Clinical trial · 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Diagnosis | — | UNRESOLVED | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WATS3D | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- cohort 1 dysplastic cohort
- description
- 208 BE patients referred for work up after diagnosis of LGD, HGD or earlystage cancer in the last 18 months.
- interventionNames
- Diagnostic Test: WATS3D
- label
- Cohort 2: non-dysplastic cohort
- description
- 208 patients under standard BE surveillance without a diagnosis of dysplasia in last 18 months.
- interventionNames
- Diagnostic Test: WATS3D
Primary outcomes (1)
- measure
- HGD/EAC
- timeFrame
- 3 years after last inclusion
- description
- The concordance/discordance for the diagnosis HGD/EAC between random biopsies and WATS brushings collected at the baseline endoscopy and follow-up endoscopies.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available