Barrett's esophagus early esophageal cancer
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age > 18 years; - Known BE, defined as columnar lined epithelium of the esophagus containing intestinal metaplasia upon biopsy, with or without dysplasia (low-grade or high-grade dysplasia or early adenocarcinoma); - Signed informed consent.
Exclusion criteria
Exclusion criteria: - Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Optical Probe; - Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Optical Probe; - Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Optical Probe; - Contraindications for ER and/or obtain biopsies (e.g. due to anticoagulation, coagulation disorders, esophageal varices); - Previously treated dysplasia by either ER and/or ablation therapy; - Unable to provide signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Per area and per patient analysis of diagnostic accuracy of both the VLE prediction score and the VLE computer algorithm. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Inter-observer agreement of the VLE prediction score - Identification of additional in-vivo clinical features predictive of early neoplasia - Time to analyse a complete VLE scan using the VLE prediction score; - Time to analyse a complete VLE scan using the computer algorithm. | — |
Countries
Netherlands
Outcome results
None listed