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在合并症较多的虚弱患者中施行部分肾切除术治疗肾细胞癌是否安全有效?来自 RECORD 2 多中心前瞻性研究的结果。

Is partial nephrectomy safe and effective in the setting of frail comorbid patients affected by renal cell carcinoma? Insights from the RECORD 2 multicentre prospective study.

机构信息

Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, Turin, Italy.

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

出版信息

Urol Oncol. 2021 Jan;39(1):78.e17-78.e26. doi: 10.1016/j.urolonc.2020.09.022. Epub 2020 Oct 27.

Abstract

BACKGROUND

To investigate the perioperative and morbidity outcomes after partial nephrectomy (PN) in patients with short life expectancy (SLE) (≥95% 10-year expected mortality (10y-EM)), to assess the main predictors of outcomes in this population and to compare these results with those of a group at the opposite upper range with long LE (LLE, ≤5% 10y-EM) relying on a multicenter Italian prospective registry of kidney surgery (the RECORD 2 project).

METHODS

Clinical data of 4,325 patients undergone kidney surgery were collected at 26 urological Italian Centers from 2013 to 2016. SLE was defined as a ≥95% 10y-EM (assessed using the age-adjusted Charlson comorbidity index [CCI]). A multivariable logistic regression for overall postoperative complications, acute kidney injury (AKI), positive surgical margins (SM) and ∆ estimated glomerular filtration rate (eGFR) ≥25% at 2 years from surgery was performed in patients with SLE including clinically relevant variables. Adjusted outcomes reported as mean (SD) of the 2 groups were generated using separate multivariable logistic regression models and compared.

RESULTS

Overall, 559 patients with SLE were selected. Patients had an ASA score ≥3 in 58.4% of cases. A clinical T1a, T1b, and T2 stage was found in 412 (74.5%), 124 (22.4%), and 17 (3.1%) patients. The median PADUA score was 7 (6-8). Surgical and medical postoperative complication rates were registered in 14.8% and 6% cases. Postoperative AKI was reported in 27.3% cases, positive surgical margins (PSM) in 9.3% cases. In this subgroup of patients, ASA score, cerebrovascular disease, surgery in low volume centers, and open surgery were independent predictors of overall complications. ASA and PADUA scores, renal clamping, resection technique and lower eGFR at baseline were independent predictors of AKI. PADUA score, open approach and resection technique were independent predictors of PSM. Cardiovascular disease, hilar clamping, and resection technique were independent predictors of eGFR decrease >25% at 2 years from surgery. Patients with SLE were compared with those with LLE (n = 302). All analyzed parameters at baseline were significantly different among the groups with the exception of cancer laterality. After adjusting for several clinical variables, the SLE group had a significantly higher risk rate of adjusted overall postoperative complication rate compared to the LLE group (20.6% ± 0.36 vs. 9.9% ± 0.65, P < 0.0001), while the overall intraoperative complications (4.1% ±0.13 vs. 2.3% ± 0.23), overall postoperative major complications (3.8% ± 0.09 vs. 1.9% ± 0.14) adjusted AKI (24.2% ± 0.37 vs. 22.6% ± 0.92), positive surgical margins (8% ± 0.22 vs. 6.4% ± 0.49), and 2-year RF loss (13.4% ± 0.17 vs. 12.4% ± 0.74).

CONCLUSION

In selected patients with SLE, PN is feasible with an acceptable safety profile that is overall comparable to patients with no LE limitations. While a robotic approach and surgery performed in high volume centers could reduce the risk of complications, an off-clamp approach and a SE surgical technique may decrease the risk of postoperative AKI and of longer term eGFR decrease.

摘要

背景

本研究旨在探讨短预期寿命(SLE,≥95%10 年预期死亡率(10y-EM))患者行部分肾切除术(PN)的围手术期和发病率结果,评估该人群中主要结局的预测因素,并将这些结果与相反的长预期寿命(LLE,≤5%10y-EM)患者进行比较,研究数据来自于意大利多中心肾脏手术前瞻性登记研究(RECORD 2 项目)。

方法

2013 年至 2016 年,在 26 家意大利泌尿科中心收集了 4325 例接受肾脏手术患者的临床数据。SLE 定义为≥95%10y-EM(使用年龄调整后的 Charlson 合并症指数 [CCI] 评估)。在 SLE 患者中进行了一项多变量逻辑回归分析,以评估总体术后并发症、急性肾损伤(AKI)、阳性手术切缘(SM)和术后 2 年估算肾小球滤过率(eGFR)下降≥25%的情况,包括临床相关变量。采用单独的多变量逻辑回归模型生成调整后结局的均值(SD),并进行比较。

结果

共选择了 559 例 SLE 患者。58.4%的患者 ASA 评分≥3。412 例(74.5%)、124 例(22.4%)和 17 例(3.1%)患者分别为临床 T1a、T1b 和 T2 期。中位 PADUA 评分为 7(6-8)。14.8%和 6%的病例分别记录了手术和术后内科并发症。27.3%的病例发生术后 AKI,9.3%的病例发生阳性手术切缘(PSM)。在这组患者中,ASA 评分、脑血管疾病、低容量中心手术和开放手术是总体并发症的独立预测因素。ASA 和 PADUA 评分、肾脏夹闭、切除技术和基线时较低的 eGFR 是 AKI 的独立预测因素。PADUA 评分、开放方法和切除技术是 PSM 的独立预测因素。心血管疾病、肾门夹闭和切除技术是术后 2 年 eGFR 下降>25%的独立预测因素。将 SLE 患者与 LLE 患者(n=302)进行比较。除了肿瘤侧别外,各组在基线时的所有分析参数均有显著差异。在调整了几个临床变量后,SLE 组与 LLE 组相比,术后总体并发症发生率的调整风险率显著更高(20.6%±0.36 vs. 9.9%±0.65,P<0.0001),而总体术中并发症(4.1%±0.13 vs. 2.3%±0.23)、总体术后主要并发症(3.8%±0.09 vs. 1.9%±0.14)、调整后的 AKI(24.2%±0.37 vs. 22.6%±0.92)、阳性手术切缘(8%±0.22 vs. 6.4%±0.49)和 2 年 RF 丢失(13.4%±0.17 vs. 12.4%±0.74)。

结论

在选择的 SLE 患者中,PN 是可行的,安全性可接受,总体上与无 LE 限制的患者相当。虽然机器人手术和在高容量中心进行的手术可以降低并发症风险,但非夹闭手术和 SE 手术技术可能会降低术后 AKI 和长期 eGFR 下降的风险。

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