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Barrett's Esophagus Related Neoplasia (BERN) Project

NCT00590239 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-11-22

No results posted yet for this study

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.

Conditions

  • Barrett's Esophagus
  • Neoplasms
  • Gastroesophageal Reflux

Sponsors & Collaborators

  • Kansas City Veteran Affairs Medical Center

    collaborator FED

  • Midwest Biomedical Research Foundation

    lead OTHER

Principal Investigators

  • Prateek Sharma, MD · Kansas City VA Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-15
Primary Completion
2026-11-01
Completion
2026-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00590239 on ClinicalTrials.gov