Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy
This is a cross-over tandem study to directly address the low sensitivity and specificity of
enhanced macroscopic endoscopic imaging devices by determining whether probe-based Confocal
Laser Endomicroscopy (pCLE), as a supplement to Narrow Band Imaging (NBI) can further
improve sensitivity and specificity to a level that would be acceptable to avoid random
biopsy, and better direct biopsy of suspicious areas. The study is also addressing pCLE as a
supplement to standard white light endoscopy and random biopsy alone. In fact, the study is
powered to evaluate per lesion sensitivity and specificity of confocal imaging as applied to
lesions identified by white light endoscopy. Therefore, the study addresses the shortcomings
of standard white light endoscopy (high number of random biopsies, less than ideal directed
biopsy of suspicious areas) and the primary shortcomings of NBI (low specificity with
resultant high false positives, again resulting in many unnecessary biopsies).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Comparative histopathology-confirmed measures of per lesion sensitivity and per lesion specificity of pCLE for the detection of high grade dysplasia and early carcinoma in Barrett's esophagus.
Centralized histopathology confirmation within 4-6 weeks
Yes
Prateek Sharma, MD
Principal Investigator
Veterans Affairs Hospital, Kansas City
United States: Institutional Review Board
MKT-2008-BE-01
NCT00795184
November 2008
February 2010
Name | Location |
---|---|
Mayo Clinic | Jacksonville, Florida 32224 |
New York Presbyterian Hospital/Columbia University Medical Center | New York, New York 10032 |
Veterans Affairs Hospital | Kansas City, Missouri 64128 |