Study of Endoscopic Barrett's Esophagus Diagnosis

Sponsor
Oregon Health and Science University (Other)
Overall Status
Terminated
CT.gov ID
NCT00591461
Collaborator
(none)
13
2
27
6.5
0.2

Study Details

Study Description

Brief Summary

Barrett's esophagus (BE) is a condition that often occurs in patients who have had GERD for a long time. The researchers are interested in BE because it can sometimes become a cancer in the esophagus. The way that we currently diagnose BE is by performing an upper endoscopy and looking for a change in the color of the esophagus. This color change may represent BE. If the doctor sees this, he/she may take biopsies of this area.

Studies have shown that making the diagnosis of BE can be hard to make. One of the reasons why this may be is because doctors may interpret what they see differently during the procedure. In other words, they may see an esophagus that appears normal in color or abnormal in color.

The purpose of this study is to compare two doctors' impressions of the appearance of the esophagus during a single endoscopy procedure.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    13 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Study on the Interobserver Agreement of Endoscopic Barrett's Esophagus
    Study Start Date :
    Dec 1, 2007
    Actual Primary Completion Date :
    Mar 1, 2010
    Actual Study Completion Date :
    Mar 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Study participants must be older than 18 years of age who are having an endoscopy performed to evaluate symptoms of GERD such as heartburn, acid taste in the mouth, dysphagia, dyspepsia, or those who are having a screening/surveillance exam for BE.

    Outcome Measures

    Primary Outcome Measures

    1. The primary outcome will be the interobserver variability in the presence of columnar epithelium as well as the measured lengths. [one endoscopy visit]

    Secondary Outcome Measures

    1. frequency of pathology-confirmed BE [one endoscopy visit]

    2. variables that predict endoscopic interobserver agreement and path-confirmation [one endoscopy visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • History of (h/o) GERD

    • Upper GI symptoms such as acid taste in mouth, dysphagia, dyspepsia

    • Screening or surveillance exam for BE

    Exclusion Criteria:
    • Unable to consent

    • History of esophageal varices

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 OHSU Portland Oregon United States 97239
    2 PVAMC Portland Oregon United States 97239

    Sponsors and Collaborators

    • Oregon Health and Science University

    Investigators

    • Principal Investigator: Glenn M Eisen, MD, MPH, Oregon Health and Science University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT00591461
    Other Study ID Numbers:
    • IRB00003558
    First Posted:
    Jan 11, 2008
    Last Update Posted:
    Dec 11, 2019
    Last Verified:
    Dec 1, 2019
    Keywords provided by Oregon Health and Science University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 11, 2019