Assessment of a Consensus Driven Narrow Band Imaging (NBI) Pattern Classification System in Barrett's Esophagus (BE)

Status: Suspended
Location: See all (4) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patients age: ≥ 18 years

• Undergoing endoscopy for surveillance or endoscopic treatment of Barrett's esophagus

• Ability to take oral proton pump inhibitor

• For female subjects of childbearing potential, a negative urine pregnancy test within 2 weeks of enrollment and any subsequent endoscopy encounter

• Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the investigational plan

• Ability to discontinue Aspirin/NSAIDs/Clopidogrel 7 days before and after all ablation procedures

• Ability to provide written, informed consent and understands the responsibilities of trial participation

Locations
United States
Illinois
The University of Chicago Medical Center
Chicago
Missouri
Kansas City VA Medical Center
Kansas City
Other Locations
Germany
University of Regensburg
Augsburg
Netherlands
Amsterdam Medical Center
Amsterdam
Time Frame
Start Date: October 2012
Completion Date: December 2019
Participants
Target number of participants: 50
Treatments
BE with dysplasia.
Patients having Barrett's esophagus with dysplasia.
BE without dysplasia.
Patients having Barrett's esophagus without dysplasia.
Authors
Prateek Sharma, Irving Waxman, Helmut Messman, Kenichi Goda, Jacques Bergman, Motosugu Kato
Sponsors
Leads: Midwest Biomedical Research Foundation
Collaborators: Kansas City Veteran Affairs Medical Center

This content was sourced from clinicaltrials.gov

Similar Clinical Trials