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

18 Years
Not Enrolling
Barrett's Esophagus, Gastroesophageal Reflux Disease

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Trial Information

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

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.

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,

- History of esophageal varices or coagulopathy

- Prior radiation therapy to the esophagus, except head and neck region radiation

- 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

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Determine the inter-observer agreement of a consensus driven NBI classification system in Barrett's esophagus.

Outcome Description:

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.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Prateek Sharma, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kansas City VA Medical Center


United States: Federal Government

Study ID:




Start Date:

October 2012

Completion Date:

December 2013

Related Keywords:

  • Barrett's Esophagus
  • Gastroesophageal Reflux Disease
  • Narrow band imaging
  • Barrett's esophagus
  • Gastroesophageal reflux disease
  • Barrett Esophagus
  • Gastroesophageal Reflux



The University of Chicago Medical Center Chicago, Illinois  60637-1470
Kansas City VA Medical Center Kansas City, Missouri  64128