Anser Prostate operation Clinic, Rotterdam.
Department of Pathology, Maasstad Hospital, Rotterdam.
BJU Int. 2022 Nov;130(5):628-636. doi: 10.1111/bju.15771. Epub 2022 Jun 5.
To investigate the impact of intra-operative neurovascular structure-adjacent frozen-section examination (NeuroSAFE) on the rate of nerve-sparing surgery (NSS) and oncological outcome in a large radical prostatectomy (RP) cohort.
Between January 2016 and December 2020, 1756 prostate cancer patients underwent robot-assisted RP, of whom 959 (55%) underwent this with NeuroSAFE and 797 (45%) without (control cohort). In cases where NeuroSAFE showed tumour in the margin, a secondary resection was performed. The effect of NeuroSAFE on NSS and positive surgical margin (PSM) status was analysed using logistic regression. Cox regression was used to identify predictors of biochemical recurrence-free survival (BCRFS).
Patients in the NeuroSAFE cohort had a higher tumour grade (P < 0.001) and clinical stage (P < 0.001) than those in the control cohort. NeuroSAFE enabled more frequent NSS for both pT2 (93% vs 76%; P < 0.001) and pT3 disease (83% vs 55%; P < 0.001). In adjusted analysis, NeuroSAFE resulted in more frequent unilateral (odds ratio [OR] 3.90, 95% confidence interval (CI) 2.90-5.30; P < 0.001) and bilateral (OR 5.22, 95% CI 3.90-6.98; P < 0.001) NSS. While the PSM rate decreased from 51% to 42% in patients with pT3 stage disease (P = 0.031), NeuroSAFE was not an independent predictor of PSM status (OR 0.85, 95% CI 0.68-1.06; P = 0.2) in the entire cohort. Patients who underwent NeuroSAFE had better BCRFS compared to the control cohort (hazard ratio 0.62, 95% CI 0.45-0.84; P = 0.002). This study is limited by its comparison with a historical cohort and lack of functional outcomes.
NeuroSAFE enables more unilateral and bilateral NSS without negatively affecting surgical margin status and biochemical recurrence. This validation study provides a comprehensive overview of the implementation, evaluation and intra-operative decision making associated with NeuroSAFE in clinical practice.
研究术中神经血管毗邻组织冷冻切片检查（NeuroSAFE）对大样本前列腺根治性切除术（RP）中保神经手术（NSS）率和肿瘤学结果的影响。
2016 年 1 月至 2020 年 12 月，1756 例前列腺癌患者接受机器人辅助 RP，其中 959 例（55%）接受了神经血管毗邻组织冷冻切片检查（NeuroSAFE），797 例（45%）未接受（对照组）。如果神经血管毗邻组织冷冻切片检查发现边缘有肿瘤，则进行二次切除。使用逻辑回归分析神经血管毗邻组织冷冻切片检查对 NSS 和阳性手术切缘（PSM）状态的影响。Cox 回归用于确定生化无复发生存率（BCRFS）的预测因素。
神经血管毗邻组织冷冻切片检查组患者的肿瘤分级（P < 0.001）和临床分期（P < 0.001）均高于对照组。神经血管毗邻组织冷冻切片检查使更多的 pT2（93% vs 76%；P < 0.001）和 pT3 疾病（83% vs 55%；P < 0.001）患者获得了更频繁的 NSS。在调整分析中，神经血管毗邻组织冷冻切片检查使单侧（优势比[OR] 3.90，95%置信区间[CI] 2.90-5.30；P < 0.001）和双侧（OR 5.22，95% CI 3.90-6.98；P < 0.001）NSS 更为常见。尽管在 pT3 期疾病患者中，PSM 率从 51%降至 42%（P = 0.031），但神经血管毗邻组织冷冻切片检查在整个队列中并不是 PSM 状态的独立预测因素（OR 0.85，95% CI 0.68-1.06；P = 0.2）。与对照组相比，接受神经血管毗邻组织冷冻切片检查的患者具有更好的 BCRFS（风险比 0.62，95% CI 0.45-0.84；P = 0.002）。本研究的局限性在于其与历史队列的比较以及缺乏功能结果。
神经血管毗邻组织冷冻切片检查可实现更多的单侧和双侧 NSS，而不会对手术切缘状态和生化复发产生负面影响。这项验证研究全面概述了神经血管毗邻组织冷冻切片检查在临床实践中的实施、评估和术中决策。
