An observational study in Barrett's Esophagus and Gastroesophageal Reflux Disease, sponsored by Midwest Biomedical Research Foundation. Suspended at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-16.
Sponsored by Midwest Biomedical Research Foundation · Observational
Narrow Band Imaging(NBI) improves image contrast by allowing the blue light centered at 415 nanometers which is heavily absorbed by oxyhemoglobin to highlight the tissue's microvasculature and enhances detail on the surface of the mucosa revealing subtle changes. Barrett's esophagus(BE) has the mucosal and vessel changes during cancer transformation by angiogenesis. The ability of the NBI scope to visualize submucosal vessels forms the premise for the prediction of dysplasia in BE mucosa.
NBI images of the BE mucosa obtained during endoscopy will be classified by academic endoscopists and community endoscopists initially. The endoscopists will then be asked to predict histopathology based on the NBI surface patterns. This clinical trial will evaluate the inter-observer agreement of a simple, consensus driven narrow band imaging (NBI) classification system of surface patterns and its ability to differentiate dysplastic versus non-dysplastic Barrett's esophagus(BE) in patients undergoing BE screening or surveillance in expert academic centers and in community GI practice as well. Their performance will be evaluated for accuracy, sensitivity, specificity, positive predictive value and negative predictive value of each pattern that is visualized on NBI.
This is a multicenter, prospective, double-blinded study of NBI images from 50 patients enrolled in the study. Patients undergoing BE screening and BE surveillance will be enrolled into the study. After meeting eligibility criteria, and obtaining an informed consent, patients will undergo their routine upper endoscopic examination using white light endoscopy. During the course of the upper endoscopy, the BE surface patterns will be carefully examined with the endoscope in overview mode (with the endoscope in the center of the esophageal lumen) and then in close proximity to the BE surface (approximately 3-5 mm away from the mucosa). In each of these positions, a maximum of 4 high quality images will be obtained from different surface patterns initially with WLE and then using NBI. Image capture will be standardized. All the images will be classified based upon a simplified NBI classification system using two main criteria:(1)mucosal pattern(regular/irregular/uncertain) and (2)vascular pattern (regular/irregular/uncertain). All images will be captured using a high-definition, NBI endoscope (190 endoscopes-GIF-HQ 190 [dual focus],Olympus Inc) and stored in the high quality TIFF format. After images have been obtained, target biopsies will be obtained from each area and submitted for histopathological evaluation in separate jars. From the reports on NBI patterns from the images by Gastroenterologist and corresponding histopathological details, the accuracy and interobserver agreement of this NBI classification system will be determined.
310 studies on the registry are indexed under Barrett Esophagus; 64 are open to participants now.
This study's planned enrollment of 50 is below the median of 127 across 115 observational studies indexed under Barrett Esophagus.
Browse Barrett Esophagus studies →Midwest Biomedical Research Foundation is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligible subjects at the participating institution who meet the inclusion criteria for this study will be offered the opportunity to participate in this clinical trial.
Exclusion Criteria:
Patients having Barrett's esophagus with dysplasia.
Patients having Barrett's esophagus without dysplasia.
Determine the inter-observer agreement of a consensus driven NBI classification system in Barrett's esophagus.
Identifying newer consensus driven NBI classification system in Barrett's esophagus for better inter observer agreement among experts and community/general gastroenterologists. Higher interobserver agreement (measured by Landis and Koch method) on these NBI patterns in Barrett's esophagus will help in diagnosing dysplasia in an uniform way among the gastroenterologists.
Time frame: 12 months
Accuracy of the NBI patterns in predicting dysplasia in Barrett's esophagus based on confidence and image quality.
Accuracy of the newer patterns for diagnosing dysplasia in Barrett's esophagus based on confidence and image quality perceived by the reviewer.
Time frame: 12 months
Sensitivity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Sensitivity of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
Time frame: 12 months
Specificity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Specificity of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
Time frame: 12 months
Positive predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Positive predictive value of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
Time frame: 12 months
Negative predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Negative predictive value of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
Time frame: 12 months
This study is suspended, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Midwest Biomedical Research Foundation