Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
Department of Statistics, University of Bologna, Bologna, Italy.
Gastrointest Endosc. 2016 Apr;83(4):746-52. doi: 10.1016/j.gie.2015.08.047. Epub 2015 Sep 3.
Self-expandable metal stent (SEMS) positioning is the recommended method for palliation of dysphagia from esophageal cancer, although it is not adverse event-free. The present study was aimed at identifying predictors for adverse events and at proposing a statistical model to predict them.
We performed a retrospective analysis of a prospectively collected database. All patients who underwent SEMS placement for stricture due to esophageal cancer between 2002 and 2011 in a tertiary-care center were identified. Multivariable regression analysis in the presence of competing risk events was used to identify factors associated with SEMS-related adverse events and to build a prediction model.
A total of 267 patients were included. According to the competing risk regression analysis, only 2 variables were significantly associated with the risk of SEMS-related adverse events: prior chemoradiotherapy (CRT), yielding a hazard ratio (HR) of 1.687 (95% confidence interval [CI], 1.076-2.644), and the SEMS length (HR 0.884; 95% CI, 0.798-0.980) for every 10-mm length increase. Based on the estimated probability curves, after 4 months from SEMS placement, the probability of an adverse event in patients who did receive prior CRT was 50.9% compared with 34.4% in those who did not receive prior therapy, which was reduced to 9.2% and 15.1%, respectively, if a 180 mm-length stent was used. The ability of the predictive model to differentiate between patients who did and did not experience the adverse event was moderate (c-index: 0.617).
The rate of SEMS-related adverse events was higher in patients with previous CRT and lower in patients receiving longer stents. Both factors were used to build an accurate predictive model.
自膨式金属支架(SEMS)定位是治疗食管癌所致吞咽困难的推荐方法,但并非无不良事件。本研究旨在确定不良事件的预测因素,并提出一种统计模型来预测这些事件。
我们对一个前瞻性收集的数据库进行了回顾性分析。在一家三级护理中心,我们确定了所有在 2002 年至 2011 年间因食管癌狭窄而行 SEMS 置入术的患者。在存在竞争风险事件的情况下,采用多变量回归分析来确定与 SEMS 相关不良事件相关的因素,并建立预测模型。
共纳入 267 例患者。根据竞争风险回归分析,只有 2 个变量与 SEMS 相关不良事件的风险显著相关:先前的放化疗(CRT),危险比(HR)为 1.687(95%置信区间[CI],1.076-2.644),以及 SEMS 长度(HR 0.884;95%CI,0.798-0.980),每增加 10mm 长度。根据估计的概率曲线,在 SEMS 放置后 4 个月,接受过 CRT 治疗的患者发生不良事件的概率为 50.9%,而未接受过治疗的患者为 34.4%,如果使用 180mm 长的支架,则分别降低至 9.2%和 15.1%。预测模型区分发生和未发生不良事件的患者的能力为中等(C 指数:0.617)。
先前接受 CRT 的患者 SEMS 相关不良事件发生率较高,而接受较长支架的患者发生率较低。这两个因素都被用来建立一个准确的预测模型。