The Role of Robotic Surgery in Pulmonary Metastasectomy: a Retrospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,650
- 试验地点
- 3
- 主要终点
- PERIOPERATIVE OUTCOME
研究概览
简要总结
The study is observational, multicenter retrospective and will involve multiple research centers. The aim is to outline the indications for surgical management with robot-assisted pulmonary metastasectomy through a confrontation of robot-assisted thoracoscopic surgery (RATS) with video-assisted thoracoscopic surgery (VATS) and thoracotomy. The study will focus on pulmonary metastasectomies from any primary solid tumor (with the exception of lung cancer). There are no risks for the patients, as this is a retrospective data collection.
详细描述
The investigators will identify selection criteria according to ASA score (American Society of Anaesthesiologists physical status classification system ) and co-morbidities, respiratory function, control and staging of the primary pathology, number and position of metastases. The investigators will assess the robotic approach performance in the different anatomical resections (lobectomies, bilobectomies, segmentectomies,pneumectomies) considering potential intra- and post-operative complications, over than rates of positive margins.
It analyses cases of pulmonary metastasectomy performed with a minimally invasive approach such as robot-assisted thoracoscopic surgery (RATS) and video-assisted thoracoscopic surgery (VATS), or with a traditional open approach. More precisely, it will compare RATS vs VATS as well as RATS vs open.
It was decided to exclude simple wedge resections since, in light of the minimal resection of parenchyma and the costs sustained for the equipment, they are preferably carried out by VATS.
Criteria for the inclusion of patients:
- The patient can be candidate in terms of ASA score, cardiac, kidney, liver and respiratory function
- The primary pathology is under control or controllable
- Absence of extrapulmonary metastases that are not controlled or controllable
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •The patient can be candidate in terms of ASA score, cardiac, kidney, liver and respiratory function
- •The primary pathology is under control or controllable
- •Absence of extrapulmonary metastases that are not controlled or controllable
排除标准
- •Age >/= ; then 18 years at the moment of surgery
- •Patients who cannot undergo surgery, as they do not meet the conditions outlined above.
结局指标
主要结局
PERIOPERATIVE OUTCOME
时间窗: from hospitalization to the discharge date at maximum one week
The primary objective consists in the definition of indication of the robotic approach in pulmonary metastasectomy. The investigators will measure the potential technical superiority of Robotic Assisted Thoracoscopic Surgery (RATS), as compared to Video Assisted Thoracic Surgery (VATS) and thoracotomy, in the different types of anatomical resection for lung metastasectomy, by analizing intra- and post-operative complications, which will be categorized according to Clavien-Dindo scale.
PERIOPERATIVE OUTCOME 2
时间窗: from surgery to time of pathological response
The primary objective consists in the definition of indication of the robotic approach in pulmonary metastasectomy. The investigators will measure the potential technical superiority of Robotic Assisted Thoracoscopic Surgery (RATS), as compared to Video Assisted Thoracic Surgery (VATS) and thoracotomy, in the different types of anatomical resection for lung metastasectomy, by analizing the rate of resection radicality.
次要结局
- PATHOLOGICAL OUTCOME 3(from surgery to time of pathological response)
- PATHOLOGICAL OUTCOME 4(from surgery to time of pathological response)
- PATHOLOGICAL OUTCOME(from surgery to time of pathological response)
- PATHOLOGICAL OUTCOME 2(from surgery to time of pathological response)
研究者
Stefano Viscardi
MD
Scientific Institute San Raffaele