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

Completed

• Conditions: Gastroesophageal Reflux Disease

• Registration Number: NCT01204931
• Lead Sponsor: Vanderbilt University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Study Start: 2010-11
• Primary Completion: 2013-07
• Study Completion: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Vanderbilt University Medical Center GI Outpatient Clinic; 🇺🇸 Nashville, Tennessee, United States