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RECRUITING
NCT05642338

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

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

Summary

The investigators aim to study the rate of developing a biopsy-based diagnosis of high-grade dysplasia (HGD) and EAC in BE patients in a prospective cohort of 208 BE patients at high risk of progression (i.e. after endoscopic removal of visible lesions containing HGD/EAC and/or a diagnosis of low-grade dysplasia (LGD)) as well as in 208 BE patients with a nondysplastic BE (NDBE) undergoing standard BE surveillance. In these patients the investigators will combine biopsy sampling with WATS at baseline and all follow-up endoscopies during a 3- year follow-up period. This will allow us to study the natural history of WATS-positive-biopsynegative- cases and of WATS-specific outcomes such as basal-crypt dysplasia. The study also allows us to collect specimens for future biomarker studies that may help to predict progression to HGD/EAC in the absence of morphological features of dysplasia.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

416

Start Date

2022-11-01

Completion Date

2027-05-01

Last Updated

2022-12-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

WATS3D

the WATS3D brush samples the esophagus by abresing the tissue. the brush is directed through the workingchanel of endoscope into the oesophagus

Locations (1)

Amsterdam University Medical Centre, loc. VUmc

Amsterdam, North Holland, Netherlands