Can We Predict Who Has Gastroesophageal Reflux Disease (GERD)?

Study Overview
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Brief Summary
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Gastroesophageal reflux disease (GERD) is currently defined as a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications. Doctors often diagnose and treat GERD based on symptoms of heartburn and regurgitation. In recent years, the prevalence of partial or non-response to Proton Pump Inhibitors (PPI) has increased resulting in diagnostic testing with esophagogastroduodenoscopy (EGD) or ambulatory pH monitoring. Most patients do not have endoscopic evidence for reflux. Thus, in this group pH monitoring has emerged as an important physiologic test to determine the degree of esophageal acid exposure and to assess the association between patients' persistent symptoms and acid reflux events. The aims of this study are to assess the sensitivity and specificity of symptom associated indices and determine the best parameter for predicting GERD from a list of conventional pH measurement findings.

Official Title
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Can We Predict Who Has GERD? Systematic Evaluation of Role of pH Monitoring and the Specific Physiologic pH Parameters in Defining GERD, Bravo, Impedence and SISAP

Conditions
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Gastroesophageal Reflux Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects ages 18 or older Presenting to the Vanderbilt GI outpatient clinic with symptoms of GERD Undergoing upper endoscopy and wireless pH monitoring (standard of care) Erosive disease: presence of esophageal mucosal injuries documented Non-erosive disease: normal esophagogastroduodenoscopy (EGD) with symptoms Control group: normal subjects without symptoms of GERD Exclusion Criteria: Anti-reflux therapy within 7 days prior to the pH study Previous neck, esophagus, or stomach surgery Major motility disorders Previous neck, esophagus, or stomach cancer or radiations

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastroesophageal Reflux Disease (GERD) Cases<br>Erosive disease - presence of esophageal mucosal injuries documented endoscopically. Non-erosive disease - normal esophagogastroduodenoscopy with symptoms | |
| Control Group<br>normal subjects without symptoms of gastroesophageal reflux disease (GERD) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Index (SI) and Symptom Associated Probability (SAP) | Assess the sensitivity and specificity of symptom association indices (SI and SAP)regarding gastroesophageal reflux disease (GERD) | Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring | 
| Predicting gastroesophageal reflux disease (GERD) | Determine the best parameter for predicting gastroesophageal reflux disease (GERD) from a list of conventional pH measurement findings. | Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reflux, gastroesophageal reflux disease, GERD