跳至主要内容
临床试验/NCT07135856
NCT07135856招募中不适用

Comparative Analysis of Minimally Invasive and Open Sleeve Lobectomy Following Neoadjuvant Therapy in NSCLC: A Multicenter Retrospective Evaluation of Surgical Outcomes

Shanghai Chest Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
3-year RFS

研究概览

简要总结

The goal of this observational, retrospective, multicenter cohort study is to evaluate the surgical and oncologic outcomes of sleeve lobectomy performed via minimally invasive (RATS/VATS) or open thoracotomy approaches in patients with non-small cell lung cancer (NSCLC) who have undergone neoadjuvant therapy, including chemotherapy, immunotherapy, or combination regimens. The main questions this study aims to answer are:

  • Does minimally invasive sleeve lobectomy result in comparable or improved perioperative and postoperative outcomes compared to open thoracotomy following neoadjuvant treatment in NSCLC?
  • Does surgical approach influence oncologic endpoints such as margin status, lymph node dissection, recurrence-free survival, and overall survival? This research addresses a critical gap in the thoracic oncology field by evaluating the safety, complexity, and efficacy of advanced surgical techniques in the context of evolving multimodal therapy paradigm. Findings may inform clinical decision-making and optimize patient selection in an era of increasing use of neoadjuvant strategies for resectable NSCLC.

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

入选标准

  • Age ≥ 18 years
  • Histologically confirmed NSCLC
  • Undergoing sleeve lobectomy with curative intent
  • Receipt of neoadjuvant therapy (chemotherapy, immunotherapy, target therapy, etc.)
  • Surgical approach: either minimally invasive (VATS or RATS) or open thoracotomy
  • Availability of complete perioperative and follow-up data (minimum 12-month follow-up or until death)
  • Signed informative consent

排除标准

  • Sublobar resections (e.g., segmentectomy) or pneumonectomy
  • Absence of neoadjuvant therapy
  • Purely diagnostic surgical procedures
  • Incomplete medical records or lost to follow-up
  • Metastatic (stage IV) disease at time of surgery

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 (open vs. MIS) for the comparison of the long-term oncologic outcomes, as the primary outcome.

次要结局

  • 3-year OS(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xinghua Cheng

Director, Head of Oncology Surgery, Clinical Professor

Shanghai Chest Hospital

研究点 (1)

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