Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis (EGFR)
|ClinicalTrials.gov Identifier: NCT01806220|
Recruitment Status : Completed
First Posted : March 7, 2013
Last Update Posted : March 20, 2015
- 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 or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease Chronic Laryngitis||Procedure: Biopsy of the retrocrycoid laryngeal mucosa Procedure: Biopsy of the distal esophageal mucosa||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806220
|Santa Casa School of Medicine and Hospitals of São Paulo Brazil|
|São Paulo, Brazil, 01222-010|
|Principal Investigator:||CLAUDIA A ECKLEY, MD||SANTA CASA SCHOOL OF MEDICINE AND HOSPITALS OF SÃO PAULO BRAZIL|