Can We Predict Who Has Gastroesophageal Reflux Disease (GERD)?
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.
Gastroesophageal Reflux Disease
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||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|
- Symptom Index (SI) and Symptom Associated Probability (SAP) [ Time Frame: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring ] [ Designated as safety issue: No ]Assess the sensitivity and specificity of symptom association indices (SI and SAP)regarding gastroesophageal reflux disease (GERD)
- Predicting gastroesophageal reflux disease (GERD) [ Time Frame: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring ] [ Designated as safety issue: No ]Determine the best parameter for predicting gastroesophageal reflux disease (GERD) from a list of conventional pH measurement findings.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Gastroesophageal Reflux Disease (GERD) Cases
Erosive disease - presence of esophageal mucosal injuries documented endoscopically.
Non-erosive disease - normal esophagogastroduodenoscopy with symptoms
normal subjects without symptoms of gastroesophageal reflux disease (GERD)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204931
|United States, Tennessee|
|Vanderbilt University Medical Center GI Outpatient Clinic|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Michael Vaezi, MD, PhD||Vanderbilt University|