Narrow Band Imaging Project on Barrett's Esophagus

NCT01580631 | Suspended

• 1 other identifier: PS0059
• Study Type: observational
• Target: 50
• Locations: 3 countries
• Sites: 4

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.

Conditions

Barrett's Esophagus; Gastroesophageal Reflux Disease

Keywords

Narrow band imaging; Barrett's esophagus; Gastroesophageal reflux disease

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (5)

• Accuracy of the NBI patterns in predicting dysplasia in Barrett's esophagus based on confidence and image quality.

  12 months

• Sensitivity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.

  12 months

• Specificity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.

  12 months

• Positive predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.

  12 months

• Negative predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.

  12 months

Study Arms (2)

BE with dysplasia.

Patients having Barrett's esophagus with dysplasia.

BE without dysplasia.

Patients having Barrett's esophagus without dysplasia.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Midwest Biomedical Research Foundation: lead
• Kansas City Veteran Affairs Medical Center: collaborator

Study Sites (4)

The University of Chicago Medical Center

Chicago, Illinois, United States

Location

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

University of Regensburg

Augsburg, Germany

Location

Amsterdam Medical Center

Amsterdam, Netherlands

Location

Related Publications (11)

• 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. doi: 10.1016/0016-5085(93)90017-7.

  PMID: 8514029 BACKGROUND

• 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. doi: 10.1111/j.1572-0241.2008.01835.x. No abstract available.

  PMID: 18341497 BACKGROUND

• 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. doi: 10.1053/j.gastro.2004.04.010.

  PMID: 15236196 BACKGROUND

• 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. doi: 10.1038/ajg.2009.159. Epub 2009 May 12.

  PMID: 19491849 BACKGROUND

• 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. doi: 10.1053/gast.2002.31879.

  PMID: 11874995 BACKGROUND

• 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. doi: 10.1016/j.cgh.2006.03.001. Epub 2006 Apr 17.

  PMID: 16630761 BACKGROUND

• 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. doi: 10.7326/0003-4819-138-3-200302040-00009.

  PMID: 12558356 BACKGROUND

• Inadomi JM. Surveillance in Barrett's esophagus: a failed premise. Keio J Med. 2009 Mar;58(1):12-8. doi: 10.2302/kjm.58.12.

  PMID: 19398879 BACKGROUND

• 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. doi: 10.1016/s0016-5107(99)70482-7.

  PMID: 9925694 BACKGROUND

• 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. doi: 10.1111/j.1572-0241.2000.03182.x.

  PMID: 11095322 BACKGROUND

• Egger K, Werner M, Meining A, Ott R, Allescher HD, Hofler H, Classen M, Rosch T. Biopsy surveillance is still necessary in patients with Barrett's oesophagus despite new endoscopic imaging techniques. Gut. 2003 Jan;52(1):18-23. doi: 10.1136/gut.52.1.18.

  PMID: 12477753 BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Study Officials

• Prateek Sharma, MD

  Kansas City VA Medical Center

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 19, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

US (2); NL (1); DE (1)