Prospective Study Assessing Thyroidectomy Using Robot
试验速览
- 阶段
- 2 期
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Efficacy for malignant tumor
研究概览
简要总结
The robot-assisted surgery for benign and malignant thyroid tumors was widely developed in Asia and begins to spread in Western countries. The main advantage of the technique is to avoid a scar in the neck by placing it either in the axilla or at the hairline behind the ear to improve esthetic consequences and body image. It is not surgery minimally invasive but rather a way of remote access surgery.
Data from the literature including cohort studies and meta-analyzes attest the security of the procedure in comparison with classic thyroid surgery (which remains the "gold standard"). However there is few data on the effectiveness of the technique in terms of the completeness of the surgery, according to the routine standard criteria used in endocrinology and endocrine cancer, and no French medico-economic study has been performed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Benign thyroid nodule or follicular or suspicious cytological (Bethesda classifications 2, 3, 4, or 5) requiring thyroid lobectomy or total thyroidectomy therapeutic or diagnostic
- •Differentiated thyroid cancers - CN0 (no suspicious lymph node in the central or lateral compartments on preoperative ultrasound - CN1A / b with lymph node metastases <or = 10 mm in areas VI, III and / or IV, detected on preoperative ultrasound - For which the indication of a lobectomy or total thyroidectomy, with or without dissection of the central compartment and / or lateral neck was put in multidisciplinary meeting
- •Patient with no cons-indication to thyroid surgery or without dissection
- •Patient general condition of WHO grade 0-1
- •Patient age > 18 years and able to comply with the protocol visits
- •Patient agreeing to undergo robot-assisted surgery, the incision being at patient choice, depending on the wishes concerning the location of the scar (Axillary or behind the ear channel)
- •Patient Information or his legal representative and signed consent enlightened
- •Patient affiliated to a system of social security or beneficiary of such a scheme
排除标准
- •A history of cervical surgery or external beam radiation therapy
- •Anomaly craniocervical hinge or symptomatic cervical spondylosis
- •Congenital or acquired shoulder or ipsilateral upper limb surgery (for axillary )
- •paralysis preoperatively ( a laryngoscopic examination will be performed systematically preoperatively )
- •tumors with obvious extra- thyroid extension or suspected during preoperative ( cT3T4 )
- •metastatic cervical lymphadenopathy > 10 mm during the preoperative
- •Pregnant women or during lactation
- •patient already included in another clinical trial with a molecule experimental
研究组 & 干预措施
Da Vinci Xi
干预措施: Da Vinci Xi (Device)
结局指标
主要结局
Efficacy for malignant tumor
时间窗: Assessed 12 months after surgery
Rate of patients in complete remission at 12 months, remission defined as no biological or radiological anomaly: * Tg / LT4 \< 2 ng / ml in the absence of treatment with 131I ( in the absence of anti Tg antibodies) or Tg / LT4 \<0.2 ng / mL in patients treated with 131I (absent anti Tg antibody ) * Normal cervical ultrasound * Normal SPECT -CT if treatment with 131I * If realized : CT and / or normal 18 FDG - PET
Efficacy for benign tumor
时间窗: Assessed 3 months after surgery
If total thyroidectomy : rate of patients with thyroglobulin (Tg) under non- suppressive treatment with L-thyroxine ( LT4 ) \<2 ng / ml to 3 months with a target value TSH between 0.5 and 2 ng / mL If lobectomy : size of the remaining thyroid ipsilateral to the surgery evaluated sonographically \<11 mm ( larger diameter ) to 3 months
次要结局
未报告次要终点