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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of patients that had pre-defined key points of the surgical procedure performed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
3 patients cancer of the epi larynx
3 patients with squamous cell carcinoma of the epi-larynx
Intervention: Neck Dissection
干预措施: Neck Dissection (Procedure)
结局指标
主要结局
Number of patients that had pre-defined key points of the surgical procedure performed
时间窗: 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
时间窗: Day 0
Determined by analysis of excised tissues.
次要结局
- 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)
- The level of difficulty associated with each surgical step(Day 0)
- Results of pathological analysis of lymph nodes(expected between day 7 and day 15)
- The duration of surgical site preparation(Day 0)
- Surgical time (console time for robot-assisted surgery)(Day 0)
- Need for conversion to open surgery(Day 0)
- Length of hospital stay in days(estimated max of 6 days)
- The estimated volume of bleeding(Day 0)
- The anesthesia protocol used(Day 0)
- The level of speed associated with each surgical step(Day 0)