Neck Dissection Via a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx (RoboCurage ORL)

Centre Hospitalier Universitaire de Nīmes

Status and phase

Completed

Phase 1

Conditions

Carcinoma, Squamous Cell

Treatments

Procedure: Neck Dissection

Study type

Interventional

Funder types

Other

Identifiers

NCT02269020

2014-A00117-40 (Other Identifier)

LOCAL/2013/BL-01

Details and patient eligibility

About

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 robotic system to reduce scarring, while respecting patient safety.

Feasibility will be assessed by two combinded criteria: 1) performance of the surgical procedure respecting the different stages of visualization and dissection of key anatomical elements; 2) obtain a minimum of 9 lymph nodes when analyzing pathological evidence of the dissection.

Full 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 difficulty and speed associated with each surgical step, length of stay, B. Describe the pathological findings for each patient, C. Evaluate neurological complications (function of cranial nerve pairs X, XI, XII, brachial plexus, cervical sympathetic) D. Identify specific complications, E. Evaluate post-operative pain, F. Evaluate the scar outcome at 6 and 12 months G. Describe the oncological results at 6 and 12 months.

Enrollment

3 patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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