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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2029-03-31

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

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Detailed Description

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Conditions

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Cancer of Head and Neck Adenopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

tonsillectomy +/- bilateral mucosectomy

Study Groups

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Experimental Arm

Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)

Group Type EXPERIMENTAL

bilateral mucosectomy + tonsillectomy

Intervention Type PROCEDURE

Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)

Control Arm

Tonsillectomy alone (unilateral or bilateral at the choice of the investigator)

Group Type ACTIVE_COMPARATOR

tonsillectomy

Intervention Type PROCEDURE

tonsillectomy (unilateral or bilateral at the choice of the investigator)

Interventions

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bilateral mucosectomy + tonsillectomy

Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)

Intervention Type PROCEDURE

tonsillectomy

tonsillectomy (unilateral or bilateral at the choice of the investigator)

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No