Barrett's Esophagus Related Neoplasia (BERN) Project

Recruiting now

Conditions studied: Barrett's Esophagus, Neoplasms, Gastroesophageal Reflux

In brief

* 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.

Key facts

Study ID

NCT00590239

Run by

Midwest Biomedical Research

People needed

150

Starts

2007-05-15

Expected to finish

2026-12-30

Last updated by the study team

2024-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kansas city VA Medical center — Kansas City, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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