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.
Please check the details of this study on Clinicaltrials.gov
Study Type
OBSERVATIONAL
Enrollment
100
After the neoadjuvant treatment reaches the expected effect (partial remission, complete remission, or stable disease), the patients will undergo RATS sleeve lobectomy.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGShenzhen People's Hospital
Shenzhen, Guangdong, China
RECRUITINGJiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, China
RECRUITINGThe Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
RECRUITINGTianjin Medical University Cancer Institute & Hospital
Tianjing, Tianjing, China
RECRUITINGShanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School
Shanghai, China
RECRUITINGHôpital Saint Joseph Marseille
Marseille, France
RECRUITINGUniversity Hospital, Rouen
Rouen, France
RECRUITINGAzienda Ospedaliera di Cosenza
Cosenza, Italy
RECRUITINGUnsuccessful RATS Sleeve Lobectomy
The unsuccessful RATS sleeve lobectomy after neoadjuvant chemo-immunotherapy for NSCLC, defined as conversion to thoracotomy, non-R0 resection, or Clavien-Dindo grade ≥ III postoperative complications.
Time frame: From enrollment to the end of treatment at 4 weeks
Subjective Surgical Difficulty Assessment
The operating surgeon will rate the overall difficulty of the RATS sleeve lobectomy procedure using a 4-point Likert scale immediately after surgery: No difficulty, Some difficulty, Moderate difficulty, Severe difficulty.
Time frame: From enrollment to the end of treatment at 1 day
Specific Difficulty Factors
The operating surgeon will also document the specific intraoperative challenges encountered during the procedure, with the following predefined options: Vascular inflammatory edema and fragility, Dense fibrosis, Pleural adhesions, Lymph node fusion and calcification, Incomplete fissure development
Time frame: From enrollment to the end of treatment at 1 day
Fissure Development Grade
Grade I: Complete fissure; visceral pleura fully separates lobes with no parenchymal fusion at the fissure base; pulmonary artery lies centrally within the fissure. Grade II: Complete fissure line, but parenchymal fusion ≤ 1 cm at the base; pulmonary artery remains visible within the fissure. Grade III: Incomplete fissure; only partial fissure line visible with parenchymal fusion elsewhere; pulmonary artery partially or completely buried within fused parenchyma. Grade IV: Complete fissural fusion with no visible fissure line; pulmonary artery deeply embedded in fused parenchyma requiring tunnel dissection.
Time frame: From enrollment to the end of treatment at 1 day
Pleural Adhesions
1. Definition Dense adhesions: Type II-III adhesions requiring sharp dissection, fibrotic, hypervascular, thick, band-like or sheet-like, prone to bleeding (type II) or fibrotic, scar-like, non-delineated fusion (type III). Overall adhesions: All adhesions including loose and dense. 2. Grading None (0%) Mild: Dense adhesions \< 10% AND overall adhesions \< 30% Moderate: Dense adhesions \< 10% AND overall adhesions \> 70%; OR dense adhesions 10-30% AND overall adhesions 30-70% Severe: Dense adhesions 30-50% AND overall adhesions 30-70%; OR dense adhesions 10-30% AND overall adhesions \> 70% Extremely severe: Dense adhesions \> 50%; OR dense adhesions 30-50% AND overall adhesions \> 70%
Time frame: From enrollment to the end of treatment at 1 day
Hilar Fibrosis
None Mild: Localized fibrosis with clear planes from vital structures; safely dissectible with careful dissection. Moderate: Dense fibrosis tightly adherent to vessels/bronchus; requires advanced sharp dissection and multiple energy devices with risk of bleeding or injury. Severe: Hilar structures encased in a solid fibrotic scar mass; no safe dissection planes identifiable.
Time frame: From enrollment to the end of treatment at 1 day
Lymph Node Fusion
None Mild: Nodes matted but with clear loose fibrous planes from vessels, bronchus, and nerves; completely dissectible without injury to key structures. Moderate: Matted nodes densely adherent to vessel adventitia or bronchial wall with partial loss of dissection plane; may require piecemeal resection or leaving a thin fibrotic layer (confirmed tumor-free); increased bleeding risk. Severe: Nodes fused and frozen to vital structures (main pulmonary artery, SVC, tracheal membrane) with no dissection plane identifiable.
Time frame: From enrollment to the end of treatment at 1 day
Vascular Inflammatory Reaction / Edema
None Mild: Minimal edema with preserved tissue elasticity; clear dissection plane between vascular sheath and surrounding tissue, amenable to blunt dissection. Moderate: Tofu-like or gelatinous tissue with increased fragility and oozing; vascular sheath densely adherent with blurred planes requiring delicate sharp dissection. Severe: Extremely friable, necrotic inflammatory granulation tissue; complete loss of dissection planes; vessel wall fused with surrounding tissue and prone to rupture on dissection.
Time frame: From enrollment to the end of treatment at 1 day
Need for Proximal Vascular Control
No Yes
Time frame: From enrollment to the end of treatment at 1 day
Length of stay (LOS)
LOS is defined as the total number of night from surgery to hospital discharge, calculated as the interval between the date of surgery and the date of discharge.
Time frame: From enrollment to the end of treatment up to 30 days
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