At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Detection Of Intestinal Metaplasia And High Grade Dysplasia In Barrett's Esophagus Using Novel Imaging Techniques - A Randomized Controlled Trial.
In Brief
A clinical study evaluating NBI-AFI imaging and Standard Endoscopy for Barrett Esophagus and Gastroesophageal Reflux. Completed, enrolled 130 participants across 3 sites in 2 countries.
Detailed Summary
Primary Aim: In patients with endoscopically suspected BE, compared to standard endoscopy, novel techniques (NBI and AFI) with target biopsies will * Detect more patients with intestinal metaplasia * Detect more areas of high grade dysplasia * Require fewer biopsies and a shorter time for procedure completion Secondary Aim: * Compare the yield of high-grade dysplasia(HGD)using NBI/AFI versus standard endoscopy with biopsy. * Compare the number of biopsies and procedure times for NBI/AFI versus standard endoscopy with biopsy. * Compare the inter-observer variability in classifying different mucosal and vascular patterns observed by NBI/AFI using kappa statistics.
Study Details
Timeline
Interventions
Narrow Band Imaging- Patients will be evaluated with a standard magnification endoscope (Olympus GIF Q240Z, 115x or GIF-H180 or equivalent) using a NBI light source.Target biopsies with standard biopsy forceps will be obtained from the different visualized patterns in separate jars. Autofluorescence Imaging- Patients will be evaluated using a prototype autofluorescence endoscope (Olympus, Tokyo, Japan; excitation 395-475 nm, fluorescence detection 490-625 nm, red reflectance 600-620 nm and green reflectance 540-560 nm).In this system, normal squamous and non-dysplastic BE appears green while the dysplastic areas appear magenta/purplish. Targeted biopsies will be obtained from the areas with abnormal fluorescence.
Standard Endoscopy- Patients will undergo EGD with biopsies using a standard diagnostic video endoscope (Olympus, GIF 140 or 160) using the Seattle protocol - 4 quadrant biopsies using standard biopsy forceps every 2 cms; stored in separate jars.