Confocal Laser Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Associated Neoplasia
Barrett's esophagus is a leading cause of esophageal adenocarcinoma. Detection of dysplasia
and early cancers in Barrett's esophagus can be challenging, time-consuming and expensive.
Small lesions may be difficult to detect with standard endoscopy protocols. Confocal laser
endomicroscopy (CLE) is a new type of endoscopy where a small confocal microscope is built
into the tip of a standard endoscope. For this study, we are comparing confocal laser
endomicroscopy (CLE) with targeted biopsies with standard endoscopy (EGD)and biopsy for
Barrett's esophagus to determine if CLE is more effective for detecting dysplasia and
Participants with Barrett's esophagus in this study undergo 1) CLE with targeted mucosal
biopsies (biopsy only taken if CLE shows abnormal tissue) and 2) standard EGD with biopsies.
The order of procedures is randomized (some patients have CLE first while others have
standard EGD first).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)
The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)
Marcia I Canto, MD, MHS
Division of Gastroenterology, Johns Hopkins University School of Medicine
United States: Institutional Review Board
|Johns Hopkins Hospital||Baltimore, Maryland 21287|