Do Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Predict Response to Treatment?

Completed · Phase 4

Conditions studied: Larynx Disease, Gastroesophageal Reflux

In brief

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.

Key facts

Study ID

NCT00444145

Run by

Vanderbilt University Medical Center

People needed

38

Starts

2007-03-01

Expected to finish

2009-12-01

Last updated by the study team

2017-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

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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