The diagnosis of dysplasia and early adenocarcinoma in BE remains challenging. At present,
endoscopy with biopsy of suspected BE lesions is the only available method. However, the
endoscopic recognition of early dysplasia in BE relies on the subjective visual recognition
by an endoscopist. The subtle mucosal variations and early dysplastic changes in the
esophagus may easily be missed. The development of a wide-field, high resolution endoscopic
microscopy could enhance the early detection and treatment of dysplasia in BE.
Observational
Observational Model: Cohort, Time Perspective: Prospective
The correlation of features seen on VLE images to those seen on histopathology from mucosal resection specimens.
All VLE images will be evaluated by two independent reviewers (not the trial endoscopist performing the scan), who are blinded to the histological finding of the corresponding EMR specimen. A predefined classification scheme will be used for VLE assessment.
VLE images will be obtained during the day of the EGD (baseline). There is no follow-up period for this protocol. Correlation of features from VLE to histo will occur at the completion of enrollment.
No
Jacques Bergman, MD
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Netherlands: Dutch Health Care Inspectorate
12_01
NCT01862666
May 2013
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