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

NCT ID: NCT01806220

Last Updated: 2015-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2007-12-31

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%.

Conditions

Gastroesophageal Reflux Disease; Chronic Laryngitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

biopsy of 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

Group Type: ACTIVE_COMPARATOR

Biopsy of the retrocrycoid laryngeal mucosa

Intervention Type: PROCEDURE

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

biopsy of distal esophagus mucosa

during upper digestive endoscopy a biopsy specimen of the distal esophageal mucosa was obtained

Intervention:biopsy of distal esophagus mucosa

Group Type: ACTIVE_COMPARATOR

Biopsy of the distal esophageal mucosa

Intervention Type: PROCEDURE

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

Interventions

Biopsy 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

Intervention Type: PROCEDURE

Biopsy 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faculdade de Ciências Médicas da Santa Casa de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

CLAUDIA ALESSANDRA ECKLEY

Professor Otolaryngology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

CLAUDIA A ECKLEY, MD

Role: PRINCIPAL_INVESTIGATOR

SANTA CASA SCHOOL OF MEDICINE AND HOSPITALS OF SÃO PAULO BRAZIL

Locations

Santa Casa School of Medicine and Hospitals of São Paulo Brazil

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Eckley CA, Michelsohn N, Rizzo LV, Tadokoro CE, Costa HO. Salivary epidermal growth factor concentration in adults with reflux laryngitis. Otolaryngol Head Neck Surg. 2004 Oct;131(4):401-6. doi: 10.1016/j.otohns.2004.01.020.

Reference Type: BACKGROUND

PMID: 15467608 (View on PubMed)

Eckley CA, Rios Lda S, Rizzo LV. Salivary egf concentration in adults with reflux chronic laryngitis before and after treatment: preliminary results. Braz J Otorhinolaryngol. 2007 Mar-Apr;73(2):156-60. doi: 10.1016/s1808-8694(15)31060-0.

Reference Type: BACKGROUND

PMID: 17589721 (View on PubMed)

Sarosiek J, McCallum RW. Do salivary organic components play a protective role in health and disease of the esophageal mucosa? Digestion. 1995;56 Suppl 1:32-7. doi: 10.1159/000201299.

Reference Type: BACKGROUND

PMID: 7556968 (View on PubMed)

Rourk RM, Namiot Z, Edmunds MC, Sarosiek J, Yu Z, McCallum RW. Diminished luminal release of esophageal epidermal growth factor in patients with reflux esophagitis. Am J Gastroenterol. 1994 Aug;89(8):1177-84.

Reference Type: BACKGROUND

PMID: 8053431 (View on PubMed)

Other Identifiers

fcmscsp180/06

Identifier Type: -

Identifier Source: org_study_id