A Multicenter Randomized Trial of Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients with Barrett's Esophagus Undergoing Surveillance (The SWAT-BE Study)

Primary Objective

Primary Outcome Measures: 1. Diagnostic yield of dysplasia (Surveillance population only) [ Time Frame: up to 1 year ] 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. 2. Diagnostic yield of intestinal metaplasia (Screening population only) [ Time Frame: up to 1 year ] Proportion of positive results between the Seattle protocol and WATS3D technique. Positive results include intestinal metaplasia. All positive results for intestinal metaplasia/dysplasia or esophageal adenocarcinoma (EAC) with WATS3D sampling not detected on Seattle biopsy protocol at index endoscopy will require confirmation by repeat sampling using the Seattle biopsy protocol. Secondary Outcome Measures: 1. Detection of intestinal metaplasia (Surveillance population only) [ Time Frame: baseline ] 2. Diagnostic yield between the Seattle protocol and WATS3D Vs. the Seattle protocol alone (Surveillance population only) [ Time Frame: up to 1 year ] 3. Time of procedure as measured by total sampling time (Surveillance population only) [ Time Frame: baseline ] 4. Quality adjusted life years (Surveillance population only) [ Time Frame: up to 5 years ] 5. Number of patients referred for endoscopic eradication therapy (EET) between Seattle protocol and WATS3D (Surveillance population only) [ Time Frame: up to 1 year ] 6. Interobserver agreement among pathologists for WATS3D specimens (Surveillance population only) [ Time Frame: up to 6 months ] 7. Predictors of dysplasia in patients with non-dysplastic BE (Surveillance population only) [ Time Frame: up to 5 years ] 8. Counts of participants with a biomarker or panel of biomarkers associated with increased risk of progression [ Time Frame: up to 5 years ] 9. Diagnostic yield of dysplasia (Screening population only) [ Time Frame: up to 1 year ]

Is this Study for You?

Let's Get Started!

Details
Age

Adult

Type of Study

Screening

Scope

National

Locations

Kaiser Permanente of Colorado
Mayo Clinic, Arizona
UCLA, Jonsson Cancer Center
University of Colorado Hospital
University of Michigan

Principal Investigator
Photograph of Sachin Wani,  MD

Sachin Wani, MD

Study ID

Protocol Number: 18-2431

More information available at ClinicalTrials.gov: NCT05530343

Is this Study for You?

Let's Get Started!

Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers