- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Toulouse, Frankrike, 31059
- University of Toulouse
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Number of patients for whom superficial extension of the tumors has been increased by NBI.
Tidsram: 4 minutes
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4 minutes
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Number of tumors upstaged.
Tidsram: 4 minutes
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4 minutes
|
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Contribution of the NBI in the diagnosis of other synchronous locations.
Tidsram: 4 minutes
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4 minutes
|
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Contribution of the NBI in the diagnosis of pre-neoplastic lesions.
Tidsram: 4 minutes
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4 minutes
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Contribution of the NBI in the evaluation of surgical margins.
Tidsram: 4 minutes
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4 minutes
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sébastien VERGEZ, MD, PhD, University Hospital of Toulouse
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 13 203 02
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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