Sleeve Lobectomy for Lung Cancer in Minimally Invasive Surgical Techniques: a Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 4
- 主要终点
- 3-year RFS
研究概览
简要总结
The goal of this multicenter observational study is to evaluate the long-term survival and perioperative outcomes of sleeve lobectomy in robotic-assisted thoracic surgery (RATS) for patients with central lung cancer when compared with video-assisted thoracic surgery (VATS) approach, both of which have been already applied to these patients in minimally invasive surgical techniques as part of their regular medical care recently. The main question it aims to answer is:
Are RATS sleeve lobectomy associated with similar or even better long-term survival and perioperative outcomes for patients with central lung cancer when compared with the VATS approach?
详细描述
Lung cancer is the leading cause of cancer-related deaths worldwide. Approximately 85% of lung cancer is non-small-cell lung cancer (NSCLC). Nowadays, radical surgery resection remains the recommended local treatment for resectable NSCLC, and bronchial and/or pulmonary artery sleeve lobectomy have been proven to be preferred surgical approaches for patients with centrally located lung cancer when compared with traditional pneumonectomy. The long-term survival and perioperative outcomes of sleeve lobectomy in robotic-assisted thoracic surgery (RATS) and video-assisted thoracic surgery (VATS) for central lung cancer were found to be comparable in a few retrospective studies with a limited number of participants. Still, they have not been investigated in the high-volume cohort setting.
Thus, the investigators conducted the multicenter observational cohort study to investigate if RATS sleeve lobectomy was non-inferior to VATS in patients with centrally located NSCLC and to evaluate the long-term survival and perioperative outcomes of sleeve lobectomy in these two regular minimally invasive surgical techniques.
Participants with centrally located primary NSCLC receiving bronchial sleeve resection with or without pulmonary artery angioplasty in minimally invasive approaches (RATS or VATS) between January 2015 and September 2024 were retrospectively identified and enrolled from the institutional database.
In this study, the investigators will focus on the 3-year overall survival (OS) and recurrence-free survival (RFS) of the patients between the two groups (RATS vs. VATS) for the comparison of the long-term oncologic outcomes in the propensity score matching method. Meanwhile, the perioperative outcomes will be investigated between RATS versus VATS sleeve lobectomy, including but not limited to intraoperative blood loss, operative time, length of hospital stay, postoperative drainage, postoperative complications, perioperative mortality, number of dissected lymph nodes, and margin status. In addition, this study will also try to explore the learning curve for RATS sleeve lobectomy and assess the safety and feasibility of minimally invasive sleeve lobectomy in specific patient populations, such as NSCLC patients following neoadjuvant therapy or those with clinical mediastinal lymph node metastasis. Furthermore, the study is designed to summarize the key surgical techniques and practice skills in minimally invasive thoracic surgery to promote technical improvements.
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
- •Age ≥ 18 years;
- •Clinically suspected lung cancer with a high likelihood of undergoing sleeve lobectomy;
- •Postoperative histopathological diagnosis confirms non-small cell lung cancer (NSCLC);
- •No history of malignancy within the past 5 years;
- •Signed informed consent agreeing to participate in this study.
排除标准
- •Unable to undergo surgical resection due to surgical contraindications;
- •Postoperative pathology does not confirm non-small cell lung cancer (NSCLC), including but not limited to benign lesions, small cell lung cancer, metastatic tumors, or an insufficient or indeterminate histopathology report;
- •History of malignancy within the past 5 years;
- •Unable to obtain follow-up data;
- •Refusal to sign the informed consent or withdrawal of consent.
研究组 & 干预措施
Lung cancer cohort of sleeve lobectomy in minimally invasive surgical approaches
This lung cancer cohort will retrospectively identify and enroll the participants with centrally located primary NSCLC receiving bronchial sleeve resection with or without pulmonary artery angioplasty in minimally invasive approaches (RATS or VATS) between January 2015 and September 2024 from the institutional databases. The choice of minimally invasive surgical approaches depends on the willingness of the surgeons and the participants in this study.
干预措施: RATS Group (Procedure)
Lung cancer cohort of sleeve lobectomy in minimally invasive surgical approaches
This lung cancer cohort will retrospectively identify and enroll the participants with centrally located primary NSCLC receiving bronchial sleeve resection with or without pulmonary artery angioplasty in minimally invasive approaches (RATS or VATS) between January 2015 and September 2024 from the institutional databases. The choice of minimally invasive surgical approaches depends on the willingness of the surgeons and the participants in this study.
干预措施: VATS group (Procedure)
结局指标
主要结局
3-year RFS
时间窗: 3 years
In this study, the investigators will focus on the 3-year recurrence-free survival (RFS) of the participants between the two groups (RATS vs. VATS) for the comparison of the long-term oncologic outcomes, as the primary outcome.
次要结局
- 3-year OS(3 years)