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Narrow Band Imaging Project on Barrett's Esophagus

NCT01580631 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-03-16

No results posted yet for this study

Summary

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.

Conditions

  • Barrett's Esophagus
  • Gastroesophageal Reflux Disease

Sponsors & Collaborators

  • Kansas City Veteran Affairs Medical Center

    collaborator FED

  • Midwest Biomedical Research Foundation

    lead OTHER

Principal Investigators

  • Prateek Sharma, MD · Kansas City VA Medical Center

  • Irving Waxman, MD · University of Chicago

  • Jacques Bergman, MD, PhD · Amsterdam UMC, location VUmc

  • Helmut Messman, MD · University of Regensburg

  • Kenichi Goda, MD · Jikei University

  • Motosugu Kato, MD · Hokkaido University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • United States
  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01580631 on ClinicalTrials.gov