Pilot study of EsoCheck/EsoGuard for detecting Barrett's esophagus in high-risk patients undergoing hiatal hernia...

Esophageal adenocarcinoma (EAC) has poor survival outcomes, yet population-level screening remains limited. EsoCheck, a swallowable balloon device paired with the EsoGuard DNA methylation assay, is a minimally invasive screening tool for Barrett's esophagus (BE), a precursor to EAC. Hiatal hernia is a strong risk factor for BE. This pilot study provides preliminary insight into the diagnostic performance of intraoperative EsoCheck/EsoGuard compared with upper endoscopic biopsies for screening patients undergoing hiatal hernia repair.

This prospective cross-sectional study was conducted at a single institution. Eligible participants were aged ≥ 18, had a diagnosis of GERD, and were undergoing BE screening or surveillance followed by planned hiatal hernia repair. Exclusion criteria included a history of esophageal malignancy or surgery. Patients were placed under general anesthesia for sample collection, followed by hiatal hernia repair. Distal esophageal samples collected via EsoCheck and upper endoscopy were analyzed by the EsoGuard assay and histopathology, respectively.

28 patients underwent successful sample collection and hernia repair. Mean BMI was 28.6 ± 6.2 and mean age was 56.9 ± 14.9 years. Patients were 71% women, 79% White, 36% obese, and 39% had a history of smoking. Mean number of risk factors per patient based on ACG guidelines was 3.5 ± 1.1. BE was detected in 6 (21%) patients, with 3 being short-segment BE (< 3 cm). EsoGuard showed sensitivity of 83.3% (95% CI 35.9-99.6) and specificity of 63.6% (95% CI 40.7-82.8). Positive predictive value was 38.5% (95% CI 24.4-54.7) and negative predictive value was 93.3% (95% CI 69.5-98.9). Of the 8 patients with false-positive EsoGuard results, 5 had chronic inflammatory mucosal changes on pathology. No complications were associated with EsoCheck sampling.

EsoCheck/EsoGuard demonstrates high sensitivity and meets the criteria for a screening tool for BE. Given its low specificity, positive results mandate a confirmatory test, such as upper endoscopy with biopsies.