Clinical trial NCT00573911: Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus
Official title: Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Barrett's Esophagus
GERD
Keywords: Barrett's esophagus
GERD
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2007-12-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: The specific aim of this proposal will be: To assess the association between acid reflux and subepithelial fibroblasts in Barrett's esophagus.
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Prasad G Iyer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: