RecruitingPhase 2NCT04767048

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

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


Sponsor

Centre Francois Baclesse

Enrollment

72 participants

Start Date

Jun 30, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether robotic-assisted or laser-assisted tongue base surgery combined with tonsil removal can help find a hidden primary cancer in patients who have suspicious swollen lymph nodes in the neck but whose cancer source has not yet been identified. **You may be eligible if...** - You have enlarged neck lymph nodes that are suspicious for cancer (head and neck squamous cell carcinoma metastasis) - Prior tests, including PET scan, CT scan, and nasal scope exam, have not found the primary cancer source - You are 18 years or older - You are affiliated with the social security system (for French participants) **You may NOT be eligible if...** - You have a prior history of squamous cell cancer in the head/neck area - Your performance status is 2 or higher (meaning you are not fully active) - You did not sign informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREbilateral mucosectomy + tonsillectomy

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

PROCEDUREtonsillectomy

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


Locations(5)

Centre François Baclesse

Caen, France

CHU CAEN

Caen, France

Centre Oscar Lambret

Lille, France

Chru Lille

Lille, France

CHU Rouen

Rouen, France

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NCT04767048


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