Status:
COMPLETED
Neck Dissection Via a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Carcinoma, Squamous Cell
Eligibility:
All Genders
18-89 years
Phase:
PHASE1
Brief Summary
The main hypothesis of this study is that it is possible to make a unilateral selective dissection of ganglion levels IIa, III and IV using an endoscopic transaxillary approach via the da Vinci roboti...
Detailed Description
Secondary objectives include the following: A. Describe certain technical variables: surgical time, extent of blood loss, need for conversion to open surgery, anesthesia procedure used, the level of ...
Eligibility Criteria
Inclusion
- Cancer of the epi-larynx: (i) ranked T1 or T2 in the TNM classification, (ii) supraglottic or glotto-supraglottic location, (iii) CN0 nodal status
- Absence of distant metastasis (M0)
- Decision for unilateral endoscopic axillary neck dissection at lymph node levels IIa, III and IV of the Robins classification is retained in a multidisciplinary meeting
- The patient is available for 12 months of follow-up
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
Exclusion
- Patient participating in or having participated in another study within the previous 3 months or currently in an exclusion period determined by a previous study
- Adult under judicial protection or any kind of guardianship
- Refusal to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
- Preoperative diagnosis of a second location of cancerous disease
- Body Mass Index \> 25
- History of cervical spine surgery
- History of instability of the cervical spine
- History of surgery in the shoulder or pre-pectoral region
- History of ipsilateral neck surgery
- History of cervical radiotherapy
- History of breast implants
Key Trial Info
Start Date :
February 16 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2017
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02269020
Start Date
February 16 2015
End Date
September 14 2017
Last Update
January 11 2019
Active Locations (1)
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1
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France, 30029