Ireland
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Recruiting Observational

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

NCT05642338 · tracked via the Priya Life Science Netherlands tracker
Phase
Observational
Started
2022-11-01
Last updated
2022-12-08

Condition(s) studied

Barrett EsophagusEsophageal AdenocarcinomaDiagnosis

Investigational drug(s) / intervention(s)

WATS3D

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • HGD/EAC — 3 years after last inclusion
    The concordance/discordance for the diagnosis HGD/EAC between random biopsies and WATS brushings collected at the baseline endoscopy and follow-up endoscopies.

Trial sites (1)

FacilityCityRegionStatus
Amsterdam University Medical Centre, loc. VUmc Amsterdam North Holland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05642338 on ClinicalTrials.gov ↗ ← All trials in the Netherlands