Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis (EGFR)
18. mars 2015 oppdatert av: CLAUDIA ALESSANDRA ECKLEY, Faculdade de Ciências Médicas da Santa Casa de São Paulo
- 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
Studieoversikt
Status
Fullført
Detaljert beskrivelse
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%.
Studietype
Intervensjonell
Registrering (Faktiske)
24
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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São Paulo, Brasil, 01222-010
- Santa Casa School of Medicine and Hospitals of São Paulo Brazil
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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 |
Biopsies of the retrocrycoid laryngeal mucosa were performeed under sedation using a forceps introduced by the working channel of the endoscope
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Aktiv komparator: 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 |
Biopsies were performeed under sedation using a forceps introduced by the working channel of the endoscope during upper digestive endoscopy
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Epidermal Growth Factor Receptor (EGFR) expression in laryngeal and esophageal mucosa of patients with chronic reflux laryngitis
Tidsramme: 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
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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.
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Compare Epidermal Growth Factor Receptor expression in different severities of inflammatory responses.
Tidsramme: EGFR expression of the esophageal and laryngeal mucosas was compared to clinical, videolaryngoscopic and microscopic inflammatory signs. (up to 36 months)
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Mucosal biopsy specimens obtained during routine upper digestive tract endocopic examination under sedation were obtained.
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EGFR expression of the esophageal and laryngeal mucosas was compared to clinical, videolaryngoscopic and microscopic inflammatory signs. (up to 36 months)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: CLAUDIA A ECKLEY, MD, Santa Casa School of Medicine and Hospitals of São Paulo Brazil
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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].
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2004
Primær fullføring (Faktiske)
1. desember 2007
Studiet fullført (Faktiske)
1. desember 2007
Datoer for studieregistrering
Først innsendt
29. august 2012
Først innsendt som oppfylte QC-kriteriene
6. mars 2013
Først lagt ut (Anslag)
7. mars 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. mars 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. mars 2015
Sist bekreftet
1. mars 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- fcmscsp180/06
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