Narrow Band Imaging Project on Barrett's Esophagus

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Conditions studied: Barrett's Esophagus, Gastroesophageal Reflux Disease

In brief

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.

Key facts

Study ID

NCT01580631

Run by

Midwest Biomedical Research

People needed

50

Starts

2012-10-01

Expected to finish

2025-12-01

Last updated by the study team

2023-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• The subject is pregnant or planning a pregnancy during the study period (12 months after treatment)
• Esophageal stricture preventing passage of endoscope or catheter
• Active erosive esophagitis
• Prior endoscopic therapy with endoscopic mucosal resection, radiofrequency ablation, etc.
• History of esophageal varices or coagulopathy
• Prior radiation therapy to the esophagus, except head and neck region radiation therapy.
• Evidence of esophageal varices during treatment endoscopy
• Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
• The subject is currently enrolled in an investigational drug or device trial that clinically interferes with the current study.
• Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol

Where it is running

• The University of Chicago Medical Center — Chicago, Illinois, United States
• Kansas City VA Medical Center — Kansas City, Missouri, United States
• University of Regensburg — Augsburg, Germany
• Amsterdam Medical Center — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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