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Barrett's Esophagus Related Neoplasia (BERN) Project

RECRUITINGSponsored by Midwest Biomedical Research Foundation
Actively Recruiting
SponsorMidwest Biomedical Research Foundation
Started2007-05-15
Est. completion2026-11-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT00590239

Summary

* The use of high resolution endoscopy (HRE), narrow band imaging (NBI) and chromoendoscopy increases the detection rates of Barrett's esophagus (BE) and early neoplasia. * Endoscopic mucosal resection (EMR) will improve the accuracy for detection of dysplasia/early neoplasia. Specific Aim 1 - To create a video-atlas of non-dysplastic and dysplastic/early neoplastic lesions in patients with BE. This will be used for training purposes and to assess learning curve associated with these new technologies. Specific Aim 2 - To create a standardized classification system for the mucosal and vascular patterns observed in patients with BE. Specific Aim 3 - To determine the interobserver agreement using the video-atlas for the mucosal and vascular patterns classification agreed upon. Specific Aim 4 - To determine the endoscopic detection rate of esophageal cancer or precancerous lesions removed during endoscopy. Specific Aim 5 - To determine the pathologic and clinical outcomes of patients undergoing EMR/ablation; including morbidity, mortality and complications of the procedure. Results to date (June 2008) : this study is active and open to enrollment. Currently 26 patients have enrolled in this study at the Kansas City VA medical center. In order to participate, patients must be eligible for care at the KCVA hospital.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* 18-80 years
* Patients must be able to provide written informed consent
* Patients referred for endoscopy for screening/surveillance of BE or for endoscopic treatment of BE with early mucosal neoplasia

Exclusion Criteria:

* Current use of aspirin, non-steroidal anti-inflammatory agents(NSAIDs),or chronic anticoagulants that cannot be discontinued prior to the procedure.
* Inability to provide written informed consent
* Significant thrombocytopenia or coagulopathy
* Any significant co-morbid condition that would prevent the safe administration of conscious sedation

Conditions4

Barrett's EsophagusCancerGastroesophageal RefluxNeoplasms

Locations1 site

Kansas city VA Medical center
Kansas City, Missouri, 64128
April Higbee, RN816-861-4700april.higbee@va.gov

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