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)
Study ID
NCT05642338
Status
Recruiting
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Conditions

  • Barrett Esophagus
  • Diagnosis
  • Esophageal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

First listed
Dec 8, 2022
Start date
Nov 1, 2022
Status verified
Dec 2022
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
416 participants (estimated)

Arms

  • Arm: cohort 1 dysplastic cohort
    208 BE patients referred for work up after diagnosis of LGD, HGD or earlystage cancer in the last 18 months.
  • Arm: Cohort 2: non-dysplastic cohort
    208 patients under standard BE surveillance without a diagnosis of dysplasia in last 18 months.

Primary Outcome Measure

HGD/EAC [ Time Frame: 3 years after last inclusion ]

Central Contacts

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