Background: While rates of Esophageal Adenocarcinoma (EAC) in the US continue to rise, many patients at risk of disease are not screened. EsoCheck (EC), a non-endoscopic esophageal balloon sampling device coupled with EsoGuard (EG), a DNA based screening assay, is an FDA-approved minimally invasive alternative to the traditional screening method of upper endoscopy. Aim: Aim To prospectively determine the diagnostic accuracy, tolerance, and acceptability of the EC/EG test in a screening population. Methods: We recruited Veterans who met the American College of Gastroenterology (ACG) Guideline criteria for endoscopic Barrett's Esophagus (BE) and EAC screening at Louis Stokes Cleveland Veteran Affairs Medical Center. All study participants completed unsedated EC guided distal esophageal sampling followed by a sedated esophagogastroduodenoscopy (EGD). Diagnostic yield of the EG assay and EGD was recorded and used in calculation of sensitivity and specificity of EC/EG in prospective screening. The abbreviated Spielberger State-Trait Anxiety Inventory (STAI-6) questionnaire was administered before and after completion of EC. Overall tolerance of EC sampling was evaluated on a 10-point Likert scale. Results: Results Esophageal cancer screening was accepted by 130/782 (16.6%) eligible veterans and we analyzed results of those who completed both screening tests (N = 124). Prevalence of BE/EAC among studied veterans was 12.9% (16/124), based on EGD. Sensitivity and specificity of EC/EG for EGD-detected BE/EAC were 92.9% (95% CI 66.1, 99.8) and 72.2% (95% CI 62.1, 80.8), respectively. Positive and negative predictive values were 32.5% (95% CI 18.6, 49.1) and 98.6% (95% CI 92.4, 100), respectively. Baseline STAI-6 scores were reflective of notable levels of anxiety among veterans in the peri-procedural setting. Mean post-procedure acceptability score for Esocheck test was 7.23 (SD 2.45). Conclusions: Conclusions Our data suggest excellent sensitivity and negative predictive value of EC/EG in a screening population of veterans, making this modality a powerful screening tool for BE and EAC.

Dr Amitabh Chak has a patent on use of methylated vimentin for detection of GI cancers and a patent on Esocheck/Esoguard device. The contents presented here do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

This study was funded by DOD Award W81XWH2110586. Study is registered at Clinicaltrials.gov NCT05210049.

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Ethics committee/IRB at the Louis Stokes VA Medical Center and USA MRDC Office of Human and Animal Research Oversight gave ethical approval for this work.

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