Barrett's esophagus dysplasia
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients age: >= 18 years - BE with a circumferential extent of >=2cm and a total 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To study the concordance/discordance between random biopsies and WATS brushing collected at the baseline endoscopy and at follow-up endoscopies for the diagnosis HGD/EAC. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To study the rate of progression to HGD/EAC in endoscopic biopsies (targeted or random) or endoscopic resection specimens during follow-up, after any prior WATS-positive-biopsy-negative diagnosis for HGD/EAC. - To study the rate of HGD/EAC (biopsy diagnosed) in BE patients at high risk of progression (i.e. after endoscopic removal of visible lesions containing HGD/EAC and/or a diagnosis of LGD) and in BE patients undergoing standard endoscopic surveillance. - To study the concordance/discordance between random biopsies and WATS brushing collected at the baseline endoscopy and at follow-up endoscopies for the diagnosis intestinal metaplasia. - To study the rate of diagnosing intestinal metaplasia in endoscopic biopsies during follow-up, after a baseline WATS-positive-biopsy-negative diagnosis for intestinal metaplasia. - To evaluate the rate of progression to HGD/EAC in endoscopic biopsies (targeted or random) or endoscopic resection specimens during follow-up, after a baseline diagnosis WATS3D brush crypt dysplasia diagnosis. - To assess whether a positive finding of HGD/EAC using the WATS system is reproducible on subsequent endoscopies. | — |
Countries
Netherlands
Outcome results
None listed