Narrow Band Imaging Project on Barrett's Esophagus

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.

Sex

All

Minimum age

18 Years

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

• BACKGROUNDReid 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
• BACKGROUNDWang 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
• BACKGROUNDSharma 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
• BACKGROUNDCooper 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
• BACKGROUNDCorley 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
• BACKGROUNDSharma 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
• BACKGROUNDInadomi 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.