Barrett's Esophagus
Conditions
Keywords
Barrett's esophagus
Brief summary
The purpose of this study is to determine the association between acid reflux and cell changes in Barrett's esophagus. Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser degree of stromal activation. Specific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive BE epithelial proliferation.
Interventions
PROCEDURE24 hour pH study and upper endoscopy (EGD)
All subjects enrolled will undergo 24 hour pH followed by EGD.
Sponsors
National Institutes of Health (NIH)
Mayo Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment \>/= 1 cm 2. Absence of dysplasia or LGD on biopsies within the past 5 years 3. Ability to provide informed consent 4. Age between 18 years and 90 years at study entry.
Exclusion criteria
1. Eastern Cooperative Oncology Group performance status 3 or 4 2. Inability to tolerate endoscopic procedures 3. Pregnancy: Females of child-bearing age will be screened with pregnancy test. 4. Prior esophageal surgery, or cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| activated myofibroblasts | 6 months | The primary end point for the study will be the proportion of patients with activated myofibroblasts (defined as positive staining for SMA and vimentin with negative staining for Desmin, in \> 50% of subepithelial myofibroblasts). This primary end point will be compared between the group with controlled acid reflux and the group without acid reflux. |
Countries
United States
Outcome results
None listed