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

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ClinicalTrials.gov Identifier: NCT01204931
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Vaezi, 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.

Condition or disease
Gastroesophageal Reflux Disease

Study Type : Observational
Actual Enrollment : 254 participants
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
Study Start Date : November 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Group/Cohort
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)



Primary Outcome Measures :
  1. Symptom Index (SI) and Symptom Associated Probability (SAP) [ Time Frame: 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)

  2. Predicting gastroesophageal reflux disease (GERD) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204931


Locations
United States, Tennessee
Vanderbilt University Medical Center GI Outpatient Clinic
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Michael Vaezi, MD, PhD Vanderbilt University Medical Center

Responsible Party: Michael Vaezi, Medical Director, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01204931     History of Changes
Other Study ID Numbers: GERD SISAP
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: September 2015

Keywords provided by Michael Vaezi, Vanderbilt University:
reflux
gastroesophageal reflux disease
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases