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NCT Number: NCT02269020

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

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.

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Key information

Conditions

Carcinoma, Squamous Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neck dissection

Procedure

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: RoboCurage ORL

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2014
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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