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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
compare diagnostic yield
Compare the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRE plus EM with directed biopsy (HRE-EM-DB) over HRE with directed biopsy of all mucosal lesions followed by random biopsy (HRE-DB-RB) to diagnose BE in flat mucosa and mucosal lesions The mean diagnostic yield for IEN will be calculated (number of mucosal biopsies and EMR specimens with HGD or CA divided by total number of mucosal biopsies obtained) by group and compared, using a chi square or Fisher's exact test for independent groups, depending on the distribution of the data.
Marcia I Canto, MD
Johns Hopkins Medicine
United States: Institutional Review Board
|Mount Sinai School of Medicine||New York, New York 10029|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|University of Pennsylvania Medical Institution||Philadelphia, Pennsylvania 19104|