Carcinoma, Squamous CellPhase 1RoboCurage ORLNCT02269020
Neck Dissection Via a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx
A Phase 1 study testing Neck Dissection in people with Carcinoma, Squamous Cell, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Carcinoma, Squamous Cell
- What is being tested?
- Neck Dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2015to 14 Sep 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Secondary objectives include the following:
- 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.
- Conditions
- Carcinoma, Squamous Cell
- Being tested
- Neck Dissection
- Keywords
- Squamous Cell Carcinoma of the Epi-larynx
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck DissectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 3 patients cancer of the epi larynx | Experimental | 3 patients with squamous cell carcinoma of the epi-larynx
Intervention: Neck Dissection Receives: Procedure: Neck Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Number of lymph nodes dissected
Determined by analysis of excised tissues.
Measured: Day 0
Secondary outcomes (12)
The duration of surgical site preparation
in minutes
Measured: Day 0
The duration of robot installation / preparation
in minutes
Measured: Day O
Intervention time (between incision and closure by the surgeon)
in minutes
Measured: Day 0
Time in general anesthesia
in minutes
Measured: Day 0
Surgical time (console time for robot-assisted surgery)
in minutes
Measured: Day 0
The estimated volume of bleeding
in ml
Measured: Day 0
Need for conversion to open surgery
yes/no
Measured: Day 0
The anesthesia protocol used
Full description.
Measured: Day 0
The level of difficulty associated with each surgical step
Qualitative: easy, medium, hard, extremely hard
Measured: Day 0
The level of speed associated with each surgical step
Qualitative: slow, normal, fast
Measured: Day 0
Length of hospital stay in days
Measured: estimated max of 6 days
Results of pathological analysis of lymph nodes
Measured: expected between day 7 and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study start16 Feb 2015
- Primary completion4 Sep 2017
- Study completion14 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Lallemant, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269020
- Sponsor's protocol ID
- LOCAL/2013/BL-01
- Other IDs
- 2014-A00117-40
- Acronym
- RoboCurage ORL
- Status last verified
- Jan 2019
- First submitted
- 8 Oct 2014
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02269020
- Acronym / sponsor ID
- RoboCurage ORL / LOCAL/2013/BL-01
- Conditions
- Carcinoma, Squamous Cell
- Keywords
- Squamous Cell Carcinoma of the Epi-larynx
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 16 Feb 2015 (actual)
- Primary completion
- 4 Sep 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 patients cancer of the epi larynx | Experimental | Procedure: Neck Dissection3 patients with squamous cell carcinoma of the epi-larynx Intervention: Neck Dissection |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck DissectionUnilateral 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. | Procedure or surgery | 3 patients cancer of the epi larynx |
Primary outcome
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.
Number of lymph nodes dissected
Time frame: Day 0
Determined by analysis of excised tissues.
12 secondary outcomes
The duration of surgical site preparation
Time frame: Day 0
The duration of robot installation / preparation
Time frame: Day O
Intervention time (between incision and closure by the surgeon)
Time frame: Day 0
Time in general anesthesia
Time frame: Day 0
Surgical time (console time for robot-assisted surgery)
Time frame: Day 0
The estimated volume of bleeding
Time frame: Day 0
Need for conversion to open surgery
Time frame: Day 0
The anesthesia protocol used
Time frame: Day 0
The level of difficulty associated with each surgical step
Time frame: Day 0
The level of speed associated with each surgical step
Time frame: Day 0
Length of hospital stay in days
Time frame: estimated max of 6 days
Results of pathological analysis of lymph nodes
Time frame: expected between day 7 and day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Lallemant, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neck Dissection in people with Carcinoma, Squamous Cell, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that had pre-defined key points of the surgical procedure performed (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.