Biology in Patients With Reflux Esophagitis

Study Overview
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Brief Summary
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GERD is a common condition in the western world. In most cases, the diagnostic is established by good response to empiric proton pump inhibitor (PPI) therapy. When the patient symptoms are refractory to therapy, multiple invasive tests are available. The results of those tests (EGD, manometry, Ph monitoring and impedance) are clues that the physician use together to establish the diagnostic. No test however can be use alone because of their poor specificity and sensitivity. Recently, microscopy has been used to detect dilated intercellular space in between distal esophageal cells tissue; unfortunately this marker again failed to diagnose GERD. In search of more sensitive and specific markers of GERD, we propose to assess if acid exposure affects: 1) gene and proteins expression in the esophageal/post-cricoid area tissue; and 2) local impedance of the mucosa. The secondary aim of this proposal is to determine if correlation exists between the two approaches.

Official Title
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Biology in Patients With Reflux Esophagitis and Mucosal Impedance

Conditions
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GERD

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (GERD Cases): Male or female Ages 18 years or older Undergoing EGD as standard of care at Vanderbilt's Digestive Diseases Center Esophageal erosion detected at EGD Abnormal pH monitoring Inclusion Criteria (Controls): Male or female Ages 18 years or older Undergoing EGD as standard of care at Vanderbilt's Digestive Diseases Center No complaints or history o heartburn or acid regurgitation No erosion at EGD Normal pH monitoring Exclusion Criteria: Less than 18 years of age Unable to provide informed consent Use of acid suppressive therapy within last 14 days known history of Barrett's esophagus, gastric surgery, alcoholism, significant motility condition contraindications to biopsy such as taking anticoagulants other than aspirin (coumadin, plavix) or allergies to local anesthetic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Controls<br>No complaints or history of heartburn or acid regurgitation; no erosion at EGD; and normal pH monitoring | |
| GERD Cases<br>Patients with esophageal erosion at EGD and abnormal pH monitoring. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gene and protein expression due to acid exposure in the esophagus | We are assessing if acid exposure affects gene and protein expression in the esophageal/post-cricoid area tissue | Chronic exposure | 
| Change in local impedance of the esophageal mucosa | We are assessing if acid exposure affects local impedance of the mucosa | Chronic exposure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal erosion, abnormal pH monitoring