Trial Information

In Vivo Endomicroscopy (EM) for Improved Diagnosis of Barrett's Esophagus (BE) and Associated Neoplasia: A Multicenter Randomized Controlled Trial of Diagnostic Yield and Clinical Impact

The central hypothesis is that endomicroscopy (EM) can improve the efficiency of the
endoscopic diagnosis of Barrett's esophagus (BE) and associated Intraepithelial
neoplasia(IEN), providing in-vivo optical biopsies comparable to standard histology.
Specifically, EM will enable targeted biopsy rather than random mucosal biopsy during
routine endoscopic surveillance of BE or endoscopic evaluation of patients with suspected or
proven unlocalized IEN, which will improve the diagnostic yield of mucosal samples for BE
IEN. Furthermore, when combined with high resolution endoscopy, EM may improve the overall
in vivo detection of IEN in lesions as well as flat mucosa.

The investigators also hypothesize that EM will provide additional accurate information
regarding the presence of IEN that will impact upon the physician's decision to obtain a
mucosal biopsy or perform endoscopic mucosal resection (EMR). This could potentially
minimize the number of unnecessary biopsies and as well as enable the physician to perform
EMR at the time of the initial examination, rather than delaying endoscopic treatment to
another procedure after the pathology from the mucosal biopsies are available. This study is
important because it will validate single center studies supporting the routine use of EM
for screening and surveillance of BE.