Clinical trial NCT01580631: Narrow Band Imaging Project on Barrett's Esophagus
Official title: Assessment of a Consensus Driven Narrow Band Imaging (NBI) Pattern Classification System in Barrett's Esophagus (BE)
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Barrett's Esophagus
Gastroesophageal Reflux Disease
Keywords: Narrow band imaging
Barrett's esophagus
Gastroesophageal reflux disease
Lead sponsor: Midwest Veterans' Biomedical Research Foundation
Sponsor class: OTHER
Collaborators: name: Kansas City Veteran Affairs Medical Center
First posted: 2012-04-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Determine the inter-observer agreement of a consensus driven NBI classification system in Barrett's esophagus.
timeFrame: 12 months
Secondary outcomes:
measure: Accuracy of the NBI patterns in predicting dysplasia in Barrett's esophagus based on confidence and image quality.
timeFrame: 12 months
measure: Sensitivity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
timeFrame: 12 months
measure: Specificity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
timeFrame: 12 months
measure: Positive predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
timeFrame: 12 months
measure: Negative predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Augsburg
country: Germany
facility: University of Regensburg
city: Amsterdam
country: Netherlands
facility: Amsterdam Medical Center
Study officials:
affiliation: Kansas City VA Medical Center
name: Prateek Sharma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Irving Waxman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, location VUmc
name: Jacques Bergman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Regensburg
name: Helmut Messman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jikei University
name: Kenichi Goda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hokkaido University
name: Motosugu Kato, MD
role: PRINCIPAL_INVESTIGATOR
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