Kurzfassung

BACKGROUND: Confocal laser endomicroscopy (EM) is a relatively new advance in endoscopic imaging, which allows in vivo microscopic imaging of gastrointestinal mucosa. Data from a single center randomized controlled trial at Johns Hopkins Hospital suggest that in vivo imaging doubles the diagnostic yield for high grade dysplasia and cancer in EM-guided mucosal biopsies in BE patients with suspected early intraepithelial neoplasia (IEN, i.e. high grade dysplasia or early adenocarcinoma),...BACKGROUND: Confocal laser endomicroscopy (EM) is a relatively new advance in endoscopic imaging, which allows in vivo microscopic imaging of gastrointestinal mucosa. Data from a single center randomized controlled trial at Johns Hopkins Hospital suggest that in vivo imaging doubles the diagnostic yield for high grade dysplasia and cancer in EM-guided mucosal biopsies in BE patients with suspected early intraepithelial neoplasia (IEN, i.e. high grade dysplasia or early adenocarcinoma), compared to a standard random biopsy protocol. Accurate in vivo diagnosis also allows up to two thirds of BE patients undergoing routine surveillance to avoid mucosal biopsy by obtaining accurate optical biopsies HYPOTHESES: We hypothesize that EM is an accurate endoscopic technology that will increase the diagnostic yield of mucosal biopsy for diagnosis of IEN in BE patients evaluated with high resolution white light endoscopy (HRE) due to more selective tissue acquisition. We also hypothesize that it will allow real time decision-making regarding the need to obtain a mucosal biopsy or perform endoscopic mucosal resection. AIMS: The specific aims of this project are:1) to compare the diagnostic yield of a standard protocol of HRE with 4-quadrant random biopsy along with direct biopsy of mucosal lesions (HRE alone, Group A) to that of HRE followed by EM and directed biopsy (HRE-EM, Group B) for the diagnosis of BE-associated IEN in flat mucosa as well as mucosal lesions; 2) to assess the potential clinical impact of HRE-EM on the diagnosis and surveillance of BE associated IEN by determining if EM alters the decision to obtain mucosal biopsies or perform endoscopic mucosal resection (EMR); 3) to determine the performance characteristics of HREEM (Group B) for the prediction of BE-associated IEN in mucosal lesions and flat mucosa, using the pathologic diagnosis of mucosal biopsies as the reference standard. METHODS: This investigator-initiated international, multicenter, double-blind randomized controlled trial. A total of 200 patients will be enrolled over 1 year. Biopsy-proven BE patients undergoing routine surveillance or referred for suspected IEN will be randomized to either HRE alone (Group A) or HRE + EM (Group B) using a 1:1 ratio. In Group A patients, HRE with 4 quadrant mucosal biopsies every 1-2 cm will be performed. In Group B patients, HRE will be performed followed by fluorescein-aided EM in a 4-quadrant fashion every 1-2 cm from the GE junction to Z line. CLINICAL SIGNIFICANCE: This will be the first large prospective trial that hopes to demonstrate the role of HRE and EM in the in vivo endoscopic evaluation and treatment of BE patients with and without suspected neoplasia. . If successful, this study’s results may change the current paradigm of surveillance endoscopy with 4-quadrant biopsies of BE to EM directed biopsies of suspicious lesions only. This has the potential to increase the diagnostic yield and decrease the number of biopsies in Barrett’s esophagus patients, as well as influence in vivo decision-making regarding the need for biopsy or EMR.» weiterlesen» einklappen