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

Launched by CENTRE FRANCOIS BACLESSE · Feb 22, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new surgical approach to help better understand and treat lymphadenopathy, which is the swelling of lymph nodes often related to cancer in the head and neck area. Researchers want to see if a procedure called bilateral basic tongue mucosectomy, done with the help of robot technology or laser, combined with tonsillectomy (removal of the tonsils), can provide better insights into the condition. This study is currently open for enrollment for adults aged 18 and older who have specific types of head and neck lymph node swelling and have undergone certain medical evaluations without finding a primary tumor.

To participate, individuals must meet some key criteria, including having a confirmed diagnosis of cancer spread to the lymph nodes, being in good enough health to undergo surgery, and being able to provide informed consent. Participants can expect to undergo the proposed surgical procedures, along with regular follow-up visits to monitor their recovery and gather more information about their condition. It’s important for potential participants to know that there are some exclusions, such as having a history of certain cancers or previous radiation treatment, which will be carefully reviewed by the study team.

Gender

ALL

Eligibility criteria

• 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