Detection of high-grade dysplasia and adenocarcinoma in Barrett's esophagus using high-resolution virtual...

Barrett's esophagus (BE) is a pre-cancerous condition with an increased risk of esophageal adenocarcinoma (EAC). Current surveillance involves white light endoscopy with random biopsies (Seattle Protocol, SP) but has limitations. This study explores high-resolution virtual chromoendoscopy (HRMC) as a potential alternative.

This controlled trial will enroll 110 patients with Barrett's esophagus (BE) across 15 gastroenterology departments in France. Each patient will undergo both HRMC and SP examinations during the same endoscopic procedure. Although the trial is non-randomized, it is important to highlight that the two endoscopists performing either the HRMC or the SP will be blinded to each other's results. Therefore, each patient will serve as their own control. Biopsy decisions will be based on both methods, with any visible lesions resected. The primary objective is to compare the detection rate of HGD and EAC lesions using HRMC with targeted biopsies versus SP with random biopsies. Secondary objectives include comparing detection rates of LGD lesions, procedure time, missed lesions, and cost-effectiveness.

If HRMC proves superior to SP for detecting HGD and EAC, it could lead to more accurate, efficient, and cost-effective BE surveillance strategies, improving patient outcomes and resource utilization.

ClinicalTrials.gov NCT05229783 - First Submitted 2021-12-07.