Completed

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

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What is being tested

Biopsy of the retrocrycoid laryngeal mucosa

+ Biopsy of the distal esophageal mucosa

Procedure
Who is being recruted

Deglutition Disorders+3

+ Digestive System Diseases

+ Esophageal Diseases

From 20 to 80 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorFaculdade de Ciências Médicas da Santa Casa de São Paulo
Last updated: March 20, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2004

Actual date on which the first participant was enrolled.

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%.

NCT01806220
Principal SponsorFaculdade de Ciências Médicas da Santa Casa de São Paulo
Last updated: March 20, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Deglutition DisordersDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesEsophageal Motility DisordersGastroesophageal Reflux

Criteria

2 inclusion criteria required to participate
A positive 24-hour doube probe esophageal ph monitoring test
Adults with reflux laryngitis diagnosed by clinical symptoms (Reflux Symptom -Index > 13) and videolaryngoscopic signs (Reflux Finding Score > 7)
2 exclusion criteria prevent from participating
Current or past history of Head and Neck or digestive tract tumors
Other known causes of chronic laryngitis or inflammatory conditions of the pharynx, larynx and upper digestive tract

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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

Group II

Active Comparator
during upper digestive endoscopy a biopsy specimen of the distal esophageal mucosa was obtained Intervention:biopsy of distal esophagus mucosa

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Santa Casa School of Medicine and Hospitals of São Paulo Brazil

São Paulo, BrazilOpen Santa Casa School of Medicine and Hospitals of São Paulo Brazil in Google Maps
CompletedOne Study Center