Status:
COMPLETED
Do Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Predict Response to Treatment?
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Larynx Disease
Gastroesophageal Reflux
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to determine if tissue changes are predictor of clinical response to therapy. The hypothesis is that the patients who have laryngeal signs and symptoms related to acid ref...
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
- GERD
- Documented erosive esophagitis:
- Patients will be newly diagnosed with esophageal erosion at initial visit via EGD
- Patients with non-erosive esophagitis who have been responsive to PPI
- LPR
- Diagnosed via Head \& Neck Institute endoscopists:
- pts with chronic (\> 3-months) history of hoarseness, throat clearing, sore- or burning throat and globus
- Documentation of LPR using Larynx/Pharynx exam.
- This group is commonly evaluated at the Vanderbilt Voice Center.
Exclusion
- Age \< 18yrs
- Pregnancy
- Patients with contra-indications for EGD
- Patients on corticosteroids
- Active smokers
- Patients with a history of regular (\> 2 /day) alcohol use.
- 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
- Patients with known contraindication to lansoprazole.
- Contraindications to biopsy: Taking anticoagulants other than aspirin (Coumadin, Plavix) or allergic to the local anesthetics.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00444145
Start Date
March 1 2007
End Date
December 1 2009
Last Update
March 29 2017
Active Locations (1)
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1
Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410
Nashville, Tennessee, United States, 37232-5280