Barrett's Esophagus Related Neoplasia (BERN) Project
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Purpose
- 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.
| Condition |
|---|
|
Barrett's Esophagus Neoplasms Gastroesophageal Reflux |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Endoscopic Detection of Early Neoplasia in Patients With Barrett's Esophagus |
| Estimated Enrollment: | 150 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The study population is a Veteran population presenting to a VA Hospital upper endoscopy unit
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
Contacts and Locations| Contact: April Higbee, BN | 8168614700 ext 57456 | April.Higbee@va.gov |
| United States, Missouri | |
| Kansas city VA Medical center | Recruiting |
| Kansas city, Missouri, United States, 64128 | |
| Contact: April Higbee, RN 816-861-4700 ext 57456 april.higbee@va.gov | |
| Sub-Investigator: Amit Rastogi, MD | |
| Sub-Investigator: Ajay Bansal, MD | |
| Principal Investigator: Prateek Sharma, MD | |
| Principal Investigator: | Prateek Sharma, MD | Kansas city VA Medical Center |
More Information
No publications provided
| Responsible Party: | PRATEEK SHARMA, Principal Investigator, Midwest Biomedical Research Foundation |
| ClinicalTrials.gov Identifier: | NCT00590239 History of Changes |
| Other Study ID Numbers: | PS0044 |
| Study First Received: | December 26, 2007 |
| Last Updated: | October 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Midwest Biomedical Research Foundation:
|
Barrett's Esophagus Neoplasia Endoscopic mucosal resection High resolution endoscopy Chromoendoscopy |
Additional relevant MeSH terms:
|
Barrett Esophagus Neoplasms Gastroesophageal Reflux Digestive System Abnormalities Digestive System Diseases |
Esophageal Diseases Gastrointestinal Diseases Esophageal Motility Disorders Deglutition Disorders |
ClinicalTrials.gov processed this record on June 17, 2013