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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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%.
Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo

Current Primary Outcome: 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 ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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) ]

Mucosal biopsy specimens obtained during routine upper digestive tract endocopic examination under sedation were obtained.


Original Secondary Outcome: Same as current

Information By: Faculdade de Ciências Médicas da Santa Casa de São Paulo

Dates:
Date Received: August 29, 2012
Date Started: January 2004
Date Completion:
Last Updated: March 18, 2015
Last Verified: March 2015