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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01204931

Enrollment

254

Registered

2010-09-17

Start date

2010-11-30

Completion date

2015-06-30

Last updated

2016-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Keywords

reflux, gastroesophageal reflux disease, GERD

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results