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

Carcinoma, Squamous Cell Clinical Trial

— RoboCurage ORL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269020
• Other study ID #: LOCAL/2013/BL-01
• Secondary ID: 2014-A00117-40
• Status: Completed
• Phase: Phase 1
• Start date: February 16, 2015
• Est. completion date: September 14, 2017

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: September 14, 2017
• Est. primary completion date: September 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The number of ganglions excised at each level.		expected between day 7 and day 15
Other	The number of metastatic ganglions		expected between day 7 and day 15
Other	The presence/absence of capsular rupture		expected between day 7 and day 15
Other	Normal functioning of cranial nerve IX: yes/no.		Day 15
Other	Normal functioning of cranial nerve X: yes/no.		Day 15
Other	Normal functioning of cranial nerve XI: yes/no.		Day 15
Other	Normal functioning of cranial nerve XII: yes/no.		Day 15
Other	Normal functioning of the brachial plexus nerve: yes/no.		Day 15
Other	Normal functioning of the cervical sympathetic nerve: yes/no.		Day 15
Other	Normal functioning of cranial nerve IX: yes/no.		Month 6
Other	Normal functioning of cranial nerve X: yes/no.		Month 6
Other	Normal functioning of cranial nerve XI: yes/no.		Month 6
Other	Normal functioning of cranial nerve XII: yes/no.		Month 6
Other	Normal functioning of the brachial plexus nerve: yes/no.		Month 6
Other	Normal functioning of the cervial sympathetic nerve: yes/no.		Month 6
Other	Normal functioning of cranial nerve IX: yes/no.		Month 12
Other	Normal functioning of cranial nerve X: yes/no.		Month 12
Other	Normal functioning of cranial nerve XI: yes/no.		Month 12
Other	Normal functioning of cranial nerve XII: yes/no.		Month 12
Other	Normal functioning of the brachial plexus nerve: yes/no.		Month 12
Other	Normal functioning of the cervical sympathetic nerve: yes/no.		Month 12
Other	Presence/absence of intraoperative complications		Day 0
Other	Presence / absence of complications during the hospitalization period		estimated max of 6 days
Other	Presence / absence of complications at the post-operative follow-up visit		day 7 to day 15
Other	Analgesic consumption	Qualitative: Level I, Level II, Level III.	During hospitalization; expected max of 6 days
Other	Analgesic consumption	Qualitative: Level I, Level II, Level III.	days 7 to 15
Other	Analgesic consumption	Qualitative: Level I, Level II, Level III.	month 6
Other	Daily visual analog scale for pain		During hospitalization; expected max of 6 days.
Other	Visual analog scale for pain		days 7 to 15
Other	Visual analog scale for pain		month 6
Other	Visual analog scale for pain		month 12
Other	Length of axillary scar		day 0
Other	Length of thoracic scar		day 0
Other	Length of axillary scar		month 6
Other	Length of thoracic scar		month 6
Other	Length of axillary scar		month 12
Other	Length of thoracic scar		month 12
Other	Patient satisfaction concerning his/her scar	visual analog scale from 0 to 10	month 6
Other	Patient satisfaction concerning his/her scar	visual analog scale from 0 to 10	month 12
Other	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
Other	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
Primary	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
Primary	Number of lymph nodes dissected	Determined by analysis of excised tissues.	Day 0
Secondary	The duration of surgical site preparation	in minutes	Day 0
Secondary	The duration of robot installation / preparation	in minutes	Day O
Secondary	Intervention time (between incision and closure by the surgeon)	in minutes	Day 0
Secondary	Time in general anesthesia	in minutes	Day 0
Secondary	Surgical time (console time for robot-assisted surgery)	in minutes	Day 0
Secondary	The estimated volume of bleeding	in ml	Day 0
Secondary	Need for conversion to open surgery	yes/no	Day 0
Secondary	The anesthesia protocol used	Full description.	Day 0
Secondary	The level of difficulty associated with each surgical step	Qualitative: easy, medium, hard, extremely hard	Day 0
Secondary	The level of speed associated with each surgical step	Qualitative: slow, normal, fast	Day 0
Secondary	Length of hospital stay in days		estimated max of 6 days
Secondary	Results of pathological analysis of lymph nodes		expected between day 7 and day 15