Barrett's esophagus early neoplasia advanced imaging Barrett slokdarm vroege neoplasie
Conditions
Interventions
The study uses the VLE catheter to examine and scan the distal Barrett's esophagus. VLE is an advanced imaging technique that has the potential to better visualize early neoplasia in Barrett's esophag
Sponsors
AMC Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females over the age of 18 years; 2. Patients with either suspected or confirmed Barrett’s-associated dysplasia or intramucosal adenocarcinoma presenting for endoscopy likely requiring EMR; 3. Patients with non-dysplastic Barrett’s oesophagus; 4. Eligible for endoscopic resection of Barrett mucosa; 5. Ability to provide written, informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with a condition precluding full distension of the N-Vision balloon, such as strictures or a mass; 2. Inability to obtain biopsies and/or EMR (e.g. due to antocoagulation therapie, coagulation disorder, varices); 3. Eosophillic oesophagitis; 4. Oesophagitis > LA grade A; 5. Pregnancy; 6. Unable to provide signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the correlation of features seen on VLE images to those seen on histopathology from mucosal resection specimens. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint will be the following: The creation of an image atlas, which will be used to determine the intra and inter observer agreement on VLE images in correlation with histopathology, resulting in refinement of the existing VLE image interpretation criteria and the validation of the VLE classification. | — |
Contacts
Public ContactJ.J.G.H.M. Bergman
Academic Medical Center Bldg. C2-210, Meibergdreef
Outcome results
None listed