Comparing biopsy methods for monitoring Barrett's Esophagus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: l.c.duits@amsterdamumc.nl
• Phone: +31617741850

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.