Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination With Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy

Study Overview
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Brief Summary
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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

Official Title
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Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination With Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy: a Randomized Phase II Study

Conditions
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Adenopathy, Cancer of Head and Neck

Intervention / Treatment
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* Procedure: bilateral mucosectomy + tonsillectomy
* Procedure: tonsillectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Informed consent signed Exclusion Criteria: 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 Uncontrollable hemostasis disorders (contraindication to tonsillectomy and basic bilateral mucosectomy of language) Distant metastases Lymphadenopathy inoperable Patient with a contraindication to radiotherapy Pregnant or breastfeeding woman Women of childbearing potential without effective contraception Patient under guardianship or unable to give informed consent Patient unable to undergo the trial follow-up for geographic, social or psychopathological reasons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator) | Procedure: bilateral mucosectomy + tonsillectomy<br>* Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)<br>|
| Active Comparator: Control Arm<br>Tonsillectomy alone (unilateral or bilateral at the choice of the investigator) | Procedure: tonsillectomy<br>* tonsillectomy (unilateral or bilateral at the choice of the investigator)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of primary cancer | Proportion of patients with primary cancer detected with surgery | At surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mucosectomy, tonsil