Comparing biopsy methods for monitoring Barrett's Esophagus

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

This study is testing whether a new biopsy method called WATS is better than the usual random biopsies for monitoring patients with Barrett's Esophagus who are at high risk for serious complications.

Quick facts

• Study type: Observational
• Enrollment: 416 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other)
• Locations: 1 site (Amsterdam, North Holland)
• Trial ID: NCT05642338 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of wide-area transepithelial brush-sampling (WATS) compared to traditional random biopsies in monitoring Barrett's Esophagus (BE) patients at high risk for progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). It involves a cohort of 416 BE patients, with half having a history of dysplasia and the other half being nondysplastic, over a three-year follow-up period. The study aims to assess the natural history of WATS-positive, biopsy-negative cases and collect specimens for future biomarker research. The goal is to improve surveillance strategies and enhance early detection of EAC.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with Barrett's Esophagus, either with a history of dysplasia or enrolled in surveillance programs.

Not a fit: Patients with visible lesions or high-risk cancer after endoscopic resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection of esophageal adenocarcinoma, potentially reducing mortality rates.

How similar studies have performed: Previous studies have shown promise in using similar brush-sampling techniques for improved detection rates in Barrett's Esophagus surveillance.

Eligibility criteria

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

Where this trial is running

Amsterdam, North Holland

• Amsterdam University Medical Centre, loc. VUmc — Amsterdam, North Holland, Netherlands (RECRUITING)

Study contacts

• Principal investigator: prof Bergman, MD, PhD — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Study coordinator: Pim Stougie

Conditions: Barrett Esophagus, Esophageal Adenocarcinoma, Diagnosis, detection, WATS3D, forceps Biopsies, Dysplasia