A Multicenter Randomized Trial Comparing Seattle Biopsy Protocol and Wide-Area Transepithelial Sampling in Patients With Barretts Esophagus Undergoing Surveillance

What this Trial Is About

Researchers are evaluating the best way to sample patients with known or suspected Barretts esophagus BE, a condition that increases the risk of esophageal adenocarcinoma, a type of esophageal cancer. The study compares the standard Seattle biopsy protocol to a newer method called wide area transepithelial sampling WATS3D. Early detection of precancerous changes called dysplasia is critical to prevent cancer, and this trial aims to determine which sampling method is more effective for identifying these changes. Participants undergo an upper endoscopy procedure using high-definition white light and electronic chromoendoscopy to detect visible abnormalities. They are randomly assigned to receive either the Seattle biopsy protocol, which takes tissue samples every 2 cm in four quadrants plus targeted areas, or the WATS3D brushings, which collect samples from every 5 cm segment of Barretts esophagus. Each participant receives both sampling methods in a randomized order during the same procedure. If results differ, a repeat endoscopy with the Seattle biopsy protocol is done to confirm findings. During the study, participants will have tissue samples examined by expert pathologists blinded to patient details and prior results. Researchers will assess the diagnostic yield of dysplasia and intestinal metaplasia up to one year after sampling. They will also monitor progression to dysplasia, cancer, need for treatment, and death. The study involves approximately 2700 participants across multiple centers and includes follow-up for up to five years to evaluate long-term outcomes and quality of life.

Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance