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

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204931
• Other study ID #: GERD SISAP
• Status: Completed
• Phase: N/A
• First received: September 13, 2010
• Last updated: January 19, 2016
• Start date: November 2010
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: June 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center GI Outpatient Clinic	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No