通过 EsoGuard® 分诊提高胃肠造影诊断巴雷特食管的阳性预测值

Jayde E Kurland, Sheena B Patel, Richard Englehardt, Seper Dezfoli, Daniel M Tseng, Michael W Foutz, Paul S Bradley, Badi Eghterafi, Victoria T Lee, Suman Verma, Brian J deGuzman, Lishan Aklog
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摘要

背景:指南支持巴雷特食管(BE)筛查,但大多数符合条件的患者并不接受内镜评估;美国胃肠病学会现在支持将非内镜策略作为一种合理的替代方法。EsoGuard(EG)是一种 DNA 检测方法,与 EsoCheck(一种用于检测 BE 的非内镜细胞收集装置)一起使用,可作为符合筛查标准的患者进行食管胃十二指肠镜检查(EGD)的分流方法。这样,EG 可以丰富接受 EGD 检查的人群,从而获得更多的 BE 诊断结果,同时有可能降低本已有限的内镜检查资源的利用率。目的:验证一个假设,即在对 EG 阳性患者进行的 EGD 检查中,BE 的检出率将显著高于单纯筛查 EGD 的阳性预测值 (PPV)。方法从有胃肠造影诊断的 EG 阳性患者中回顾性收集真实世界数据。从主治医生处获得患者的基线特征、风险因素和胃肠造影结果。以 EGD 筛查的 PPV 为参照,并根据文献中确定的 BE 患病率进行估算,美国胃食管反流病患者的患病率约为 10.6%。假设采用单侧 5%显著性水平的单一比例 t 检验进行检验。结果:来自 209 名患者的数据发现,有 60 人(28.7%)在胃肠造影检查中发现鲑鱼色粘膜,在组织病理学检查中发现专门的肠化生。但是,有 10 例(4.8%)目测病变直径为 1 厘米,因此不符合美国胃肠病学院对 BE 的定义,被排除在分析之外。在剩余的 199 名患者中,有 50 人(25.1%)的胃肠造影检查结果为 BE。在符合 ACG 筛查标准的患者中,28.9%(33/114)患有 BE。总体而言,与 EGD 筛查的 PPV 相比,BE 的检出率提高了 2.4 倍,而在 ACG 群体中,这一提高幅度为 2.7 倍。在≥65岁的ACG患者中,这一增幅接近2.5倍(检出率为25.9%):我们的数据表明,作为一项分流检查,EG 和 EC 可使接受 EGD 检查的 BE 患者更加丰富,与单独进行 EGD 筛查相比,EG 和 EC 可帮助更有效地利用内镜检查资源,在不减少符合筛查和诊断条件的患者数量的情况下减轻系统负担。
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Enhancing the Positive Predictive Value of EGD for Diagnosis of Barrett's Esophagus Through EsoGuard® Triage
Background: Guidelines support Barrett's esophagus (BE) screening, but most eligible patients do not undergo endoscopic evaluation; non-endoscopic strategies are now supported as a reasonable alternative by U.S gastroenterology societies. EsoGuard (EG) is a DNA assay used with EsoCheck, a non-endoscopic cell collection device for detection of BE, which can be utilized as a triage to esophagogastroduodenoscopy (EGD) in patients meeting screening criteria. In doing so, EG may serve to enrich the population undergoing EGD, resulting in more BE diagnoses while potentially reducing utilization of already-limited endoscopy resources. Aim: To test the hypothesis that BE detection in EGDs performed on EG positive patients will be significantly higher than the positive predictive value (PPV) of screening EGD alone. Methods: Real-world data was retrospectively collected from EG positive patients for whom EGD diagnoses were available. Baseline patient characteristics, risk factors, and EGD results were obtained from the treating physicians. PPV of screening EGDs was the comparator and estimated by literature-established disease prevalence of BE, which in the U.S gastroesophageal reflux disease population is ~10.6%. The hypothesis was tested using t-tests for single proportions at a one-sided 5% significance level. Results: Data from 209 patients found 60 (28.7%) subjects with salmon-colored mucosa on EGD and specialized intestinal metaplasia on histopathology. However, 10 (4.8%) had < 1cm of disease on visual inspection, therefore, did not meet the American College of Gastroenterology definition of BE so was excluded from the analysis. Of the remaining 199 patients, 50 (25.1%) had BE on EGD. In the cohort of patients meeting ACG screening criteria, 28.9% (33/114) had BE. Overall, a 2.4-fold increase in BE detection was observed compared to the PPV of screening EGD, and in the ACG cohort this increase was 2.7-fold. Among ACG patients ≥65 years old, the increase was nearly 2.5-fold (25.9% detection rate). Conclusions: Our data suggests EG and EC used as a triage test enriches the population undergoing EGD for BE, and compared to screening EGD alone, can help direct more efficient use of endoscopy resources to unburden the system without reducing the number of eligible patients screened and diagnosed.
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