GERD Clinical Trial
Official title:
Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus
Patients with Barrett's Esophagus are known to have excessive distal esophageal acid
exposure comparable to patients with erosive esophagitis. A significant proportion of
patients with BE who are not symptomatic on treatment continue to have persistent acid
reflux. High dose esomeprazole is able to control acid reflux in patients with BE. The
effect of acid reflux on Barrett's esophagus stroma is currently unknown.
It is our hypothesis that stromal fibroblast activation in Barrett's esophagus is influenced
by acid reflux. The specific aim of this proposal will be: To assess the association between
acid reflux and subepithelial fibroblasts in Barrett's esophagus.
We will conduct a prospective cohort study to assess the degree of stromal activation in
patients with LSBE (without dysplasia) who have adequate and inadequate control of acid
reflux in the distal esophagus. The study will be conducted in two phases.
Phase 1 (Pilot): 20 patients with LSBE without dysplasia will undergo endoscopy with
biopsies and a 24 hour pH study on treatment. Patients will then be divided into 2 groups:
- Group A (GER): Those with ongoing acid reflux (characterized by either presence of
esophagitis [LA classification B,C or D1] on endoscopy, and/or a positive pH study on
treatment defined using standard criteria)
- Group B (NGER): Those with controlled acid reflux (negative endoscopy and pH study on
treatment).
Stromal markers that will be assessed and compared between the 2 groups will include:
presence of activated myofibroblasts (detected by immunohistochemistry for vimentin and
smooth muscle actin).
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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