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Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00573911
First Posted: December 14, 2007
Last Update Posted: January 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic
  Purpose

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.


Condition Intervention Phase
Barrett's Esophagus GERD Procedure: Endoscopy and pH study Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus

Resource links provided by NLM:


Further study details as provided by Prasad G. Iyer, Mayo Clinic:

Primary Outcome Measures:
  • The specific aim of this proposal will be: To assess the association between acid reflux and subepithelial fibroblasts in Barrett's esophagus. [ Time Frame: end of study ]

Enrollment: 16
Study Start Date: August 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Endoscopy and pH study
    endoscopy and PH study done one time
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573911


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
AstraZeneca
Investigators
Principal Investigator: Prasad G Iyer, M.D. Mayo Clinic
  More Information

Responsible Party: Prasad G. Iyer, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00573911     History of Changes
Other Study ID Numbers: 07-002453
IRUSESOM0546
First Submitted: December 12, 2007
First Posted: December 14, 2007
Last Update Posted: January 17, 2013
Last Verified: January 2013

Keywords provided by Prasad G. Iyer, Mayo Clinic:
Barrett's esophagus
GERD

Additional relevant MeSH terms:
Barrett Esophagus
Gastroesophageal Reflux
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders