In Vivo Confocal Endomicroscopy for Improved Diagnosis of Barrett’s Esophagus and Associated Neoplasia: A Multicenter Randomized Controlled Trial of Diagnostic Yield and Clinical Impact
The Johns Hopkins Hospital is leading a multicenter research study to determine the best way to identify cancer in people with Barrett’s esophagus. Gastroenterologists will compare 2 different techniques (high resolution endoscopy (HRE) and confocal laser endomicroscopy (EM) to examine the esophagus. Endomicroscopy is a relatively new advance in endoscopic imaging, to see highly magnified pictures of the esophageal lining and better guide the places to take biopsies. . The research study will evaluate what EM adds to high definition video endoscopy in patients undergoing routine evaluation or those with suspected pre-cancer (dysplasia) or early cancers.
Adult patients aged 18- 80 years with known Barrett’s esophagus may be eligible for this research study. Eligible patients will be studied with HRE or HRE plus EM. A standard of care systematic biopsy protocol will be performed in all patients, in addition to targeted sampling of suspicious areas after careful endoscopic evaluation.
This international, multicenter, double-blind randomized controlled trial will recruit a total of 200 patients over 1 year at 5 sites (Johns Hopkins in Baltimore, The Cleveland Clinic Foundation in Cleveland, Mt. Sinai Hospital in New York, Massachusetts General Hospital in Boston, and University of Mainz Germany).
Interested individuals can contact the study team at Johns Hopkins (call 410-502-9795 or 410-502-2893, or email firstname.lastname@example.org).
JHM IRB study number NA_00025471
Principal investigator: Marcia Irene Canto, MD., MHS