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

NCT02269020 | Completed Phase 1 DMC

• 2 other identifiers: LOCAL/2013/BL-012014-A00117-40
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Squamous Cell

Keywords

Squamous Cell Carcinoma of the Epi-larynx

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 0

• Number of lymph nodes dissected

  Determined by analysis of excised tissues.

  Day 0

Secondary Outcomes (12)

• The duration of surgical site preparation

  Day 0

• The duration of robot installation / preparation

  Day O

• Intervention time (between incision and closure by the surgeon)

  Day 0

• Time in general anesthesia

  Day 0

• Surgical time (console time for robot-assisted surgery)

  Day 0

Other Outcomes (41)

• The number of ganglions excised at each level.

  expected between day 7 and day 15

• The number of metastatic ganglions

  expected between day 7 and day 15

• The presence/absence of capsular rupture

  expected between day 7 and day 15

Study Arms (1)

3 patients cancer of the epi larynx

EXPERIMENTAL

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

Procedure: Neck Dissection

Interventions

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.

3 patients cancer of the epi larynx

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Neck Dissection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lymph Node Excision; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Officials

• Benjamin Lallemant, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 20, 2014
• Study Start: February 16, 2015
• Primary Completion: September 4, 2017
• Study Completion: September 14, 2017
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

FR (1)