Skip to content

Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis

Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01806220
Acronym
EGFR
Enrollment
24
Registered
2013-03-07
Start date
2004-01-31
Completion date
2007-12-31
Last updated
2015-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Laryngitis, Gastroesophageal Reflux Disease

Keywords

Gastroesophageal Reflux Disease (GERD), Chronic Laryngitis, Epidermal Growth factor receptor

Brief summary

* Saliva plays an important role in the homeostasis of the digestive tract mucosa. * Salivary organic components, such as the Epidermal Growth Factor(EGF) have been found in defficient concentrations in patients with gastroesophageal reflux disease (GERD) and reflux related laryngitis (LPR). * The epidermal growth factor receptor (EGFR) signaling pathway is one of the most important pathways that regulate growth, survival, proliferation, and differentiation in mammalian cells * Eperdermal growth factor receptor (EGFR) overexpression has been linked to hyperproliferative diseases. * It is unknown if the inflammatory process in GERD is realated to difficiencies in EGFR expression. * The objective of the current study was to try to establish a correlation between the expression of EGFR in the laryngeal and esophageal mucosa and the severity of laryngitis in adults with GERD and LPR

Detailed description

Objectives: The expression of the Epidermal Growth Factor receptor (EGFR) has been studied in a number of neoplastic and chronic diseases, but there are no reports in literature regarding its expression in chronic laryngitis associated to Gastroesophageal Reflux isease (GERD), also known as Laryngopharyngeal Reflux (LPR). The current study compared the expression of EGFR in the esophageal and laryngeal mucosa of adults with GERD and LPR. Study Design: Prospective based on imunohistochemical analysis of parafine embedded biopsy specimens and clinical data. Methods: From August, 2004 to February 2007 a total of 24 adults with confirmed diagnosis of LPR and no other clinical conditions or habits known to cause chronic laryngitis were studied at a University Hospital. Biopsies of the distal esophagus and the retrocrycoid laryngeal mucosa were obtained during upper digestive endoscopy. Data were analyzed statistically comparing samples in each individual and between individuals using the severity of histological signs of inflammation on hematoxacillin and eosinophillin (HE) stains to immunohistochemical analysis of the expression of EGFR. Other independent variables were severity of symptoms and signs, gender and age. Fishers´s exact test and multivariance ANOVA tests were used with significance level established at 95%.

Interventions

PROCEDUREBiopsy of the retrocrycoid laryngeal mucosa

Biopsies of the retrocrycoid laryngeal mucosa were performeed under sedation using a forceps introduced by the working channel of the endoscope

PROCEDUREBiopsy of the distal esophageal mucosa

Biopsies were performeed under sedation using a forceps introduced by the working channel of the endoscope during upper digestive endoscopy

Sponsors

Faculdade de Ciências Médicas da Santa Casa de São Paulo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Adults with reflux laryngitis diagnosed by clinical symptoms (Reflux Symptom -Index \>13) and videolaryngoscopic signs (Reflux Finding Score \>7) * A positive 24-hour doube probe esophageal ph monitoring test

Exclusion criteria

* Other known causes of chronic laryngitis or inflammatory conditions of the pharynx, larynx and upper digestive tract. * Current or past history of Head and Neck or digestive tract tumors.

Design outcomes

Primary

MeasureTime frameDescription
Epidermal Growth Factor Receptor (EGFR) expression in laryngeal and esophageal mucosa of patients with chronic reflux laryngitisprospective study that enrolled every adult patient with reflux laryngitis and no other causes of chronic laryngeal and pharyngeal inflammation during a 36 month periodPatients with reflux laryngitis diagnosed by suggestive symptoms (Reflux Symptom Index\>13) and videolaryngoscopic signs (Reflux Finding Score\>7) and confirmed by a 24-hour double probe esophageal ph monitoring test were consecutively enrolled properly informed and consented.

Secondary

MeasureTime frameDescription
Compare Epidermal Growth Factor Receptor expression in different severities of inflammatory responses.EGFR expression of the esophageal and laryngeal mucosas was compared to clinical, videolaryngoscopic and microscopic inflammatory signs. (up to 36 months)Mucosal biopsy specimens obtained during routine upper digestive tract endocopic examination under sedation were obtained.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026