About this trial
The goal of this multicenter prospective observational study is to learn about the surgical difficulty and outcomes of robotic-assisted sleeve lobectomy in patients with non-small cell lung cancer (NSCLC) after neoadjuvant chemoimmunotherapy. The main questions it aims to answer are:
What is the rate of unsuccessful robotic-assisted sleeve lobectomy after neoadjuvant chemoimmunotherapy?
What factors are associated with unsuccessful surgery?
How do surgeons subjectively assess intraoperative difficulty across multiple dimensions during these procedures?
In this study, unsuccessful surgery is defined as any of the following: conversion to thoracotomy, incomplete (non-R0) resection, or major postoperative complications. Participants who are scheduled to undergo curative-intent robotic-assisted sleeve lobectomy as part of their routine clinical care after neoadjuvant chemoimmunotherapy will be enrolled from multiple centers. Clinical, intraoperative, pathological, and short-term postoperative data will be collected prospectively. In addition, surgeons will be asked to provide a multidimensional subjective assessment of intraoperative difficulty, including factors such as pleural adhesions, hilar fibrosis, nodal matting, fissure completeness, and vascular inflammation or edema, to better characterize the technical challenges of surgery and their association with perioperative outcomes.
Eligibility criteria
Qualifiers
Age ≥18 years
ECOG performance status 0-2
Histologically confirmed NSCLC
AJCC 9th clinical stage IIB-III, M0, deemed resectable or potentially resectable by the multidisciplinary tumour discussion (MDT)
Disqualifiers
Metastatic disease (M1) at baseline or on restaging.
No immunotherapy component in neoadjuvant regimen (pure chemotherapy) .
Prior systemic therapy or thoracic radiotherapy for the current cancer before starting chemo-IO.
Palliative intent or planned non-anatomic resection only (e.g., wedge) when sleeve/lobectomy is indicated oncologically.
Trial design
Treatments tested in this trial
- Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy
Treatment groups
Sponsors and collaborators
Shanghai Chest Hospital
Lead sponsor
The Affiliated Hospital of Qingdao University
Collaborator
Fujian Medical University Union Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Jiangsu Cancer Institute & Hospital
Collaborator
Shenzhen People's Hospital
Collaborator
University Hospital, Rouen
Collaborator
Hopital Saint Joseph Marseille
Collaborator
Azienda Ospedaliera Cosenza
Collaborator