Confocal Micro-endoscopy in Head and Neck Cancer/Micro Endoscopie Confocale (MEC)Oto-Rhino-Laryngologie (ORL) (MEC ORL)

Gustave Roussy

Status: Completed

Conditions: Malignant Pharyngo Laryngeal Tumors; Pre-malignant Pharyngo Laryngeal Tumors

Treatments: Procedure: Confocal Micro Endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01626638

2011-A00818-33

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Experimental

Experimental group

Treatment:

Procedure: Confocal Micro Endoscopy