Barrett Esophagus dysplasia
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Patients age: >= 18 years - BE with a maximal extent of >=4cm - Cohort 1: Patients referred for endoscopic treatment of HGD or EAC - Cohort 2: Patients with known BE without a diagnosis of HGD or EAC in the previous 18 months, undergoing endoscopic surveillance - Ability to give written, informed consent and understand the responsibilities of participation
Exclusion criteria
Exclusion criteria: • Patients within eight weeks after endoscopy with biopsies and/or ER • History of esophageal or gastric surgery other than Nissen fundoplication • History of esophageal ablation or dilation therapy • Presence of esophageal varices and/or suspected portal hypertension • pregnancy • present Dysphagia/ swallowing disorders at the time of screening and participation • Patients with known or suspected anatomical abnormalities of the esophagus or stomach • Patients taking anti-thrombotic drugs that cannot be temporarily discontinued • 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 |
|---|---|
| The amount of samples collected with the Cytosponge that contain columnar cells and are processed to clot preparations that are at least 5mm in size. | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of successful Cytosponge study procedures. The concordance between the pathology review of endoscopic samples and samples collected with the Cytosponge The concordance between 2 samples of the same subject taken with the Cytosponge | — |
Countries
Netherlands