Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis (EGFR)
Primary Purpose
Gastroesophageal Reflux Disease, Chronic Laryngitis
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Biopsy of the retrocrycoid laryngeal mucosa
Biopsy of the distal esophageal mucosa
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal Reflux Disease (GERD), Chronic Laryngitis, Epidermal Growth factor receptor
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.
Sites / Locations
- Santa Casa School of Medicine and Hospitals of São Paulo Brazil
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
biopsy of retrocrycoid laryngeal mucosa
biopsy of distal esophagus mucosa
Arm Description
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
during upper digestive endoscopy a biopsy specimen of the distal esophageal mucosa was obtained Intervention:biopsy of distal esophagus mucosa
Outcomes
Primary Outcome Measures
Epidermal Growth Factor Receptor (EGFR) expression in laryngeal and esophageal mucosa of patients with chronic reflux laryngitis
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.
Mucosal biopsy specimens obtained during routine upper digestive tract endocopic examination under sedation were obtained.
Full Information
NCT ID
NCT01806220
First Posted
August 29, 2012
Last Updated
March 18, 2015
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01806220
Brief Title
Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis
Acronym
EGFR
Official Title
Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Chronic Laryngitis
Keywords
Gastroesophageal Reflux Disease (GERD), Chronic Laryngitis, Epidermal Growth factor receptor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
biopsy of retrocrycoid laryngeal mucosa
Arm Type
Active Comparator
Arm Description
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
Arm Title
biopsy of distal esophagus mucosa
Arm Type
Active Comparator
Arm Description
during upper digestive endoscopy a biopsy specimen of the distal esophageal mucosa was obtained
Intervention:biopsy of distal esophagus mucosa
Intervention Type
Procedure
Intervention Name(s)
Biopsy of the retrocrycoid laryngeal mucosa
Intervention Description
Biopsies of the retrocrycoid laryngeal mucosa were performeed under sedation using a forceps introduced by the working channel of the endoscope
Intervention Type
Procedure
Intervention Name(s)
Biopsy of the distal esophageal mucosa
Intervention Description
Biopsies were performeed under sedation using a forceps introduced by the working channel of the endoscope during upper digestive endoscopy
Primary Outcome Measure Information:
Title
Epidermal Growth Factor Receptor (EGFR) expression in laryngeal and esophageal mucosa of patients with chronic reflux laryngitis
Description
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.
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
Secondary Outcome Measure Information:
Title
Compare Epidermal Growth Factor Receptor expression in different severities of inflammatory responses.
Description
Mucosal biopsy specimens obtained during routine upper digestive tract endocopic examination under sedation were obtained.
Time Frame
EGFR expression of the esophageal and laryngeal mucosas was compared to clinical, videolaryngoscopic and microscopic inflammatory signs. (up to 36 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CLAUDIA A ECKLEY, MD
Organizational Affiliation
SANTA CASA SCHOOL OF MEDICINE AND HOSPITALS OF SÃO PAULO BRAZIL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Casa School of Medicine and Hospitals of São Paulo Brazil
City
São Paulo
ZIP/Postal Code
01222-010
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
15467608
Citation
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. Erratum In: Otolaryngol Head Neck Surg. 2005 Feb;132(2):344. Tadakoro, Carlos Eduardo [corrected to Tadokoro, Carlos Eduardo].
Results Reference
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PubMed Identifier
17589721
Citation
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.
Results Reference
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PubMed Identifier
7556968
Citation
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.
Results Reference
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PubMed Identifier
8053431
Citation
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.
Results Reference
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Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis
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