Narrow Band Imaging Project on Barrett's Esophagus

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Midwest Biomedical Research Foundation
Sponsor:
Collaborator:
Kansas City Veteran Affairs Medical Center
Information provided by (Responsible Party):
PRATEEK SHARMA, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier:
NCT01580631
First received: April 4, 2012
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition
Barrett's Esophagus
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of a Consensus Driven Narrow Band Imaging (NBI) Pattern Classification System in Barrett's Esophagus (BE)

Resource links provided by NLM:


Further study details as provided by Midwest Biomedical Research Foundation:

Primary Outcome Measures:
  • Determine the inter-observer agreement of a consensus driven NBI classification system in Barrett's esophagus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Accuracy of the NBI patterns in predicting dysplasia in Barrett's esophagus based on confidence and image quality. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Accuracy of the newer patterns for diagnosing dysplasia in Barrett's esophagus based on confidence and image quality perceived by the reviewer.

  • Sensitivity of the newer NBI classification in identifying dysplasia in Barrett's esophagus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Sensitivity of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.

  • Specificity of the newer NBI classification in identifying dysplasia in Barrett's esophagus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Specificity of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.

  • Positive predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Positive predictive value of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.

  • Negative predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Negative predictive value of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.


Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
BE with dysplasia.
Patients having Barrett's esophagus with dysplasia.
BE without dysplasia.
Patients having Barrett's esophagus without dysplasia.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580631

Contacts
Contact: April Higbee, RN,BSN 816-861-4700 ext 57456 april.higbee@va.gov

Locations
United States, Illinois
The University of Chicago Medical Center Not yet recruiting
Chicago, Illinois, United States
Contact: Irving Waxman, MD         
Principal Investigator: Irving Waxman, MD         
United States, Missouri
Kansas City VA Medical Center Recruiting
Kansas City, Missouri, United States, 64128
Contact: April Higbee, RN,BSN    816-861-4700 ext 57456    april.higbee@va.gov   
Principal Investigator: Prateek Sharma, MD         
Germany
University of Regensburg Recruiting
Augsburg, Germany
Contact: Helmut Messman, MD         
Principal Investigator: Helmut Messman, MD         
Netherlands
Amsterdam Medical Center Recruiting
Amsterdam, Netherlands
Contact: Jacques Bergman         
Principal Investigator: Jacques Bergman, MD         
Sponsors and Collaborators
Midwest Biomedical Research Foundation
Kansas City Veteran Affairs Medical Center
Investigators
Principal Investigator: Prateek Sharma, MD Kansas City VA Medical Center
Principal Investigator: Irving Waxman, MD University of Chicago
Principal Investigator: Jacques Bergman, MD, PhD Amsterdam Medical Center
Principal Investigator: Helmut Messman, MD University of Regensburg
Principal Investigator: Kenichi Goda, MD Jikei University
Principal Investigator: Motosugu Kato, MD Hokkaido University
  More Information

Publications:

Responsible Party: PRATEEK SHARMA, Principal Investigator, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier: NCT01580631     History of Changes
Other Study ID Numbers: PS0059
Study First Received: April 4, 2012
Last Updated: May 12, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Midwest Biomedical Research Foundation:
Narrow band imaging
Barrett's esophagus
Gastroesophageal reflux disease

Additional relevant MeSH terms:
Barrett Esophagus
Gastroesophageal Reflux
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on July 20, 2014