- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02035735
Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers
Usefulness of Narrow-band Imaging to Estimate the Superficial Spread of Squamous Cell Carcinomas in Oropharynx, Hypopharynx and Larynx
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Several studies have already showed the interest of the use of NBI for the early diagnosis of malignancies of the upper aerodigestive tract. For all tumors, the most accurate evaluation of its limits is very important to perform the best strategy of treatment. If surgery seems to be the best option, surgical margins must be widely healthy. Despite the systematic transnasal flexible endoscopy with white lamp followed by laryngoscopy under general anesthesia (LGA) and tomodensitometric evaluation, surgical margins can be unhealthy (in situ carcinoma or dysplasia). We propose to evaluate if the use of the NBI could be useful to determine the superficial spread of squamous cell carcinomas in these locations.
To April 2013 to Mars 2015, all patients with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx and whom a LGA are expected, are included. The day before the LGA, two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light and the second one with NBI. All results are noted on a schema. Superficial extension or synchronous lesions showed by NBI are analysed and compared with with lamp technic.
After surgery, surgical margins were evaluated and healthy margins were measured.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Toulouse, Frankrike, 31059
- University of Toulouse
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients who can benefit a laryngoscopic exam under general anesthesia
Exclusion Criteria:
- General anesthesia contra-indications
- Local anesthesia allergy
- Breast-feeding period or pregnancy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Videoendoscopy with WL and NBI
The day before the laryngoscopy under general anesthesia (LGA), two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light (WL) and the second one with NBI (NBI).
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For each patient with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx for whom a laryngoscopy under general anesthesia (LGA) is expected benefit the day before a transnasal endoscopy with white lamp (WL) and NBI by two different operators.
Suspected mucosal abnormalities showed by one or the two technics are reported in a table wich describes the different areas of the pharynx and the larynx.
During the LGA, several biopsies are performed and identified (WL and/or NBI).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of patients for whom superficial extension of the tumors has been increased by NBI.
Tidsramme: 4 minutes
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4 minutes
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of tumors upstaged.
Tidsramme: 4 minutes
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4 minutes
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Contribution of the NBI in the diagnosis of other synchronous locations.
Tidsramme: 4 minutes
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4 minutes
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Contribution of the NBI in the diagnosis of pre-neoplastic lesions.
Tidsramme: 4 minutes
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4 minutes
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Contribution of the NBI in the evaluation of surgical margins.
Tidsramme: 4 minutes
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4 minutes
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Sébastien VERGEZ, MD, PhD, University Hospital of Toulouse
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer, kjertel og epitel
- Neoplasmer i hode og nakke
- Otorhinolaryngologiske sykdommer
- Neoplasmer, plateepitelceller
- Karsinom
- Karsinom, plateepitel
- Plateepitelkarsinom i hode og nakke
- Laryngeale sykdommer
Andre studie-ID-numre
- 13 203 02
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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