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; * Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation. * Minimum Barrett*s extent (from Prague criteria) M * 2cm; * 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);
Exclusion criteria
Exclusion criteria: * Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Optical Probe; * Patients with known esophageal strictures, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Optical Probe; * Contraindications for endomucosal resection (EMR) and/or obtaining biopsies (e.g. due to anticoagulation, coagulation disorders, esophageal varices); * Patients within four weeks of receiving targeted forceps biopsies and/or EMR; * Unable to provide signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Can the suspicious regions of interest, which are predicted by VLE-CAD, be targeted by laser marking? Questionnaire analysis using Likert scale: 1-5 b) Feasibility of workflow? Questionnaire analysis using Likert scale: 1-5 | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Diagnostic performance of CAD targeted biopsies (sensitivity, specificity) b) Proportion of VLE-CAD guided biopsies positive for dysplasia, assessed at a per biopsy & per patient level c) Safety - Number of (serious) adverse events related to VLE-CAD guided biopsies d) VLE procedure time, including image acquisition and targeting, not including time for biopsy or resection. e) Total number of VLE-CAD guided biopsies per patient | — |
Countries
Netherlands
Outcome results
None listed