Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus (CR20)

Mayo Clinic

Status: Completed

Conditions: Barrett's Esophagus

Treatments: Procedure: 24 hour pH study and upper endoscopy (EGD)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01281618

07-004899

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

48 participants in 1 patient group

Those with barrett's esophagus

Description:

Those with barrett's esophagus: no dysplasia or low grade dysplasia

Treatment:

Procedure: 24 hour pH study and upper endoscopy (EGD)