Gastroesophageal Reflux Clinical Trial
— biopsy IIOfficial title:
Do Laryngeal Biopsy Findings Predict Treatment Response in Suspected Laryngopharyngeal Reflux
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
reflux, will have ultrastructural changes on a laryngeal biopsy which are predictors of
response to therapy.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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 Criteria: - 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. |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410 | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dilation of intracellular spaces 3 months after therapy | 3 months | Yes |
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