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

Primary Purpose

Carcinoma, Squamous Cell

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Neck Dissection
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Squamous Cell focused on measuring Squamous Cell Carcinoma of the Epi-larynx

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3 patients cancer of the epi larynx

Arm Description

3 patients with squamous cell carcinoma of the epi-larynx Intervention: Neck Dissection

Outcomes

Primary Outcome Measures

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.
Number of lymph nodes dissected
Determined by analysis of excised tissues.

Secondary Outcome Measures

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

Full Information

First Posted
October 8, 2014
Last Updated
January 10, 2019
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02269020
Brief Title
Neck Dissection Via a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 16, 2015 (Actual)
Primary Completion Date
September 4, 2017 (Actual)
Study Completion Date
September 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell
Keywords
Squamous Cell Carcinoma of the Epi-larynx

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Lallemant, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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

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