Barrett esophagus with and without neoplasia
Conditions
Interventions
Endoscopy as planned for routine clinical care, where VLE algorithm targeted biopsies are evaluated for the detection of BE neoplasia
Sponsors
Top Sector Life Sciences & Health: Health Holland & TKI, NinePoint Medical
Eligibility
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 |
|---|---|
| Feasibility of a real-time VLE computer algorithm for the detection of BE neoplasia | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Diagnostic performance of CAD targeted biopsies (accuracy, sensitivity, specificity) b) Proportion of VLE-CAD guided biopsies positive for dysplasia, assessed at a per biopsy & per patient level c) Safety d) VLE procedure time e) Total number of VLE-CAD guided biopsies per patient | — |
Contacts
Public ContactMaarten Struyvenberg
UMC Amsterdam, locatie AMC
Outcome results
None listed