Biology in Patients With Reflux Esophagitis

NCT ID: NCT01194323

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-12-31

Brief Summary

GERD is a common condition in the western world. In most cases, the diagnostic is established by good response to empiric proton pump inhibitor (PPI) therapy. When the patient symptoms are refractory to therapy, multiple invasive tests are available. The results of those tests (EGD, manometry, Ph monitoring and impedance) are clues that the physician use together to establish the diagnostic. No test however can be use alone because of their poor specificity and sensitivity. Recently, microscopy has been used to detect dilated intercellular space in between distal esophageal cells tissue; unfortunately this marker again failed to diagnose GERD.

In search of more sensitive and specific markers of GERD, we propose to assess if acid exposure affects: 1) gene and proteins expression in the esophageal/post-cricoid area tissue; and 2) local impedance of the mucosa. The secondary aim of this proposal is to determine if correlation exists between the two approaches.

Conditions

GERD

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Controls

No complaints or history of heartburn or acid regurgitation; no erosion at EGD; and normal pH monitoring

No interventions assigned to this group

GERD Cases

Patients with esophageal erosion at EGD and abnormal pH monitoring.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Male or female
• Ages 18 years or older
• Undergoing EGD as standard of care at Vanderbilt's Digestive Diseases Center
• Esophageal erosion detected at EGD
• Abnormal pH monitoring

• Male or female
• Ages 18 years or older
• Undergoing EGD as standard of care at Vanderbilt's Digestive Diseases Center
• No complaints or history o heartburn or acid regurgitation
• No erosion at EGD
• Normal pH monitoring

Exclusion Criteria

• Less than 18 years of age
• Unable to provide informed consent
• Use of acid suppressive therapy within last 14 days
• known history of Barrett's esophagus, gastric surgery, alcoholism, significant motility condition
• contraindications to biopsy such as taking anticoagulants other than aspirin (coumadin, plavix) or allergies to local anesthetic

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Vaezi

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Vaezi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Digestive Diseases Center

Nashville, Tennessee, United States

Countries

United States

References

Saritas Yuksel E, Higginbotham T, Slaughter JC, Mabary J, Kavitt RT, Garrett CG, Vaezi MF. Use of direct, endoscopic-guided measurements of mucosal impedance in diagnosis of gastroesophageal reflux disease. Clin Gastroenterol Hepatol. 2012 Oct;10(10):1110-6. doi: 10.1016/j.cgh.2012.05.018. Epub 2012 May 27.

Reference Type: DERIVED

PMID: 22642956 (View on PubMed)

Other Identifiers

BENCH

Identifier Type: -

Identifier Source: org_study_id