About this trial
We are proposing a randomized phase II study to assess the benefit of bilateral robot-assisted or laser basal tongue mucosectomy in combination with tonsillectomy in the assessment of prevalent cervical lymphadenopathy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with a prevalent head and neck lymphadenopathy with positive or non-contributory fine needle aspiration, or having had an adenectomy revealing a metastasis of squamous cell carcinoma, a PET examination, an injected cervico-thoracic CT and an ENT work-up (nasofibroscopy) not finding a primary tumor
Performance Status < 2
Patient aged 18 or over
Patient affiliated with social security system
Disqualifiers
History of squamous cell carcinoma of the VADS or skin of the face.
History of cervico-facial radiotherapy
Primary tumor discovering during pan-endoscopy
Inexposable patient lead not to possible mucosectomy
Trial design
Parallel
Treatments tested in this trial
bilateral mucosectomy + tonsillectomy
Procedure/SurgeryBasic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)
tonsillectomy
Procedure/Surgerytonsillectomy (unilateral or bilateral at the choice of the investigator)
Treatment groups
Trial outcomes
Primary outcomes
Detection of primary cancer
Proportion of patients with primary cancer detected with surgery
Sponsors and contacts
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