使用双基因甲基化DNA生物标志物检测法和非内镜球囊在筛查人群中的高危个体中检测巴雷特食管。

Use of a Two-Gene Methylated DNA Biomarker Assay and Nonendoscopic Balloon for Detection of Barrett Esophagus Among High-Risk Individuals in a Screening Population.

作者信息

Shaheen Nicholas J, Othman Mohamed O, Taunk Jawar, Chang Kenneth J, Jaganmohan Sathya, Yachimski Patrick S, Fang John C, Spataro Joseph S, Verma Suman, Lee Victoria T, deGuzman Brian J, Aklog Lishan

机构信息

Division of Gastroenterology and Hepatology, Center for Esophageal Diseases and Swallowing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Gastroenterology and Hepatology Section, Baylor College of Medicine, Houston, Texas, USA.

出版信息

Am J Gastroenterol. 2024 Nov 26;120(7):1511-1520. doi: 10.14309/ajg.0000000000003238.

DOI:10.14309/ajg.0000000000003238

PMID:39588974

Abstract

INTRODUCTION

Barrett esophagus (BE) is the precursor to esophageal adenocarcinoma (EAC). We aimed to assess performance, safety, and tolerability of the EsoGuard (EG) assay on samples collected nonendoscopically with the EsoCheck (EC) device (EG/EC) for BE detection in the intended-use population meeting American College of Gastroenterology guideline criteria (chronic gastroesophageal reflux disease and 3+ additional risk factors).

METHODS

We performed a prospective, multicenter study (NCT04293458) to assess EG performance (primary endpoint) on cells collected with EC, for detection of BE and EAC using esophagogastroduodenoscopy (EGD) and biopsies as the comparator. Twenty-four sites across the United States and Spain participated. EC safety and usability were assessed as secondary endpoints.

RESULTS

180 male subjects aged >50 years with chronic gastroesophageal reflux disease met eligibility criteria, of which 163 (90.6%) had EGD and successful EC administration. Mean age was 60.5 years, 34.4% were obese, 56.7% had tobacco history, and 3.9% had a 1st degree relative with BE or EAC. Of 122 samples analyzed, 93 contributed to the primary endpoint analysis. Eight subjects (8.6%) in the Primary Analysis Population had BE on EGD, none with dysplasia. Sensitivity of EG for BE was 87.5% (95% confidence interval [CI] 47.4-99.7), specificity was 81.2% (95% CI 71.2-88.8), positive predictive value was 30.4% (95% CI 13.2-52.9), and negative predictive value was 98.6% (95% CI 92.3-99.96). Mild esophageal abrasions were observed in 1.5%; no serious adverse events were reported.

DISCUSSION

This study in the intended-use population suggests that EG/EC is promising for BE screening. While future work is necessary to define its performance characteristics with more precision, this approach may provide a safe, accurate, and well-tolerated nonendoscopic alternative in high-risk patients.

摘要

引言

巴雷特食管（BE）是食管腺癌（EAC）的癌前病变。我们旨在评估EsoGuard（EG）检测法对使用EsoCheck（EC）装置非内镜采集的样本检测BE的性能、安全性和耐受性，该检测针对符合美国胃肠病学会指南标准（慢性胃食管反流病及3个以上额外风险因素）的目标人群。

方法

我们开展了一项前瞻性多中心研究（NCT04293458），以评估EG对通过EC采集的细胞检测BE和EAC的性能（主要终点），并以食管胃十二指肠镜检查（EGD）及活检作为对照。美国和西班牙的24个研究点参与了研究。EC的安全性和易用性作为次要终点进行评估。

结果

180名年龄大于50岁的患有慢性胃食管反流病的男性受试者符合入选标准，其中163名（90.6%）接受了EGD检查且成功进行了EC检测。平均年龄为60.5岁，34.4%为肥胖者，56.7%有吸烟史，3.9%有一级亲属患有BE或EAC。在分析的122份样本中，93份纳入主要终点分析。主要分析人群中有8名受试者（8.6%）在EGD检查中发现患有BE，均无发育异常。EG检测BE的敏感性为87.5%（95%置信区间[CI]47.4 - 99.7），特异性为81.2%（95%CI 71.2 - 88.8），阳性预测值为30.4%（95%CI 13.2 - 52.9），阴性预测值为98.6%（95%CI 92.3 - 99.96）。观察到1.5%的受试者有轻度食管擦伤；未报告严重不良事件。