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预测部分肾切除术的阳性手术切缘:一项前瞻性多中心观察研究(RECORd 2 项目)。

Predicting positive surgical margins in partial nephrectomy: A prospective multicentre observational study (the RECORd 2 project).

机构信息

Department of Urology, University of Bologna, Department of Experimental, Diagnostic, and Specialty Medicine, University of Bologna, Bologna, Italy.

Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital, Florence, Italy.

出版信息

Eur J Surg Oncol. 2020 Jul;46(7):1353-1359. doi: 10.1016/j.ejso.2020.01.022. Epub 2020 Jan 22.

DOI:10.1016/j.ejso.2020.01.022
PMID:32007380
Abstract

PURPOSE

to evaluate clinical predictors of positive surgical margins (PSMs) in a large multicenter prospective observational study and to develop a clinic nomogram to predict the likelihood of PSMs after partial nephrectomy (PN).

MATERIALS AND METHODS

We prospectively evaluated 4308 patients who had surgical treatment for renal tumors between January 2013 and December 2016 at 26 urological Italian Centers (RECORd 2 project). Two multivariable logistic models were evaluated to predict the likelihood of PSMs. Center caseload was dichotomized using a visual assessment adjusted for several predictors of PSMs. A nomogram predicting PSMs was developed.

RESULTS

Overall, 2076 patients treated with PN were evaluated. pT1a, pT1b, pT2 and pT3a were recorded in 68.7%, 22.6%, 2.1% and 6.6% of the patients, respectively. PSMs were recorded in 342 (16.5%) patients. From a null multivariable model against number of PN/year, 60 PN/year were identified as the best cut-off to define a high-volume centre. At multivariable analysis, clinical stage (cT1a vs. cT2 [OR 1.94]; p = 0.03), volume centre (≤60 PN/year) (OR 2.22; p < 0.0001), imperative vs elective indication (OR 2.10; p = 0.04), surgical technique (laparoscopic vs. open [OR 1.62; p = 0.002), lymphovascular invasion (OR 2.27; p = 0.01) and upstaging to pT3a (OR 2.81; p < 0.0001) were independent predictors of PSMs. The final nomogram included age, ASA score, Charlson score, clinical tumor stage, surgical indication, surgical approach, surgical technique, PADUA score, clamp procedure and volume centre.

CONCLUSIONS

PSMs after PN were significantly more likely in patients with lower clinical stage, higher PADUA score, in individuals referred to laparoscopic PN and in those treated at lower volume centers. We used these data to develop a nomogram to predict such risk.

摘要

目的

在一项大型多中心前瞻性观察研究中评估阳性手术切缘(PSM)的临床预测因素,并制定临床列线图预测部分肾切除术(PN)后 PSM 的可能性。

材料和方法

我们前瞻性评估了 2013 年 1 月至 2016 年 12 月期间在 26 个意大利泌尿科中心接受手术治疗的 4308 例肾肿瘤患者(RECORd 2 项目)。评估了两种多变量逻辑模型以预测 PSM 的可能性。中心例数使用视觉评估进行二分法,该评估针对 PSM 的几个预测因素进行了调整。开发了一个预测 PSM 的列线图。

结果

总体而言,评估了 2076 例接受 PN 治疗的患者。患者中分别记录了 pT1a、pT1b、pT2 和 pT3a 为 68.7%、22.6%、2.1%和 6.6%。342 例(16.5%)患者记录了 PSM。从针对每年 PN 数量的零多变量模型中,确定 60 例 PN/年作为定义高容量中心的最佳截止值。多变量分析显示,临床分期(cT1a 与 cT2 [OR 1.94];p=0.03)、体积中心(≤60 例 PN/年)(OR 2.22;p<0.0001)、紧急与择期指征(OR 2.10;p=0.04)、手术技术(腹腔镜与开放 [OR 1.62;p=0.002])、脉管侵犯(OR 2.27;p=0.01)和升级为 pT3a(OR 2.81;p<0.0001)是 PSM 的独立预测因素。最终的列线图包括年龄、ASA 评分、Charlson 评分、临床肿瘤分期、手术指征、手术方式、手术技术、PADUA 评分、夹闭程序和体积中心。

结论

PN 后 PSM 更可能发生在临床分期较低、PADUA 评分较高、接受腹腔镜 PN 治疗和在低容量中心治疗的患者中。我们使用这些数据制定了一个预测这种风险的列线图。

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