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

Proportion of positive results between the Seattle protocol and WATS3D technique. Positive results include intestinal metaplasia.

Proportion of positive results of low-grade dysplasia (LGD), high-grade dysplasia (HGD), and esophageal adenocarcinoma (EAC) between the Seattle protocol and WATS3D technique Vs. the WATS3D technique alone. All positive results for intestinal metaplasia/dysplasia or EAC with WATS3D sampling not detected on Seattle biopsy protocol at index endoscopy will require confirmation by repeat sampling using the Seattle biopsy protocol.

Total sampling time for the Seattle protocol is measured by the time the first forceps biopsy was placed into the channel to the time the final forceps biopsy was removed from the channel. Total sampling time for the WATS3D technique is measured by the time the first WATS3D brush was placed into the channel to the time the final WATS3D brush was removed from the channel.

The investigators will conduct a cost-effectiveness analysis between the two sampling techniques using data collected from the randomized control trial (cost for procedures and follow-up, detection of dysplasia or cancer, need for endoscopic eradication therapies, biopsy and pathology costs, complications, among others). The primary endpoint for the cost-effectiveness analysis will be the incremental cost-effectiveness ratio with a predefined willingness to pay off $100k per quality adjusted life years.

Proportion of patients referred for endoscopic eradication therapy (EET) in patients positive only on Seattle biopsy protocol for low-grade dysplasia (LGD), high-grade dysplasia (HGD), or esophageal adenocarcinoma (EAC) compared to proportion of patients referred for EET in patients positive only on WATS3D. All positive results for intestinal metaplasia/dysplasia or EAC with WATS3D sampling not detected on Seattle biopsy protocol at index endoscopy will require confirmation by repeat sampling using the Seattle biopsy protocol.

Interobserver agreement among pathologists with be assessed using Kappa statistics.

Clinical and endoscopic variables collected as a part of the SWAT-BE study will be utilized to identify predictors associated with increased risk of progression to dysplasia or esophageal adenocarcinoma (EAC).

Specimens collected during the SWAT-BE study (WATS3D specimens) will be analyzed for biomarkers for improved risk stratification (i.e., identify patients at increased risk of progression to high-grade dysplasia or esophageal adenocarcinoma).

Proportion of positive results between the Seattle protocol and WATS3D technique. Positive results include low-grade dysplasia (LGD), high-grade dysplasia (HGD), and esophageal adenocarcinoma (EAC). All positive results for dysplasia or EAC with WATS3D sampling not detected on Seattle biopsy protocol at index endoscopy will require confirmation by repeat sampling using the Seattle biopsy protocol.