A multicenter prospective cohort study comparing random biopsies with Wide-Area Transepithelial brush-Sampling (WATS) for surveillance of Barrett*s esophagus.;The WATS-EURO2 study

Recruiting

• Conditions: Barrett's esophagus; dysplasia; 10017990

• Registration Number: NL-OMON53667
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 239

Inclusion Criteria

- Patients age: >= 18 years
- BE with a circumferential extent of >=2cm and a total maximum extent of <=18cm
(in case of prior ER: BE length is measured after ER). Or a circumferential
extent of 0-1 cm with a maximum extent of >=4cm.
- Cohort 1: Patients referred for work-up of IND, LGD, HGD or low-risk cancer
(m1 to sm1, without lympho-vascular invasion and poor differentiation), either
diagnosed in random biopsies or in prior endoscopic resection specimen within
18 months prior to baseline endoscopy
- Cohort 2: Patients with known BE without a diagnosis of dysplasia in the last
18 months, enrolled in endoscopic surveillance programs
- Ability to give written, informed consent and understand the responsibilities
of participation

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 differentiation, lympho-vascular invasion, or R1 vertical
resection margin
- Patients within six weeks after endoscopy with biopsies and/or ER
- History of esophageal or gastric surgery other than Nissen fundoplication
- History of esophageal ablation therapy
- Presence of esophageal varices
- 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 instructions, or follow-up guidelines

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To study the concordance/discordance between random biopsies and WATS<br /><br>brushing collected at the baseline endoscopy and at follow-up endoscopies for<br /><br>the diagnosis HGD/EAC.</p><br>