Neoadjuvant Chemoimmunotherapy, Robotic Surgery, Sleeve Lobectomy, Stage IIB-III NSCLC
Conditions
Keywords
stage IIB-III NSCLC, sleeve lobectomy, robotic surgery, neoadjuvant chemoimmunotherapy, perioperative outcomes, difficulty of surgery
Brief summary
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.
Detailed description
Please check the details of this study on Clinicaltrials.gov
Interventions
PROCEDURERobot-assisted thoracoscopic surgery (RATS) sleeve lobectomy
After the neoadjuvant treatment reaches the expected effect (partial remission, complete remission, or stable disease), the patients will undergo RATS sleeve lobectomy.
Sponsors
Shanghai Chest Hospital
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
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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) * Planned neoadjuvant chemo-immunotherapy (PD-1/PD-L1 inhibitor + platinum doublet；additional neoadjuvant thoracic radiotherapy is allowed) * Planned curative-intent RATS sleeve lobectomy with systematic nodal dissection * Baseline and restaging imaging per protocol (CT ± PET-CT) * Complete 30-day postoperative follow-up * Ability to provide informed consent
Exclusion criteria
* 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. * Clear unresectability at restaging (e.g., multistation bulky N2/N3 not responding; unreconstructable T4 invasion) or MDT consensus against surgery. * Contraindication to general anesthesia or prohibitive cardiopulmonary risk precluding sleeve/lobectomy. * Active autoimmune disease requiring systemic immunosuppression within 2 years, prior organ transplant, or history of grade ≥2 pneumonitis/ILD * Uncontrolled infection, pregnancy or breastfeeding, or any intercurrent illness that would compromise participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unsuccessful RATS Sleeve Lobectomy | From enrollment to the end of treatment at 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Surgical Difficulty Assessment | From enrollment to the end of treatment at 1 day | 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. |
| Specific Difficulty Factors | From enrollment to the end of treatment at 1 day | 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 |
| Fissure Development Grade | From enrollment to the end of treatment at 1 day | 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. |
| Pleural Adhesions | From enrollment to the end of treatment at 1 day | 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% |
| Hilar Fibrosis | From enrollment to the end of treatment at 1 day | 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. |
| Lymph Node Fusion | From enrollment to the end of treatment at 1 day | 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. |
| Vascular Inflammatory Reaction / Edema | From enrollment to the end of treatment at 1 day | 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. |
| Need for Proximal Vascular Control | From enrollment to the end of treatment at 1 day | No Yes |
| Length of stay (LOS) | From enrollment to the end of treatment up to 30 days | 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. |
Countries
China, France, Italy
Contacts
CONTACTZhigang Li, MD, PhD
CONTACTLin Huang, MD, PhD
STUDY_CHAIRZhigang Li, MD, PhD
Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School
Outcome results
None listed