Confocal Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Early Esophageal Cancer(CEBE Study)
Condition: Barrett's Esophagus, Esophageal Intraepithelial Neoplasia
MeSH terms: Neoplasms; Barrett Esophagus
Study type: Interventional

Summary: 
      Endomicroscopy (EM) can improve the diagnosis Barrett's esophagus (BE) and some early
      esophageal cancers (Intra Epithelial Neoplasia (IEN)). EM provides optical biopsies
      comparable to standard histology. Specifically, EM allows targeted biopsy rather than random
      mucosal biopsy during routine endoscopic surveillance of BE or evaluation EIN, 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.

      EM will provide accurate place and size of IEN which will impact the physician's decision to
      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 after the pathology is
      available. This study is important because it will validate single center studies supporting
      the routine use of EM for screening and surveillance of BE.
    

Detailed description: 
      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.
    

Intervention name(s): endomicroscopy
Intervention type(s): Procedure
Intervention description(s): endomicroscopy scope lens has capability to optically evaluate mucosa/submucosa as a microscope
Other intervention name(s): Confocal Laser Microscopy (CLE), EM, confocal microscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Barrett's; BE; esophageal cancer; esophageal dysplasia