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[基于1610例直肠癌手术后非肿瘤相关吻合口狭窄患者数据的多因素分析及列线图模型的构建与验证]

[Multivariate analysis and construction and validation of a nomogram model from data of 1610 patients with non-tumor-related anastomotic stenosis after rectal cancer surgery].

作者信息

Qiu K M, Jian W, Zheng J X, Feng M Y, Liu X M, Lu D S, Yan J

机构信息

Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.

出版信息

Zhonghua Wei Chang Wai Ke Za Zhi. 2024 Jun 25;27(6):600-607. doi: 10.3760/cma.j.cn441530-20230926-00112.

Abstract

To assess the risk factors affecting development of non-tumor- related anastomotic stenosis after rectal cancer and to construct a nomogram prediction model. This was a retrospective study of data of patients who had undergone excision with one-stage intestinal anastomosis for rectal cancer between January 2003 and September 2018 in Nanfang Hospital of Southern Medical University. The exclusion criteria were as follows: (1) pathological examination of the operative specimen revealed residual tumor on the incision margin of the anastomosis; (2) pathological examination of postoperative colonoscopy specimens revealed tumor recurrence at the anastomotic stenosis, or postoperative imaging evaluation and tumor marker monitoring indicated tumor recurrence; (3) follow-up time <3 months; and (4) simultaneous multiple primary cancers. Univariate analysis using the χ or Fisher's exact test was performed to assess the study patients' baseline characteristics and variables such as tumor-related factors and surgical approach (<0.05). Multivariate analysis using binary logistic regression was then performed to identify independent risk factors for development of non-tumor-related anastomotic stenosis after rectal cancer. Finally, a nomogram model for predicting non-tumor-related anastomotic stenosis after rectal cancer surgery was constructed using R software. The reliability and accuracy of this prediction model was evaluated using internal validation and calculation of the area under the curve of the model's receiver characteristic curve (ROC). The study cohort comprised 1,610 patients, including 1,008 men and 602 women of median age 59 (50, 67) years and median body mass index 22.4 (20.2, 24.5) kg/m². Non-tumor-related anastomotic stenosis developed in 121 (7.5%) of these patients. The incidence of non-tumor-related anastomotic stenosis in patients who had undergone neoadjuvant chemotherapy, neoadjuvant radiotherapy, and surgery alone was 11.2% (10/89), 26.4% (47/178), and 4.8% (64/1,343), respectively. Neoadjuvant treatment (neoadjuvant chemotherapy: OR=2.455, 95%CI: 1.148-5.253, =0.021; neoadjuvant chemoradiotherapy, OR=3.882, 95%CI: 2.425-6.216, <0.001), anastomotic leakage (OR=7.960, 95%CI: 4.550-13.926, <0.001), open laparotomy (OR=3.412, 95%CI: 1.772-6.571, <0.001), and tumor location (distance of tumor from the anal verge 5-10 cm: OR=2.381, 95%CI:1.227-4.691, <0.001; distance of tumor from the anal verge <5 cm: OR=5.985,95% CI: 3.039-11.787, <0.001) were identified as independent risk factors for non-tumor-related anastomotic stenosis. Thereafter, a nomogram prediction model incorporating the four identified risk factors for development of anastomotic stenosis after rectal cancer was developed. The area under the curve of the model ROC was 0.815 (0.773-0.857, <0.001), and the C-index of the predictive model was 0.815, indicating that the model's calibration curve fitted well with the ideal curve. Non-tumor-related anastomotic stenosis after rectal cancer surgery is significantly associated with neoadjuvant treatment, anastomotic leakage, surgical procedure, and tumor location. A nomogram based on these four factors demonstrated good discrimination and calibration, and would therefore be useful for screening individuals at risk of anastomotic stenosis after rectal cancer surgery.

摘要

评估影响直肠癌术后非肿瘤相关吻合口狭窄发生的危险因素,并构建列线图预测模型。本研究回顾性分析了2003年1月至2018年9月在南方医科大学南方医院接受直肠癌一期肠吻合切除术患者的数据。排除标准如下:(1)手术标本病理检查显示吻合口切缘有残留肿瘤;(2)术后结肠镜标本病理检查显示吻合口狭窄处有肿瘤复发,或术后影像学评估及肿瘤标志物监测提示肿瘤复发;(3)随访时间<3个月;(4)同时患有多发原发性癌症。采用χ²检验或Fisher精确检验进行单因素分析,以评估研究患者的基线特征以及肿瘤相关因素和手术方式等变量(P<0.05)。随后采用二元逻辑回归进行多因素分析,以确定直肠癌术后非肿瘤相关吻合口狭窄发生的独立危险因素。最后,使用R软件构建直肠癌术后非肿瘤相关吻合口狭窄的列线图预测模型。通过内部验证和计算模型受试者特征曲线(ROC)下面积评估该预测模型的可靠性和准确性。研究队列包括1610例患者,其中男性1008例,女性602例,中位年龄59(50,67)岁,中位体重指数22.4(20.2,24.5)kg/m²。这些患者中121例(7.5%)发生了非肿瘤相关吻合口狭窄。接受新辅助化疗、新辅助放疗及单纯手术患者的非肿瘤相关吻合口狭窄发生率分别为11.2%(10/89)、26.4%(47/178)和4.8%(64/1343)。新辅助治疗(新辅助化疗:OR=2.455,95%CI:1.148 - 5.253,P=0.021;新辅助放化疗,OR=3.882,95%CI:2.425 - 6.216,P<0.001)、吻合口漏(OR=7.960,95%CI:4.550 - 13.926,P<0.001)、开腹手术(OR=3.412,95%CI:1.772 - 6.571,P<0.001)以及肿瘤位置(肿瘤距肛缘5 - 10 cm:OR=2.381,95%CI:1.227 - 4.691,P<0.001;肿瘤距肛缘<5 cm:OR=5.985,95%CI:3.039 - 11.787,P<0.001)被确定为非肿瘤相关吻合口狭窄的独立危险因素。此后,构建了一个纳入上述四个已确定的直肠癌术后吻合口狭窄发生危险因素的列线图预测模型。模型ROC曲线下面积为0.815(0.773 - 0.857,P<0.001),预测模型的C指数为0.815,表明模型校准曲线与理想曲线拟合良好。直肠癌术后非肿瘤相关吻合口狭窄与新辅助治疗、吻合口漏、手术方式及肿瘤位置显著相关。基于这四个因素的列线图显示出良好的区分度和校准度,因此可用于筛查直肠癌术后有吻合口狭窄风险的个体。

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