Comparing Random Biopsies and Wide-Area Brush-Sampling for Barretts Esophagus Surveillance A Multicenter Prospective Study on Detection of High-Grade Dysplasia and Esophageal Adenocarcinoma

What this Trial Is About

Researchers are investigating the development of high-grade dysplasia HGD and esophageal adenocarcinoma EAC in patients with Barretts Esophagus BE. This study compares the traditional random biopsy method with a new Wide-Area Transepithelial Brush-Sampling WATS technique to improve detection during surveillance. The study focuses on two groups those at high risk after removal of visible lesions or low-grade dysplasia and those under routine BE surveillance without dysplasia. Participants will undergo baseline and follow-up endoscopies over three years where both random biopsies and WATS brushings are performed. The WATS brush samples cells from all epithelial layers using a specialized cytology brush passed through the endoscope. This method is being studied for its potential to detect dysplasia earlier and more thoroughly than traditional biopsies. Samples collected will also support future biomarker research to better predict disease progression. During the study, participants will have regular endoscopic exams with combined biopsy and brush sampling to monitor for the appearance of HGD or EAC. Researchers will analyze biopsy results, WATS findings, and patient outcomes over the three-year follow-up. Safety and procedure effectiveness will be assessed, and the study allows for specimen collection to explore new diagnostic markers. The total participation duration is three years, with ongoing monitoring to understand the natural history of cases identified by WATS but not by biopsy.

A Multicenter Prospective Cohort Study Comparing Random Biopsies Versus Wide-Area Transepithelial Brush-Sampling (WATS) for Surveillance of Barrett's Esophagus, the WATS-EURO2 Study