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Trial #NCT01580631
Barrett's Esophagus Clinical Trials

Narrow Band Imaging Project on Barrett's Esophagus


Assessment of a Consensus Driven Narrow Band Imaging (NBI) Pattern Classification System in Barrett's Esophagus (BE)
Study ID: PS0059; Source: Midwest Biomedical Research Foundation
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Recruiting
Country Multiple Countries
Study type Observational
Enrollment 50
Start date October 2012
Completion date December 2015
Phase N/A
Sponsor Midwest Biomedical Research Foundation
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.
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:
Gender: Both
Age: 18 Years - N/A
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
Outcome:
Primary outcome
  • Determine the inter-observer agreement of a consensus driven NBI classification system in Barrett's esophagus.
    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.
    Time frame: 12 months
Secondary outcome
  • Accuracy of the NBI patterns in predicting dysplasia in Barrett's esophagus based on confidence and image quality.
    Accuracy of the newer patterns for diagnosing dysplasia in Barrett's esophagus based on confidence and image quality perceived by the reviewer.
    Time frame: 12 months
  • Negative predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
    Negative predictive value of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
    Time frame: 12 months
  • Positive predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
    Positive predictive value of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
    Time frame: 12 months
  • Sensitivity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
    Sensitivity of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
    Time frame: 12 months
  • Specificity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
    Specificity of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
    Time frame: 12 months
Contacts:
  • Helmut Messman, MD; University of Regensburg (Principal Investigator)
  • Irving Waxman, MD; University of Chicago (Principal Investigator)
  • Jacques Bergman, MD, PhD; Amsterdam Medical Center (Principal Investigator)
  • Kenichi Goda, MD; Jikei University (Principal Investigator)
  • Motosugu Kato, MD; Hokkaido University (Principal Investigator)
  • Prateek Sharma, MD; Kansas City VA Medical Center (Principal Investigator)
  • April Higbee, RN,BSN;
    Phone: 816-861-4700
Location Country Status
The University of Chicago Medical Center Chicago, Illinois United States Not yet recruiting
Kansas City VA Medical Center Kansas City, Missouri United States Recruiting
University of Regensburg Augsburg, Germany Recruiting
Amsterdam Medical Center Amsterdam, Netherlands Recruiting
Sponsors:
  • Midwest Biomedical Research Foundation - (Lead Sponsor)
  • Kansas City Veteran Affairs Medical Center - Collaborator

Related trials: References:
  • Cooper GS, Kou TD, Chak A. Receipt of previous diagnoses and endoscopy and outcome from esophageal adenocarcinoma: a population-based study with temporal trends. Am J Gastroenterol. 2009 Jun;104(6):1356-62. Epub 2009 May 12.
  • Corley DA, Levin TR, Habel LA, Weiss NS, Buffler PA. Surveillance and survival in Barrett's adenocarcinomas: a population-based study. Gastroenterology. 2002 Mar;122(3):633-40.
  • Egger K, Werner M, Meining A, Ott R, Allescher HD, Höfler H, Classen M, Rösch T. Biopsy surveillance is still necessary in patients with Barrett's oesophagus despite new endoscopic imaging techniques. Gut. 2003 Jan;52(1):18-23.
  • Falk GW, Rice TW, Goldblum JR, Richter JE. Jumbo biopsy forceps protocol still misses unsuspected cancer in Barrett's esophagus with high-grade dysplasia. Gastrointest Endosc. 1999 Feb;49(2):170-6.
  • Inadomi JM, Sampliner R, Lagergren J, Lieberman D, Fendrick AM, Vakil N. Screening and surveillance for Barrett esophagus in high-risk groups: a cost-utility analysis. Ann Intern Med. 2003 Feb 4;138(3):176-86.
  • Inadomi JM. Surveillance in Barrett's esophagus: a failed premise. Keio J Med. 2009 Mar;58(1):12-8. Review.
  • Reid BJ, Blount PL, Feng Z, Levine DS. Optimizing endoscopic biopsy detection of early cancers in Barrett's high-grade dysplasia. Am J Gastroenterol. 2000 Nov;95(11):3089-96.
  • Reid BJ, Sanchez CA, Blount PL, Levine DS. Barrett's esophagus: cell cycle abnormalities in advancing stages of neoplastic progression. Gastroenterology. 1993 Jul;105(1):119-29.
  • Sharma P, Falk GW, Weston AP, Reker D, Johnston M, Sampliner RE. Dysplasia and cancer in a large multicenter cohort of patients with Barrett's esophagus. Clin Gastroenterol Hepatol. 2006 May;4(5):566-72. Epub 2006 Apr 17.
  • Sharma P, McQuaid K, Dent J, Fennerty MB, Sampliner R, Spechler S, Cameron A, Corley D, Falk G, Goldblum J, Hunter J, Jankowski J, Lundell L, Reid B, Shaheen NJ, Sonnenberg A, Wang K, Weinstein W; AGA Chicago Workshop. A critical review of the diagnosis and management of Barrett's esophagus: the AGA Chicago Workshop. Gastroenterology. 2004 Jul;127(1):310-30. Review.
  • Wang KK, Sampliner RE; Practice Parameters Committee of the American College of Gastroenterology. Updated guidelines 2008 for the diagnosis, surveillance and therapy of Barrett's esophagus. Am J Gastroenterol. 2008 Mar;103(3):788-97.
Terms
  • Barrett's esophagus
  • Narrow band imaging
  • Gastroesophageal reflux disease
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