Confocal Micro-endoscopy in Head and Neck Cancer/Micro Endoscopie Confocale (MEC)Oto-Rhino-Laryngologie (ORL)
Not Applicable
Completed
- Conditions
- Malignant Pharyngo Laryngeal TumorsPre-malignant Pharyngo Laryngeal Tumors
- Interventions
- Procedure: Confocal Micro Endoscopy
- Registration Number
- NCT01626638
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Brief Summary
The primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- Patients with malignant and pre-malignant pharyngo laryngeal tumors in whom direct laryngoscopy was performed under general anesthesia with biopsies for diagnostic or endoscopic removal
- > 18 years
- signed ICF
Exclusion Criteria
- Persons deprived of liberty
- Patients with history of allergy to patent blue
- Pregnant women or breastfeeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Confocal Micro Endoscopy -
- Primary Outcome Measures
Name Time Method Diagnostic correlation between confocal micro endoscopy and conventional histology at an average of 18 months
- Secondary Outcome Measures
Name Time Method Histological diagnostic with confocal micro endoscopy (MEC) VS conventional histological analysis At the time of the biopsy
Trial Locations
- Locations (2)
Institut Gustave Roussy
🇫🇷Villejuif, Val De Marne, France
Institut Universitaire Du Cancer de Toulouse - Oncopole
🇫🇷Toulouse, France