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

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

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Squamous Cell
• Intervention / Treatment: Procedure: Neck 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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 patients cancer of the epi larynx; 3 patients with squamous cell carcinoma of the epi-larynx Intervention: Neck Dissection	Procedure: Neck Dissection; Unilateral Selective Neck Dissection at Lymph Node Levels IIa, III and IV Using a Robot-assisted Transaxillary Approach. The robotic system used is the da Vinci system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients that had pre-defined key points of the surgical procedure performed	Were all pre-defined key points of the surgical procedure performed? yes/no Description of the key points (includes (i) axillary approach, (ii) robot arm insertion, (iii) dissection, (iv) closing) of the surgical procedure.	Day 0
Number of lymph nodes dissected	Determined by analysis of excised tissues.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of surgical site preparation	in minutes	Day 0
The duration of robot installation / preparation	in minutes	Day O
Intervention time (between incision and closure by the surgeon)	in minutes	Day 0
Time in general anesthesia	in minutes	Day 0
Surgical time (console time for robot-assisted surgery)	in minutes	Day 0
The estimated volume of bleeding	in ml	Day 0
Need for conversion to open surgery	yes/no	Day 0
The anesthesia protocol used	Full description.	Day 0
The level of difficulty associated with each surgical step	Qualitative: easy, medium, hard, extremely hard	Day 0
The level of speed associated with each surgical step	Qualitative: slow, normal, fast	Day 0
Length of hospital stay in days		estimated max of 6 days
Results of pathological analysis of lymph nodes		expected between day 7 and day 15

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of ganglions excised at each level.		expected between day 7 and day 15
The number of metastatic ganglions		expected between day 7 and day 15
The presence/absence of capsular rupture		expected between day 7 and day 15
Normal functioning of cranial nerve IX: yes/no.		Day 15
Normal functioning of cranial nerve X: yes/no.		Day 15
Normal functioning of cranial nerve XI: yes/no.		Day 15
Normal functioning of cranial nerve XII: yes/no.		Day 15
Normal functioning of the brachial plexus nerve: yes/no.		Day 15
Normal functioning of the cervical sympathetic nerve: yes/no.		Day 15
Normal functioning of cranial nerve IX: yes/no.		Month 6
Normal functioning of cranial nerve X: yes/no.		Month 6
Normal functioning of cranial nerve XI: yes/no.		Month 6
Normal functioning of cranial nerve XII: yes/no.		Month 6
Normal functioning of the brachial plexus nerve: yes/no.		Month 6
Normal functioning of the cervial sympathetic nerve: yes/no.		Month 6
Normal functioning of cranial nerve IX: yes/no.		Month 12
Normal functioning of cranial nerve X: yes/no.		Month 12
Normal functioning of cranial nerve XI: yes/no.		Month 12
Normal functioning of cranial nerve XII: yes/no.		Month 12
Normal functioning of the brachial plexus nerve: yes/no.		Month 12
Normal functioning of the cervical sympathetic nerve: yes/no.		Month 12
Presence/absence of intraoperative complications		Day 0
Presence / absence of complications during the hospitalization period		estimated max of 6 days
Presence / absence of complications at the post-operative follow-up visit		day 7 to day 15
Analgesic consumption	Qualitative: Level I, Level II, Level III.	During hospitalization; expected max of 6 days
Analgesic consumption	Qualitative: Level I, Level II, Level III.	days 7 to 15
Analgesic consumption	Qualitative: Level I, Level II, Level III.	month 6
Daily visual analog scale for pain		During hospitalization; expected max of 6 days.
Visual analog scale for pain		days 7 to 15
Visual analog scale for pain		month 6
Visual analog scale for pain		month 12
Length of axillary scar		day 0
Length of thoracic scar		day 0
Length of axillary scar		month 6
Length of thoracic scar		month 6
Length of axillary scar		month 12
Length of thoracic scar		month 12
Patient satisfaction concerning his/her scar	visual analog scale from 0 to 10	month 6
Patient satisfaction concerning his/her scar	visual analog scale from 0 to 10	month 12
Oncological results	Qualitative variable: (A) Living with disease progression, if so: (i) Recurrence: yes / no; (ii) Metastases: yes / no. or (B) Living without recurrence or (C) Deceased; give causes.	month 6
Oncological results	Qualitative variable: (A) Living with disease progression, if so: (i) Recurrence: yes / no; (ii) Metastases: yes / no. or (B) Living without recurrence or (C) Deceased; give causes.	month 12

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Benjamin Lallemant, MD, PhD, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2015
• Primary Completion (Actual): September 4, 2017
• Study Completion (Actual): September 14, 2017

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: October 17, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Actual): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Squamous Cell Carcinoma of the Epi-larynx
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: LOCAL/2013/BL-01; 2014-A00117-40 (Other Identifier: RCB number)