Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444145
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2007-03-05
Brief Title:
Do Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Predict Response to Treatment
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Do Laryngeal Biopsy Findings Predict Treatment Response in Suspected Laryngopharyngeal Reflux
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 reflux will have ultrastructural changes on a laryngeal biopsy which are predictors of 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
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 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 edemaerythema 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 PPIs 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 patients 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 patients 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
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 PPIs 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 patients 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None