroSAFE arm. Operation timings and complications were collected prospectively in both arms.
Fifty neurovascular bundles (NVBs) from 25 patients in the NeuroSAFE arm were analysed. When analysed by each pathological section (n = 250, average five per side), we noted a sensitivity of 100%, a specificity of 99.2%, and an area under the curve (AUC) of 0.994 (95% confidence interval [CI] 0.985 to 1; P ≤0.001). On an NVB basis (n = 50), sensitivity was 100%, specificity was 92.7%, and the AUC was 0.963 (95% CI 0.914 to 1; P ≤0.001). NeuroSAFE RARP lasted a mean of 3 h 16 min (knife to skin to off table, 95% CI 3 h 2 min-3 h 30 min) compared to 2 h 4 min (95% CI 2 h 2 min-2 h 25 min; P ≤0.001) for standard RARP. There was no morbidity associated with the additional length of operating time on in the NeuroSAFE arm.
This feasibility study demonstrates the safety, reproducibility and excellent histopathological concordance of the NeuroSAFE technique in the NeuroSAFE PROOF trial. Although the technique increases the duration of RARP, this does not cause short-term harm. Confirmation of feasibility has led to the opening of the fully powered NeuroSAFE PROOF randomized controlled trial, which is currently under way at four sites in the UK.
报告来自 NeuroSAFE PROOF 可行性研究（NCT03317990）的冷冻和最终切片之间的方法、围手术期结果和组织病理学一致性。
2018 年 5 月至 2019 年 3 月，英国的两个中心的 49 名患者接受了机器人辅助根治性前列腺切除术（RARP）。25 名患者被随机分配到神经安全 RARP（干预组），24 名患者分到标准 RARP（对照组）。在神经安全组的 25 名患者中，对冷冻切片与最终石蜡切片边缘评估进行了比较。在两组中都前瞻性地收集了手术时间和并发症数据。
对神经安全组的 25 名患者的 50 个神经血管束（NVB）进行了分析。当按每个病理切片进行分析（n=250，平均每侧 5 个）时，我们注意到灵敏度为 100%，特异性为 99.2%，曲线下面积（AUC）为 0.994（95%置信区间 [CI] 0.985 至 1；P≤0.001）。基于 NVB （n=50），灵敏度为 100%，特异性为 92.7%，AUC 为 0.963（95% CI 0.914 至 1；P≤0.001）。神经安全 RARP 的平均用时为 3 小时 16 分钟（刀到皮肤到离开手术台，95%CI 3 小时 2 分钟-3 小时 30 分钟），而标准 RARP 的平均用时为 2 小时 4 分钟（95%CI 2 小时 2 分钟-2 小时 25 分钟；P≤0.001）。在神经安全组中，额外的手术时间没有导致任何发病率。
这项可行性研究证明了 NeuroSAFE 技术在 NeuroSAFE PROOF 试验中的安全性、可重复性和出色的组织病理学一致性。尽管该技术增加了 RARP 的持续时间，但并没有造成短期伤害。可行性的确认已经导致了完全有效的 NeuroSAFE PROOF 随机对照试验的开放，该试验目前正在英国的四个地点进行。
