Clinical trial · Interventional
Neck Dissection Via a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neck Dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 3 patients cancer of the epi larynx
- description
- 3 patients with squamous cell carcinoma of the epi-larynx Intervention: Neck Dissection
- interventionNames
- Procedure: Neck Dissection
Primary outcomes (2)
- measure
- Number of patients that had pre-defined key points of the surgical procedure performed
- timeFrame
- Day 0
- description
- 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.
- measure
- Number of lymph nodes dissected
- timeFrame
- Day 0
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
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
References
Publications (0)
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