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

NCT01204931 | Completed

• 1 other identifier: GERD SISAP
• Study Type: observational
• Target: 254
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

reflux; gastroesophageal reflux disease; GERD

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Gastroesophageal Reflux Disease (GERD) Cases

Erosive disease - presence of esophageal mucosal injuries documented endoscopically. Non-erosive disease - normal esophagogastroduodenoscopy with symptoms

Control Group

normal subjects without symptoms of gastroesophageal reflux disease (GERD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult subjects presenting to Vanderbilt University Medical Center Gastroenterology outpatient clinic with symptoms consistent with gastroesophageal reflux disease (GERD)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center GI Outpatient Clinic

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Michael Vaezi, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 17, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: June 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2015-09

Locations

US (1)