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

January 10, 2019 updated by: Centre Hospitalier Universitaire de Nīmes

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients that had pre-defined key points of the surgical procedure performed
Time Frame: Day 0
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
Time Frame: Day 0
Determined by analysis of excised tissues.
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The duration of surgical site preparation
Time Frame: Day 0
in minutes
Day 0
The duration of robot installation / preparation
Time Frame: Day O
in minutes
Day O
Intervention time (between incision and closure by the surgeon)
Time Frame: Day 0
in minutes
Day 0
Time in general anesthesia
Time Frame: Day 0
in minutes
Day 0
Surgical time (console time for robot-assisted surgery)
Time Frame: Day 0
in minutes
Day 0
The estimated volume of bleeding
Time Frame: Day 0
in ml
Day 0
Need for conversion to open surgery
Time Frame: Day 0
yes/no
Day 0
The anesthesia protocol used
Time Frame: Day 0
Full description.
Day 0
The level of difficulty associated with each surgical step
Time Frame: Day 0
Qualitative: easy, medium, hard, extremely hard
Day 0
The level of speed associated with each surgical step
Time Frame: Day 0
Qualitative: slow, normal, fast
Day 0
Length of hospital stay in days
Time Frame: estimated max of 6 days
estimated max of 6 days
Results of pathological analysis of lymph nodes
Time Frame: expected between day 7 and day 15
expected between day 7 and day 15

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of ganglions excised at each level.
Time Frame: expected between day 7 and day 15
expected between day 7 and day 15
The number of metastatic ganglions
Time Frame: expected between day 7 and day 15
expected between day 7 and day 15
The presence/absence of capsular rupture
Time Frame: expected between day 7 and day 15
expected between day 7 and day 15
Normal functioning of cranial nerve IX: yes/no.
Time Frame: Day 15
Day 15
Normal functioning of cranial nerve X: yes/no.
Time Frame: Day 15
Day 15
Normal functioning of cranial nerve XI: yes/no.
Time Frame: Day 15
Day 15
Normal functioning of cranial nerve XII: yes/no.
Time Frame: Day 15
Day 15
Normal functioning of the brachial plexus nerve: yes/no.
Time Frame: Day 15
Day 15
Normal functioning of the cervical sympathetic nerve: yes/no.
Time Frame: Day 15
Day 15
Normal functioning of cranial nerve IX: yes/no.
Time Frame: Month 6
Month 6
Normal functioning of cranial nerve X: yes/no.
Time Frame: Month 6
Month 6
Normal functioning of cranial nerve XI: yes/no.
Time Frame: Month 6
Month 6
Normal functioning of cranial nerve XII: yes/no.
Time Frame: Month 6
Month 6
Normal functioning of the brachial plexus nerve: yes/no.
Time Frame: Month 6
Month 6
Normal functioning of the cervial sympathetic nerve: yes/no.
Time Frame: Month 6
Month 6
Normal functioning of cranial nerve IX: yes/no.
Time Frame: Month 12
Month 12
Normal functioning of cranial nerve X: yes/no.
Time Frame: Month 12
Month 12
Normal functioning of cranial nerve XI: yes/no.
Time Frame: Month 12
Month 12
Normal functioning of cranial nerve XII: yes/no.
Time Frame: Month 12
Month 12
Normal functioning of the brachial plexus nerve: yes/no.
Time Frame: Month 12
Month 12
Normal functioning of the cervical sympathetic nerve: yes/no.
Time Frame: Month 12
Month 12
Presence/absence of intraoperative complications
Time Frame: Day 0
Day 0
Presence / absence of complications during the hospitalization period
Time Frame: estimated max of 6 days
estimated max of 6 days
Presence / absence of complications at the post-operative follow-up visit
Time Frame: day 7 to day 15
day 7 to day 15
Analgesic consumption
Time Frame: During hospitalization; expected max of 6 days
Qualitative: Level I, Level II, Level III.
During hospitalization; expected max of 6 days
Analgesic consumption
Time Frame: days 7 to 15
Qualitative: Level I, Level II, Level III.
days 7 to 15
Analgesic consumption
Time Frame: month 6
Qualitative: Level I, Level II, Level III.
month 6
Daily visual analog scale for pain
Time Frame: During hospitalization; expected max of 6 days.
During hospitalization; expected max of 6 days.
Visual analog scale for pain
Time Frame: days 7 to 15
days 7 to 15
Visual analog scale for pain
Time Frame: month 6
month 6
Visual analog scale for pain
Time Frame: month 12
month 12
Length of axillary scar
Time Frame: day 0
day 0
Length of thoracic scar
Time Frame: day 0
day 0
Length of axillary scar
Time Frame: month 6
month 6
Length of thoracic scar
Time Frame: month 6
month 6
Length of axillary scar
Time Frame: month 12
month 12
Length of thoracic scar
Time Frame: month 12
month 12
Patient satisfaction concerning his/her scar
Time Frame: month 6
visual analog scale from 0 to 10
month 6
Patient satisfaction concerning his/her scar
Time Frame: month 12
visual analog scale from 0 to 10
month 12
Oncological results
Time Frame: month 6
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
Time Frame: month 12
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Benjamin Lallemant, MD, PhD, Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 4, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOCAL/2013/BL-01
  • 2014-A00117-40 (Other Identifier: RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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