Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux
Completed · Phase 4
Conditions studied: Larynx Disease, Gastroesophageal Reflux
In brief
The purpose of the study is to determine whether patients with suspected Laryngopharyngeal reflux have inflammation and ultrastructural injury on their laryngeal biopsies.
Key facts
- Study ID
- NCT00373997
- Run by
- Vanderbilt University
- People needed
- 45
- Starts
- 2006-09-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2014-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410 — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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