Department of Gastroenterology and Hepatology, University Medical Center Amsterdam, Amsterdam, the Netherlands.
Cernostics, Inc., Pittsburgh, Pennsylvania, USA.
Clin Transl Gastroenterol. 2020 Oct;11(10):e00244. doi: 10.14309/ctg.0000000000000244.
An automated risk prediction assay has previously been shown to objectively identify patients with nondysplastic Barrett's esophagus (NDBE) who are at increased risk of malignant progression. To evaluate the predictive performance of the assay in 76 patients with NDBE of which 38 progressed to high-grade dysplasia/esophageal adenocarcinoma (progressors) and 38 did not (nonprogressors) and to determine whether assessment of additional (spatial) levels per endoscopy and/or multiple (temporal) time points improves assay performance.
In a blinded, nested case-control cohort, progressors and nonprogressors were matched (age, sex, and Barrett's esophagus length). All random biopsy levels from the baseline endoscopy (spatial samples) and all available previous endoscopies back to 10 years before progression (temporal samples) were assayed. Because the 1:1 ratio of progressors to nonprogressors does not reflect the real-world Barrett's population, negative and positive predictive values were adjusted for prevalence.
Seventy-six patients (58 men), mean age of 63 ± 9 years, were studied. A high-risk score was associated with a prevalence-adjusted annual progression rate of 6.9%. The assay identified 31% of progressors when assessing a single biopsy level from the baseline endoscopy. Sensitivity increased to 50% and 69% in spatial and temporal analyses, respectively, while specificity remained at 95%.
The assay identified a significant subset of NDBE patients who progress at a rate comparable with published estimates for expert-confirmed low-grade dysplasia. Assessing additional spatial and temporal biopsies increased the predictive accuracy, allowing for identification of most future progressors. Additional studies will evaluate the predictive performance of the assay in low-prevalence settings.
先前已经证明，一种自动化的风险预测检测可以客观地识别出非异型性 Barrett 食管（NDBE）患者，这些患者恶性进展的风险增加。为了评估该检测在 76 例 NDBE 患者中的预测性能，其中 38 例进展为高级别异型增生/食管腺癌（进展者），38 例未进展（非进展者），并确定是否评估内镜下额外（空间）水平和/或多次（时间）时间点可以提高检测性能。
在一项盲目的嵌套病例对照队列研究中，进展者和非进展者按年龄、性别和 Barrett 食管长度进行匹配。对基线内镜检查的所有随机活检水平（空间样本）和所有可获得的以前内镜检查结果（回溯至进展前 10 年）进行检测。由于进展者与非进展者的 1:1 比例不能反映真实世界的 Barrett 人群，因此对阴性和阳性预测值进行了患病率调整。
研究了 76 例患者（58 例男性），平均年龄为 63 ± 9 岁。高风险评分与患病率调整后的年进展率为 6.9%相关。当评估基线内镜检查的单个活检水平时，该检测识别出 31%的进展者。在空间和时间分析中，敏感性分别增加到 50%和 69%，而特异性仍保持在 95%。
该检测识别出了一个重要的 NDBE 患者亚组，其进展速度与发表的经专家确认的低级别异型增生的估计值相当。评估额外的空间和时间活检增加了预测准确性，使大多数未来的进展者得以识别。进一步的研究将评估该检测在低患病率环境中的预测性能。
