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Treatment for Acid Reflux (BERN Trial)

N/A
Recruiting
Led By Prateek Sharma, MD
Research Sponsored by Midwest Biomedical Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2015 - 2016
Awards & highlights

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.

Eligible Conditions
  • Acid Reflux
  • Tumors
  • Barrett's Esophagus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2015 - 2016
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2015 - 2016 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathologic and Clinical Outcomes
Video-atlas creation
Secondary outcome measures
Efficacy of endoscopic detection of early esophageal lesions
Interobserver agreement for the detection of early neoplasia

Find a Location

Who is running the clinical trial?

Kansas City Veteran Affairs Medical CenterFED
23 Previous Clinical Trials
8,418 Total Patients Enrolled
Midwest Biomedical Research FoundationLead Sponsor
25 Previous Clinical Trials
9,168 Total Patients Enrolled
Prateek Sharma, MDPrincipal InvestigatorKansas City VA Medical Center
18 Previous Clinical Trials
8,651 Total Patients Enrolled
~16 spots leftby Nov 2026