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Biology in Patients With Reflux Esophagitis

Biology in Patients With Reflux Esophagitis and Mucosal Impedance

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01194323
Acronym
BENCH
Enrollment
75
Registered
2010-09-02
Start date
2010-11-30
Completion date
2012-12-31
Last updated
2017-04-04

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

Conditions

GERD

Keywords

esophageal erosion, abnormal pH monitoring

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.

Interventions

None listed

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

(GERD Cases): * 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 Inclusion Criteria (Controls): * 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

Design outcomes

Primary

MeasureTime frameDescription
Change in gene and protein expression due to acid exposure in the esophagusChronic exposureWe are assessing if acid exposure affects gene and protein expression in the esophageal/post-cricoid area tissue
Change in local impedance of the esophageal mucosaChronic exposureWe are assessing if acid exposure affects local impedance of the mucosa

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026