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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CLAUDIA ALESSANDRA ECKLEY, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier:
NCT01806220
First received: August 29, 2012
Last updated: March 6, 2013
Last verified: March 2013
  Purpose
  • 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

Condition Intervention
Gastroesophageal Reflux Disease (GERD)
Chronic Laryngitis
Procedure: Biopsy of the retrocrycoid laryngeal mucosa
Procedure: Biopsy of the distal esophageal mucosa

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis

Resource links provided by NLM:


Further study details as provided by Faculdade de Ciências Médicas da Santa Casa de São Paulo:

Primary Outcome Measures:
  • Epidermal Growth Factor Receptor (EGFR) expression in laryngeal and esophageal mucosa of patients with chronic reflux laryngitis [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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:
  • Compare Epidermal Growth Factor Receptor expression in different severities of inflammatory responses. [ Time Frame: EGFR expression of the esophageal and laryngeal mucosas was compared to clinical, videolaryngoscopic and microscopic inflammatory signs. (up to 36 months) ] [ Designated as safety issue: No ]
    Mucosal biopsy specimens obtained during routine upper digestive tract endocopic examination under sedation were obtained.


Enrollment: 24
Study Start Date: January 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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

Procedure: 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
Active Comparator: 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

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

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%.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806220

Locations
Brazil
Santa Casa School of Medicine and Hospitals of São Paulo Brazil
São Paulo, Brazil, 01222-010
Sponsors and Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Investigators
Principal Investigator: CLAUDIA A ECKLEY, MD SANTA CASA SCHOOL OF MEDICINE AND HOSPITALS OF SÃO PAULO BRAZIL
  More Information

Publications:
Responsible Party: CLAUDIA ALESSANDRA ECKLEY, Professor Otolaryngology Department, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT01806220     History of Changes
Other Study ID Numbers: fcmscsp180/06
Study First Received: August 29, 2012
Last Updated: March 6, 2013
Health Authority: Brazil: Ministry of Health

Keywords provided by Faculdade de Ciências Médicas da Santa Casa de São Paulo:
Gastroesophageal Reflux Disease (GERD)
Chronic Laryngitis
Epidermal Growth factor receptor

Additional relevant MeSH terms:
Gastroesophageal Reflux
Laryngitis
Chronic Disease
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014