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

Not Applicable

Completed

• Conditions: Chronic Laryngitis; Gastroesophageal Reflux Disease
• Interventions: Procedure: Biopsy of the distal esophageal mucosa; Procedure: Biopsy of the retrocrycoid laryngeal mucosa

• Registration Number: NCT01806220
• Lead Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo

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%.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
biopsy of distal esophagus mucosa	Biopsy of the distal esophageal mucosa	during upper digestive endoscopy a biopsy specimen of the distal esophageal mucosa was obtained Intervention:biopsy of distal esophagus mucosa
biopsy of retrocrycoid laryngeal mucosa	Biopsy of the retrocrycoid laryngeal mucosa	During upper digestive endoscopy a biopsy specimen of the retrocrycoid laryngeal mucosa was obtained with a forceps introduced by the working channel of the scope. Intervention: biopsy of retrocrycoid laryngeal mucosa

Primary Outcome Measures

Name	Time	Method
Epidermal Growth Factor Receptor (EGFR) expression in laryngeal and esophageal mucosa of patients with chronic reflux laryngitis	prospective study that enrolled every adult patient with reflux laryngitis and no other causes of chronic laryngeal and pharyngeal inflammation during a 36 month period	Patients 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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Santa Casa School of Medicine and Hospitals of São Paulo Brazil; 🇧🇷 São Paulo, Brazil