An International Multicenter Retrospective Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach
研究概览
简要总结
The study is a retrospective observational study. The study is designed to be multicentric and international and it will analyze medical records from selected patients diagnosed with locally advanced and resectable NSCLC who underwent lung resection by robotic, VATS and open approach after receiving neoadjuvant chemo-immunotherapy.
There are no risks for the patients, as this is a retrospective data collection.
详细描述
The use of neoadjuvant chemo-immunotherapy for the treatment of non-small cell lung cancer (NSCLC) is increasing. However, there is limited research comparing the feasibility and oncologic efficacy of robot-assisted thoracoscopic surgery (RATS), video-assisted thoracoscopic surgery (VATS), and open lung resection, in patients already treated with neoadjuvant chemo-immunotherapy. This study aims to evaluate the benefits of RATS compared to VATS and open surgery in terms of short-term outcomes for patients with NSCLC undergoing neoadjuvant chemo-immunotherapy.
All adult patients diagnosed with locally advanced and resectable NSCLC who underwent lung resection from 01-01-2016 to 31-03-2024 by robotic, VATS and open approach after receiving neoadjuvant chemo-immunotherapy will be included.
Patients are divided into three groups: robotic lung resection; video-assisted thoracoscopic (VATS) lung resection; open lung resection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Diagnosis of clinical or pathological stage IIB (T1-2, hilar N1, M0) and III (any T, N1-2, M0) NSCLC surgically treated with robotic, VATS and open approach with radical intent from 1st of January 2016 to 31st of March 2024
- •Received neoadjuvant chemo-immunotherapy or immunotherapy alone
- •Age >= 18 years old at the moment of surgery
排除标准
- •Age <18 years old at the moment of surgery
结局指标
主要结局
The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach
时间窗: 30-90 days after surgery
The investigators will measure the perioperative complications of VATS approach in patients who received neoadjuvant chemo-immunotherapy. Complications will be categorized according to the Clavien-Dindo scale.
The perioperative complications of robotic approach
时间窗: from the surgery at 30-90 days after
The investigators will measure the perioperative complications of robotic lung resection in patients who received neoadjuvant chemo-immunotherapy. Complications will be categorized according to the Clavien-Dindo scale.
The perioperative complications of the open approach
时间窗: 30-90 days after surgery
The investigators will measure the perioperative complications of open approach in patients who received neoadjuvant chemo-immunotherapy. Complications will be categorized according to the Clavien-Dindo scale.
次要结局
- Duration of surgery(from 30 days after surgery)
- Quality of lymphadenectomy(from 30 days after surgery)
- Conversion rate(from 30 days after surgery)
- Radicality of the resection(from 30 days after surgery)
- Oncological treatment(from 30 days after surgery)
- Survival analysis(from 3 to 5 years after surgery)
研究者
Pierluigi Novellis
Principal Investigator
Scientific Institute San Raffaele