Biology in Patients With Reflux Esophagitis (BENCH)

Biology in Patients With Reflux Esophagitis and Mucosal Impedance

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.

Study Overview

• Status: Completed
• Conditions: GERD

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Digestive Diseases Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female volunteers ages 18 years and older; able to give informed consent; no use of acid suppressive therapy within 14 days prior to procedure; no history of Barret's esophagus, gastric surgery, alcoholism, or significant motility condition; no contraindications to biopsy, including taking anticoagulants or allergies to local anesthetic.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Controls; No complaints or history of heartburn or acid regurgitation; no erosion at EGD; and normal pH monitoring
GERD Cases; Patients with esophageal erosion at EGD and abnormal pH monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gene and protein expression due to acid exposure in the esophagus	We are assessing if acid exposure affects gene and protein expression in the esophageal/post-cricoid area tissue	Chronic exposure
Change in local impedance of the esophageal mucosa	We are assessing if acid exposure affects local impedance of the mucosa	Chronic exposure

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 31, 2010
• First Submitted That Met QC Criteria: August 31, 2010
• First Posted (Estimate): September 2, 2010

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: esophageal erosion; abnormal pH monitoring
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Diseases; Peptic Ulcer; Duodenal Diseases; Esophagitis, Peptic; Esophagitis
• Other Study ID Numbers: BENCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO