The rate of developing a biopsy-bases diagnosis of High-Grade Dysplasia or Esophageal Adenocarcinoma in patients with Barrett*s esophagus, after an extensive baseline evaluation with random biopsies and Wide Area Transepithelial Sample Esophageal brush combined with Computer Assisted 3-Dimensional Tissue Analysis (WATS3D): The WATS-EURO2 Pilot study;The WATS-EURO2 Pilot study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

- Patients age: >= 18 years
- Willingness to undergo both WATS and random forceps biopsies while undergoing
conven-tional EGD with sedation
- Ability to provide written, informed consent (approved by IRB and (biobank
committee)) and understand the responsibilities of trial participation
- BE with a circumferential extent of >=2cm, or a maximum extent of >=4cm, and a
total maxi-mum extent of <=18cm (in case of prior ER: BE length after ER)
- Cohort 1: Patients referred for work-up of LGD, HGD or low-risk cancer (m1 to
sm1, with-out lympho-vascular invasion and poor differentiation), either
diagnosed in random biopsies or in prior endoscopic resection specimen
- Cohort 2: Patients with known, non-dysplastic BE enrolled in endoscopic
surveillance programs

Exclusion Criteria

Exclusion criteria
- Patients with visible lesions according to the Paris classification at the
time of the WATS and random biopsy testing (prior endoscopic resection is
allowed)
- Patients with high-risk cancer after endoscopic resection: either sm2/3
invasion, poor dif-ferentiation, lympho-vascular invasion, or R1 vertical
resection margin
- Patients within six weeks of receiving targeted forceps biopsies and/or ER
- History of esophageal or gastric surgery other than Nissen fundoplication
- History of esophageal ablation therapy
- Coagulopathy with INR >2.0, thrombocytopenia with platelet counts < 50,000
- Subject has a known history of unresolved drug or alcohol dependency that
would limit ability to comprehend or follow instructions related to informed
consent, post-treatment in-structions, or follow-up guidelines

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-The rate of patients with successful inclusion per center and per inclusion day<br /><br><br /><br>-The rate of patients with successful data and sample collection per center and<br /><br>per inclusion day<br /><br><br /><br>-The rate of patients with successful data and sample storage per center and<br /><br>per inclusion day</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-The rate of WATS brushes with sufficient material for an adequate diagnosis<br /><br><br /><br>-The proportion of patients developing HGD/EAC in BE patients after endoscopic<br /><br>removal of visible lesions/or after a confirmed diagnosis of LGD<br /><br><br /><br>-The concordance/discordance for the diagnosis HGD/EAC between random biopsies<br /><br>and WATS brushing collected at the baseline endoscopy and follow-up endoscopies.<br /><br><br /><br>-The rate of progression to HGD/EAC as diagnosed on endoscopic biopsies<br /><br>(targeted or random) or endoscopic resection specimens during a maximum<br /><br>follow-up of 3 years, after a baseline WATS-positive-biopsy negative diagnosis<br /><br>for HGD/EAC.<br /><br><br /><br>-Reproducibility of a positive diagnosis for HGD or cancer in WATS samples on<br /><br>subsequent follow up endoscopies.</p><br>