RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC

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.

NCT Number	NCT07541521
Lead Sponsor	Shanghai Chest Hospital Collaborators: The Affiliated Hospital of Qingdao University, Fujian Medical University Union Hospital, Guangdong Provincial People's Hospital, Tianjin Medical University Cancer Institute and Hospital, Jiangsu Cancer Institute & Hospital, Shenzhen People's Hospital, University Hospital, Rouen, Hopital Saint Joseph Marseille, Azienda Ospedaliera Cosenza
Conditions	Stage IIB-III NSCLC, Sleeve Lobectomy, Robotic Surgery, Neoadjuvant Chemoimmunotherapy
Enrollment	100 participants
Start Date	2026-04-13
Primary Completion	2027-05-30 (estimated)
Study Completion	2027-05-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-21