1) Barrett's oesophagus 2) early oesophageal cancer
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - age over 18 years - patients referred with Barrett's oesophagus with and without early neoplasia - written informed consent
Exclusion criteria
Exclusion criteria: - patients with a condition precluding full distension of the N-Vision balloon, such as strictures or a mass - inability to obtain biopsies (e.g. due to antocoagulation therapie, coagulation disorder, varices) - eosophillic oesophagitis - pregnancy - unable to provide signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 1) feasibility of the system 2) the capacity of the system to construct a high-resolution map of the mucosal lining of the oesophagus 3) the capacity of detecting areas suspicious for neoplasia (by correlating the suspicious areas identified by the N-Vision system to the histological diagnosis of the biopsy specimen of that particular area). Phase 2 1) sensitivity and specificity of the pVLE system for the detection of early neoplasia in BE 2) additional value of the pVLE system over the assessment of the endoscopist alone. | — |
Countries
Netherlands
Outcome results
None listed