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Trial record 6 of 101 for:    Recruiting, Not yet recruiting, Available Studies | "Laryngeal Diseases"

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

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ClinicalTrials.gov Identifier: NCT02269020
Recruitment Status : Recruiting
First Posted : October 20, 2014
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.


Condition or disease Intervention/treatment Phase
Carcinoma, Squamous Cell Procedure: Neck Dissection Phase 1

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  (Clinical Trial)
Estimated Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2018

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.




Primary Outcome Measures :
  1. 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.

  2. Number of lymph nodes dissected [ Time Frame: Day 0 ]
    Determined by analysis of excised tissues.


Secondary Outcome Measures :
  1. The duration of surgical site preparation [ Time Frame: Day 0 ]
    in minutes

  2. The duration of robot installation / preparation [ Time Frame: Day O ]
    in minutes

  3. Intervention time (between incision and closure by the surgeon) [ Time Frame: Day 0 ]
    in minutes

  4. Time in general anesthesia [ Time Frame: Day 0 ]
    in minutes

  5. Surgical time (console time for robot-assisted surgery) [ Time Frame: Day 0 ]
    in minutes

  6. The estimated volume of bleeding [ Time Frame: Day 0 ]
    in ml

  7. Need for conversion to open surgery [ Time Frame: Day 0 ]
    yes/no

  8. The anesthesia protocol used [ Time Frame: Day 0 ]
    Full description.

  9. The level of difficulty associated with each surgical step [ Time Frame: Day 0 ]
    Qualitative: easy, medium, hard, extremely hard

  10. The level of speed associated with each surgical step [ Time Frame: Day 0 ]
    Qualitative: slow, normal, fast

  11. Length of hospital stay in days [ Time Frame: estimated max of 6 days ]
  12. Results of pathological analysis of lymph nodes [ Time Frame: expected between day 7 and day 15 ]

Other Outcome Measures:
  1. The number of ganglions excised at each level. [ Time Frame: expected between day 7 and day 15 ]
  2. The number of metastatic ganglions [ Time Frame: expected between day 7 and day 15 ]
  3. The presence/absence of capsular rupture [ Time Frame: expected between day 7 and day 15 ]
  4. Normal functioning of cranial nerve IX: yes/no. [ Time Frame: Day 15 ]
  5. Normal functioning of cranial nerve X: yes/no. [ Time Frame: Day 15 ]
  6. Normal functioning of cranial nerve XI: yes/no. [ Time Frame: Day 15 ]
  7. Normal functioning of cranial nerve XII: yes/no. [ Time Frame: Day 15 ]
  8. Normal functioning of the brachial plexus nerve: yes/no. [ Time Frame: Day 15 ]
  9. Normal functioning of the cervical sympathetic nerve: yes/no. [ Time Frame: Day 15 ]
  10. Normal functioning of cranial nerve IX: yes/no. [ Time Frame: Month 6 ]
  11. Normal functioning of cranial nerve X: yes/no. [ Time Frame: Month 6 ]
  12. Normal functioning of cranial nerve XI: yes/no. [ Time Frame: Month 6 ]
  13. Normal functioning of cranial nerve XII: yes/no. [ Time Frame: Month 6 ]
  14. Normal functioning of the brachial plexus nerve: yes/no. [ Time Frame: Month 6 ]
  15. Normal functioning of the cervial sympathetic nerve: yes/no. [ Time Frame: Month 6 ]
  16. Normal functioning of cranial nerve IX: yes/no. [ Time Frame: Month 12 ]
  17. Normal functioning of cranial nerve X: yes/no. [ Time Frame: Month 12 ]
  18. Normal functioning of cranial nerve XI: yes/no. [ Time Frame: Month 12 ]
  19. Normal functioning of cranial nerve XII: yes/no. [ Time Frame: Month 12 ]
  20. Normal functioning of the brachial plexus nerve: yes/no. [ Time Frame: Month 12 ]
  21. Normal functioning of the cervical sympathetic nerve: yes/no. [ Time Frame: Month 12 ]
  22. Presence/absence of intraoperative complications [ Time Frame: Day 0 ]
  23. Presence / absence of complications during the hospitalization period [ Time Frame: estimated max of 6 days ]
  24. Presence / absence of complications at the post-operative follow-up visit [ Time Frame: day 7 to day 15 ]
  25. Analgesic consumption [ Time Frame: During hospitalization; expected max of 6 days ]
    Qualitative: Level I, Level II, Level III.

  26. Analgesic consumption [ Time Frame: days 7 to 15 ]
    Qualitative: Level I, Level II, Level III.

  27. Analgesic consumption [ Time Frame: month 6 ]
    Qualitative: Level I, Level II, Level III.

  28. Daily visual analog scale for pain [ Time Frame: During hospitalization; expected max of 6 days. ]
  29. Visual analog scale for pain [ Time Frame: days 7 to 15 ]
  30. Visual analog scale for pain [ Time Frame: month 6 ]
  31. Visual analog scale for pain [ Time Frame: month 12 ]
  32. Length of axillary scar [ Time Frame: day 0 ]
  33. Length of thoracic scar [ Time Frame: day 0 ]
  34. Length of axillary scar [ Time Frame: month 6 ]
  35. Length of thoracic scar [ Time Frame: month 6 ]
  36. Length of axillary scar [ Time Frame: month 12 ]
  37. Length of thoracic scar [ Time Frame: month 12 ]
  38. Patient satisfaction concerning his/her scar [ Time Frame: month 6 ]
    visual analog scale from 0 to 10

  39. Patient satisfaction concerning his/her scar [ Time Frame: month 12 ]
    visual analog scale from 0 to 10

  40. 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.

  41. 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.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269020


Contacts
Contact: Benjamin Lallemant, MD, PhD +33.(0)4.66.68.36.85 benjamin.lallemant@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHRU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Benjiman Lallemant, MD, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Benjamin Lallemant, MD, PhD Centre Hospitalier Universitaire de Nîmes

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02269020     History of Changes
Other Study ID Numbers: LOCAL/2013/BL-01
2014-A00117-40 ( Other Identifier: RCB number )
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Squamous Cell Carcinoma of the Epi-larynx

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell