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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04767048

Acronym

RoboCUP

Enrollment

Registered

2021-02-23

Start date

2021-06-30

Completion date

2029-03-31

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenopathy, Cancer of Head and Neck

Keywords

mucosectomy, tonsil

Brief 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

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Masking description

tonsillectomy +/- bilateral mucosectomy

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Detection of primary cancer	At surgery	Proportion of patients with primary cancer detected with surgery

Countries

France

Contacts

Primary ContactVianney BASTIT, MD

v.bastit@baclesse.unicancer.fr33231455050

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026