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

Completed

• Conditions: Barrett's Esophagus
• Interventions: Procedure: 24 hour pH study and upper endoscopy (EGD)

• Registration Number: NCT01281618
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-20
• Study First Posted: 2011-01-24
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-03
• Last Update Posted: 2013-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Those with barrett's esophagus	24 hour pH study and upper endoscopy (EGD)	Those with barrett's esophagus: no dysplasia or low grade dysplasia

Primary Outcome Measures

Name	Time	Method
activated myofibroblasts	6 months	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States