Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus

Mayo Clinic

Status and phase

Completed

Phase 1

Conditions

GERD

Barrett's Esophagus

Treatments

Procedure: Endoscopy and pH study

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00573911

IRUSESOM0546

07-002453

Details and patient eligibility

About

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.

Full description

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).

Enrollment

16 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment >/= 1 cms
Absence of dysplasia on prior biopsies
Laboratory studies:
- Prothrombin time (INR) < 1.5
- Hemoglobin > 8.0 gm/dL
Ability to provide informed consent

Exclusion criteria

Eastern Cooperative Oncology Group performance status 3 or 4
Inability to tolerate endoscopic procedures
Pregnancy: Females of child-bearing age will be screened with pregnancy test. Although none of the procedures in the study are contraindicated in pregnancy, sedation used in endoscopy can be contraindicated in early pregnancy
Prior esophageal surgery, or cancer