Biology in Patients With Reflux Esophagitis

NCT01194323 | Completed

• 1 other identifier: BENCH
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

esophageal erosion; abnormal pH monitoring

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Digestive Diseases Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 22642956 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Total RNA and proteins will be extracted from de-identified samples. Genes' and proteins' expression will be processed and analyzed at Vanderbilt Core Facilities.

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: August 31, 2010
• First Posted: September 2, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 4, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)