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

NCT01806220 | Completed DMC

• 1 other identifier: fcmscsp180/06
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Gastroesophageal Reflux Disease; Chronic Laryngitis

Keywords

Gastroesophageal Reflux Disease (GERD); Chronic Laryngitis; Epidermal Growth factor receptor

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• Compare Epidermal Growth Factor Receptor expression in different severities of inflammatory responses.

  EGFR expression of the esophageal and laryngeal mucosas was compared to clinical, videolaryngoscopic and microscopic inflammatory signs. (up to 36 months)

Study Arms (2)

biopsy of retrocrycoid laryngeal mucosa

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

Procedure: Biopsy of the retrocrycoid laryngeal mucosa

biopsy of distal esophagus mucosa

ACTIVE COMPARATOR

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

Interventions

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 retrocrycoid laryngeal mucosa

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

biopsy of distal esophagus mucosa

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculdade de Ciências Médicas da Santa Casa de São Paulo: lead

Study Sites (1)

Santa Casa School of Medicine and Hospitals of São Paulo Brazil

São Paulo, São Paulo, 01222-010, Brazil

Location

Related Publications (4)

• 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.

  PMID: 15467608 BACKGROUND

• 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.

  PMID: 17589721 BACKGROUND

• 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.

  PMID: 7556968 BACKGROUND

• 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.

  PMID: 8053431 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• CLAUDIA A ECKLEY, MD

  SANTA CASA SCHOOL OF MEDICINE AND HOSPITALS OF SÃO PAULO BRAZIL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Otolaryngology Department

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: March 7, 2013
• Study Start: January 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 20, 2015

Record last verified: 2015-03

Locations

BR (1)