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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Francois Baclesse

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • bilateral mucosectomy + tonsillectomy

    Procedure/Surgery

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

  • tonsillectomy

    Procedure/Surgery

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

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Experimental ArmExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Detection of primary cancer

Proportion of patients with primary cancer detected with surgery

Time frame
At surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.