Gastroesophageal Reflux Clinical Trial
Official 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.
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) reflux, or laryngopharyngeal reflux (LPR). GERD was first described to be a
causative agent in developing contact ulcers of the larynx (8), and since this early report
other routinely observed laryngeal signs are now attributed to LPR. These include laryngeal
edema/erythema, vocal cord granulomas and polyps, posterior cricoid cobblestoning,
interarytenoid changes, and subglottic stenosis. In addition, patient symptoms attributed to
LPR include hoarseness, sore or burning throat, chronic cough, throat clearing, globus,
nocturnal laryngospasm, otalgia, post-nasal drip, and dysphagia.
GERD occurs in 7% - 25% of the population on a daily or monthly basis, respectively (9). It
is estimated that up to 10% of patients presenting to ENT physicians do so because of
complaints that are thought to be related to LPR (2).
The current management of patients with suspected LPR complaints include either 1. empiric
therapy using proton pump inhibitors (PPI's) or 2. Ambulatory 24-hour pH monitoring to test
for GERD before beginning treatment. Because of the uncertainty and subjectivity of the ENT
laryngeal examination in diagnosing LPR, both algorithms fall short of ideal in treating
these patients. In a recent review of the literature, remarkably, up to 50% of patients with
laryngoscopic signs suggesting LPR do not respond to aggressive acid suppression and do not
have abnormal esophageal acid reflux values on pH testing (10). Yet, in this subset of
patients LPR continues to be implicated as the probable etiology of the patient's laryngeal
signs and symptoms.
Calabrese, et al. recently looked at the reversibility of GERD related ultrastructural
alterations in the esophagus using a PPI. Lower esophageal biopsies were analyzed with
electron microscopy (EM) for ultrastructural alterations attributed to GERD; that is,
dilation of intracellular spaces. Patients were then treated with a PPI and re-biopsied for
analysis of any changes of healing that may have occurred in these ultrastructural
alterations. Not surprisingly, the ultrastructural alterations showed complete recovery
(reduction of dilated intracellular spaces) after treatment with a PPI. Additionally
resolution of patient's symptoms coincided with recovery of ultrastructural alterations
(11). No such biopsies looking for LPR related changes in the larynx have ever been
performed in human subjects. Our initial study which is also submitted for review will
provide data on the prevalence of biopsy findings in controls, GERD and LPR patients.
Subsequent to this prevalence study, the importance of these findings will be assessed based
to determine if these findings will predict response to acid suppressive therapy.
In sum, LPR is an extremely subjective diagnosis, in which nearly half of all patients do
not have an abnormal 24hr pH study, nor do they respond to the standard GERD therapy of acid
suppression. Finding an alternative objective criterion for GERD induced laryngitis would be
an important clinical discovery. To date, there are no data on microscopic changes in the
larynx of patients suspected of having LPR. The most important question which this protocol
will address is if laryngeal findings specifically by either routine microscopy or electron
microscopy would predict response to PPI therapy. This would then result in being able to
identify GERD related laryngitis from non-GERD related causes.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05561179 -
Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease
|
N/A | |
Withdrawn |
NCT02213887 -
Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications
|
Phase 4 | |
Completed |
NCT01946971 -
Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)
|
Phase 1/Phase 2 | |
Recruiting |
NCT01825473 -
Study of Erythromycin in GER-Associated Apnea of the Newborn
|
N/A | |
Completed |
NCT00614536 -
Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period
|
Phase 4 | |
Completed |
NCT00365300 -
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
|
Phase 3 | |
Completed |
NCT00284908 -
Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00373997 -
Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux
|
Phase 4 | |
Completed |
NCT00567021 -
German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms
|
N/A | |
Completed |
NCT00141960 -
Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
|
Phase 2/Phase 3 | |
Completed |
NCT00291746 -
Validation of RDQ Questionnaire
|
Phase 4 | |
Completed |
NCT00215787 -
Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease
|
N/A | |
Completed |
NCT00226044 -
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
|
Phase 3 | |
Completed |
NCT01167543 -
Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease
|
N/A | |
Completed |
NCT00181805 -
Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
|
||
Completed |
NCT01048840 -
Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
|
||
Terminated |
NCT01281553 -
A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
|
Phase 4 | |
Completed |
NCT05486169 -
Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
|
N/A | |
Completed |
NCT04034017 -
Gastroesophageal Reflux Disease Among College Students
|
||
Terminated |
NCT03226054 -
Determining Risk Factors for Successful PPI Weaning
|
N/A |