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Completed

NCT Number: NCT01806220

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

* 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

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Key information

Conditions

Gastroesophageal Reflux Disease Chronic Laryngitis Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Casa School of Medicine and Hospitals of São Paulo Brazil

São Paulo, 01222-010, Brazil

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biopsy of the retrocrycoid laryngeal mucosa

Procedure

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

Biopsy of the distal esophageal mucosa

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Other

Registry information

Acronym: EGFR

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Mar 7, 2013
Registry last updated
Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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