Barrett's Esophagus Related Neoplasia (BERN) Project
Part of paid clinical trials in Kansas City, Missouri.
- Sponsor
- Midwest Biomedical Research Foundation
- Study ID
- NCT00590239
- Status
- Recruiting
Conditions
- Barrett's Esophagus
- Gastroesophageal Reflux
- Neoplasms
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
* 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 Dates
- Start date
- May 15, 2007
- Status verified
- Nov 2024
- Primary completion
- Nov 1, 2026
- Completion
- Dec 30, 2026
Study Design
- Enrollment
- 150 participants (estimated)
Primary Outcome Measure
Video-atlas creation [ Time Frame: March 2007 - June 2016 ]
Central Contacts
- April Higbee, BN8168614700
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Kansas city VA Medical center | Kansas City | Missouri | 64128 | Amit Rastogi, MD (SUB_INVESTIGATOR) Ajay Bansal, MD (SUB_INVESTIGATOR) Prateek Sharma, MD (PRINCIPAL_INVESTIGATOR) |
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