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| ID | Type | Description | Link |
|---|---|---|---|
| IRUSESOM0546 |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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:
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopy and pH study | Procedure | endoscopy and PH study done one time |
| Measure | Description | Time Frame |
|---|---|---|
| The specific aim of this proposal will be: To assess the association between acid reflux and subepithelial fibroblasts in Barrett's esophagus. | end of study |
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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:
Ability to provide informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prasad G Iyer, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| D004066 |
| Digestive System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D013514 | Surgical Procedures, Operative |