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

Barrett's Esophagus Clinical Trial

— CR20  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01281618
• Other study ID #: 07-004899
• Status: Completed
• Phase: N/A
• First received: January 20, 2011
• Last updated: May 3, 2013
• Start date: October 2008
• Est. completion date: June 2011

Study information

• Verified date: May 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Procedure:
• 24 hour pH study and upper endoscopy (EGD)
All subjects enrolled will undergo 24 hour pH followed by EGD.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	activated myofibroblasts	The primary end point for the study will be the proportion of patients with activated myofibroblasts (defined as positive staining for SMA and vimentin with negative staining for Desmin, in > 50% of subepithelial myofibroblasts). This primary end point will be compared between the group with controlled acid reflux and the group without acid reflux.	6 months	No