Pilot Study of Single Port Robotic Surgery for Anatomical Lung Resection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Incidence of conversion rate
研究概览
简要总结
This is the first human clinical study for explore the feasibility of lung anatomic resection through Da Vinci SP surgical platform
详细描述
During the past several years, minimally invasive thoracic surgery has evolved from thoracoscopic approaches using 3 -4 ports to a single incision video-assisted thoracoscopic surgery (VATS) techniques. Recently, the experience acquired with the uniportal VATS technique through the intercostal space has allowed the development of a uniportal VATS subxiphoid or subcostal approach for major pulmonary resections. The advantage of using a subxiphoid or subcostal entry is to reduce pain by avoiding possible trauma of intercostal nerves caused by thoracic incisions. However, the longer distance from the subxiphoid or subcostal incision to the hilum makes this approach more difficult to perform anatomical pulmonary resections.During this same period of evolution into uniportal VATS surgery, robotic thoracic surgery has gained popularity as an alternative to traditional VATS. The advantages of robotics are the ability to perform surgery more precisely with articulated or wristed instruments, motion scaling, and tremor filtration, as well as improved visualization thanks to 3D high-definition video. However, currently 4 -5 incisions are still necessary to perform anatomic robotic resections.Recently, there has been a convergence of these two trends-uniportal surgery and robotic-assisted surgery-and has resulted in a single port robotic system, the da Vinci SP by Intuitive Surgical Cooperation. For this new platform, investigators plan to practice in thoracic anatomic lung resection
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >20 and <75 years-old
- •Willing and able to provide informed consent
- •The subject is undergoing the following procedures
- •diagnosis with of clinical stage I lung cancer
- •The primary tumor should be less than ≤4cm diameter and ≥ 2 cm away from the origin of the associated lobar bronchus
- •Preoperative platelet count 150-400 (1000/ uL)
排除标准
- •Congestive heart failure (NHYA > II)
- •Subjects with a known bleeding or clotting disorder
- •Subjects actively receiving therapeutic dose anticoagulation or anti-platelet medications at the time of operation
- •Subjects under immunomodulatory or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgery
- •Subjects with pulmonary hypertension
- •In need of extended resection (e.g. Chest wall, Carina, major vessel, bilobectomy) and reconstruction (e.g. Sleeve resection, bronchoplasty, angioplasty)
- •Previous ipsilateral thoracic surgery or sternotomy
- •Uncontrolled illness 6 months prior to planned surgical procedure including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Previous neoadjuvant medical and/or radiation therapy
- •Subject has a contraindication for general anesthesia or surgery
- •Life expectancy < 6 months
- •Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
- •Subjects belong to vulnerable population (e.g., pregnancy or breastfeeding)
- •International normalized ratio, INR >1.4
- •Activated Partial Thromboplastin Time , APTT >35 -
结局指标
主要结局
Incidence of conversion rate
时间窗: During Surgery
The primary performance endpoint will be assessed as the ability to successfully complete the planned anatomic resection procedure with the da Vinci SP System, with no conversion to thoracoscopic, multi-port robotic, or open surgery. Usage of additional assistant port(s) is not considered a conversion.
次要结局
- Patient disposition immediately after surgery(During Hospitalization, an average of 1 day)
- Peri-operative parameters: blood loss related(During surgery)
- Incidence of Treatment Related Adverse Events(One Year)
- Peri-operative parameters(From Surgery to ward,2- day)
- Hospitalization parameters(During Hospitalization, an average of 4 days)
- Operative related complications during hospitalization(During Hospitalization, an average of 4 days)