Status:
COMPLETED
Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux
Lead Sponsor:
Vanderbilt University
Conditions:
Larynx Disease
Gastroesophageal Reflux
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to determine whether patients with suspected Laryngopharyngeal reflux have inflammation and ultrastructural injury on their laryngeal biopsies.
Detailed Description
Gastroesophageal reflux disease (GERD) has been implicated, in part, as the cause of various laryngeal signs and symptoms (1-7). This is often termed reflux laryngitis, ear, nose, and throat (ENT) ref...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- GERD 1. Documented erosive esophagitis (Patients will be newly diagnosed with esophageal erosion at initial visit via esophagogastroduodenoscopy \[EGD\]) 2.Patients with non-erosive esophagitis who have been responsive to PPI
- LPR 1. Diagnosed via Head \& Neck Institute endoscopists (i.e. patients will be newly diagnosed at initial visit via laryngoscopy)
- Controls
- No complaints or history of heartburn, acid regurgitation, atypical chest pain
- Never been seen by GI or ENT for related symptoms
- No prior therapy for GERD
- Have a medical condition other than reflux for which they need to undergo EGD. These conditions can be diarrhea, peptic ulcer disease, malabsorption, anemia, and dysphagia.
- Exclusion Criteria
- Age \< 18yrs
- Pregnancy
- Patients with contra-indications for EGD
- Use of antacid (PPI, H2RB) within last 30 days
- Use of any/all medications affecting gastrointestinal motility
- Known history of: Barrett's esophagus, Peptic stricture, Pyloric stenosis, Gastric resection
- Patients unable to give informed consent
- Patients unable to comply with follow-up
- Contraindications to biopsy: Taking anticoagulants other than aspirin (Coumadin, Plavix) or allergies to local anesthetic.
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00373997
Start Date
September 1 2006
End Date
December 1 2009
Last Update
May 1 2014
Active Locations (1)
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1
Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410
Nashville, Tennessee, United States, 37232-5280