Narrow Band Imaging Project on Barrett's Esophagus

March 15, 2023 updated by: PRATEEK SHARMA, Midwest Biomedical Research Foundation

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

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.

Study Overview

Status

Suspended

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Augsburg, Germany
        • University of Regensburg
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam Medical Center
  • United States
    • Illinois
      • Chicago, Illinois, United States
        • The University of Chicago Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
BE with dysplasia.
Patients having Barrett's esophagus with dysplasia.
BE without dysplasia.
Patients having Barrett's esophagus without dysplasia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the inter-observer agreement of a consensus driven NBI classification system in Barrett's esophagus.
Time Frame: 12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the NBI patterns in predicting dysplasia in Barrett's esophagus based on confidence and image quality.
Time Frame: 12 months
Accuracy of the newer patterns for diagnosing dysplasia in Barrett's esophagus based on confidence and image quality perceived by the reviewer.
12 months
Sensitivity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Time Frame: 12 months
Sensitivity of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
12 months
Specificity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Time Frame: 12 months
Specificity of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
12 months
Positive predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Time Frame: 12 months
Positive predictive value of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
12 months
Negative predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Time Frame: 12 months
Negative predictive value of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midwest Biomedical Research Foundation

Collaborators

Kansas City Veteran Affairs Medical Center

Investigators

  • Principal Investigator: Irving Waxman, MD, University of Chicago
  • Principal Investigator: Jacques Bergman, MD, PhD, Amsterdam Umc, Location Vumc
  • Principal Investigator: Helmut Messman, MD, University of Regensburg
  • Principal Investigator: Kenichi Goda, MD, Jikei University
  • Principal Investigator: Motosugu Kato, MD, Hokkaido University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 19, 2012

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS0059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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