Clinical trial NCT02269020: Neck Dissection Via a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx
Official title: Unilateral Selective Neck Dissection at Lymph Node Levels IIa, III and IV Using a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx: the First Three Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Squamous Cell
Keywords: Squamous Cell Carcinoma of the Epi-larynx
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients that had pre-defined key points of the surgical procedure performed
timeFrame: Day 0
measure: Number of lymph nodes dissected
timeFrame: Day 0
Secondary outcomes:
measure: The duration of surgical site preparation
timeFrame: Day 0
measure: The duration of robot installation / preparation
timeFrame: Day O
measure: Intervention time (between incision and closure by the surgeon)
timeFrame: Day 0
measure: Time in general anesthesia
timeFrame: Day 0
measure: Surgical time (console time for robot-assisted surgery)
timeFrame: Day 0
measure: The estimated volume of bleeding
timeFrame: Day 0
measure: Need for conversion to open surgery
timeFrame: Day 0
measure: The anesthesia protocol used
timeFrame: Day 0
measure: The level of difficulty associated with each surgical step
timeFrame: Day 0
measure: The level of speed associated with each surgical step
timeFrame: Day 0
measure: Length of hospital stay in days
timeFrame: estimated max of 6 days
measure: Results of pathological analysis of lymph nodes
timeFrame: expected between day 7 and day 15
Other outcomes:
measure: The number of ganglions excised at each level.
timeFrame: expected between day 7 and day 15
measure: The number of metastatic ganglions
timeFrame: expected between day 7 and day 15
measure: The presence/absence of capsular rupture
timeFrame: expected between day 7 and day 15
measure: Normal functioning of cranial nerve IX: yes/no.
timeFrame: Day 15
measure: Normal functioning of cranial nerve X: yes/no.
timeFrame: Day 15
measure: Normal functioning of cranial nerve XI: yes/no.
timeFrame: Day 15
measure: Normal functioning of cranial nerve XII: yes/no.
timeFrame: Day 15
measure: Normal functioning of the brachial plexus nerve: yes/no.
timeFrame: Day 15
measure: Normal functioning of the cervical sympathetic nerve: yes/no.
timeFrame: Day 15
measure: Normal functioning of cranial nerve IX: yes/no.
timeFrame: Month 6
measure: Normal functioning of cranial nerve X: yes/no.
timeFrame: Month 6
measure: Normal functioning of cranial nerve XI: yes/no.
timeFrame: Month 6
measure: Normal functioning of cranial nerve XII: yes/no.
timeFrame: Month 6
measure: Normal functioning of the brachial plexus nerve: yes/no.
timeFrame: Month 6
measure: Normal functioning of the cervial sympathetic nerve: yes/no.
timeFrame: Month 6
measure: Normal functioning of cranial nerve IX: yes/no.
timeFrame: Month 12
measure: Normal functioning of cranial nerve X: yes/no.
timeFrame: Month 12
measure: Normal functioning of cranial nerve XI: yes/no.
timeFrame: Month 12
measure: Normal functioning of cranial nerve XII: yes/no.
timeFrame: Month 12
measure: Normal functioning of the brachial plexus nerve: yes/no.
timeFrame: Month 12
measure: Normal functioning of the cervical sympathetic nerve: yes/no.
timeFrame: Month 12
measure: Presence/absence of intraoperative complications
timeFrame: Day 0
measure: Presence / absence of complications during the hospitalization period
timeFrame: estimated max of 6 days
measure: Presence / absence of complications at the post-operative follow-up visit
timeFrame: day 7 to day 15
measure: Analgesic consumption
timeFrame: During hospitalization; expected max of 6 days
measure: Analgesic consumption
timeFrame: days 7 to 15
measure: Analgesic consumption
timeFrame: month 6
measure: Daily visual analog scale for pain
timeFrame: During hospitalization; expected max of 6 days.
measure: Visual analog scale for pain
timeFrame: days 7 to 15
measure: Visual analog scale for pain
timeFrame: month 6
measure: Visual analog scale for pain
timeFrame: month 12
measure: Length of axillary scar
timeFrame: day 0
measure: Length of thoracic scar
timeFrame: day 0
measure: Length of axillary scar
timeFrame: month 6
measure: Length of thoracic scar
timeFrame: month 6
measure: Length of axillary scar
timeFrame: month 12
measure: Length of thoracic scar
timeFrame: month 12
measure: Patient satisfaction concerning his/her scar
timeFrame: month 6
measure: Patient satisfaction concerning his/her scar
timeFrame: month 12
measure: Oncological results
timeFrame: month 6
measure: Oncological results
timeFrame: month 12
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Benjamin Lallemant, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: