Barrett's Esophagus Related Neoplasia (BERN) Project
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMidwest Biomedical Research Foundation
About this trial
* 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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population is a Veteran population presenting to a VA Hospital upper endoscopy unit
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Video-atlas creation
To create a video-atlas of early neoplastic lesions in patients with BE. This will be used for training purposes and to assess learning curve associated with these new technologies.
Time frame
March 2007 - June 20162
Pathologic and Clinical Outcomes
To determine the pathologic and clinical outcomes of patients undergoing EMR / ablation; including morbidity, mortality and complications of the procedure.
Time frame
2007 - 2016Secondary outcomes
1
Interobserver agreement for the detection of early neoplasia
To determine the interobserver agreement using the video-atlas for the detection of early neoplasia.
Time frame
2015 - 20162
Efficacy of endoscopic detection of early esophageal lesions
To determine the endoscopic detection rate of early neoplastic lesions by expert endoscopists, experienced endoscopists, and trainees. The endoscopist will be graded as 1.) Trainees (in fellowship training); 2.) Experienced endoscopist (\<5 yrs of experience in esophageal diseases); 3.) Expert endoscopist (\>5 yrs of experience in esophageal diseases).
Time frame
2007-2016Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Midwest Biomedical Research Foundation
Lead sponsor
Kansas City Veteran Affairs Medical Center
Collaborator
Source ClinicalTrials.gov