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| Name | Class |
|---|---|
| The Affiliated Hospital of Qingdao University | OTHER |
| Fujian Medical University Union Hospital | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| â…¡B-â…¢ NSCLC following Neo-Chemo-IO & RATS sleeve lobectomy | All patients in this cohort will receive neoadjuvant chemo-immunotherapy (Neo-Chemo-IO) first for clinical stage IIB-III non-small cell lung cancer ( NSCLC), followed by robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy | Procedure | After the neoadjuvant treatment reaches the expected effect (partial remission, complete remission, or stable disease), the patients will undergo RATS sleeve lobectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Unsuccessful 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. | From enrollment to the end of treatment at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 30- and 90-day readmission rates | 30- and 90-day readmission rates were defined as the proportion of patients who were readmitted to any hospital within 30 days and 90 days after the initial discharge, respectively. | From enrollment to the end of treatment up to 90 days |
| 30- and 90-day mortality |
Inclusion Criteria:
Exclusion Criteria:
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The study population will include adult patients aged ≥18 years with pathologically or clinically diagnosed stage IIB-III non-small cell lung cancer (NSCLC), no distant metastasis (M0), and no contraindications to neoadjuvant chemoimmunotherapy or surgery. Participants will be selected from patients planned to undergo neoadjuvant chemoimmunotherapy followed by curative-intent robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy. Relevant perioperative, pathological, and postoperative follow-up data will be collected prospectively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhigang Li, MD, PhD | Contact | 0086-021-22200000 | zhigang.li@shsmu.edu.cn | |
| Lin Huang, MD, PhD | Contact | 008618116061178 | dr.huang.lin@shsmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhigang Li, MD, PhD | Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39168279 | Background | Chu NQ, Tan KS, Dycoco J, Adusumilli PS, Bains MS, Bott MJ, Downey RJ, Gray KD, Huang J, Isbell JM, Molena D, Sihag S, Rocco G, Jones DR, Park BJ, Rusch VW. Determinants of successful minimally invasive surgery for resectable non-small cell lung cancer after neoadjuvant therapy. J Thorac Cardiovasc Surg. 2025 Mar;169(3):753-762.e6. doi: 10.1016/j.jtcvs.2024.08.012. Epub 2024 Aug 20. | |
| 35190177 |
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| Tianjin Medical University Cancer Institute and Hospital |
| OTHER |
| Jiangsu Cancer Institute & Hospital | OTHER |
| Shenzhen People's Hospital | OTHER |
| University Hospital, Rouen | OTHER |
| Hopital Saint Joseph Marseille | UNKNOWN |
| Azienda Ospedaliera Cosenza | OTHER |
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| 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 |
| 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. | From enrollment to the end of treatment at 1 day |
| Pleural Adhesions |
| 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. | 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. | 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. | From enrollment to the end of treatment at 1 day |
| Need for Proximal Vascular Control | No Yes | 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. | From enrollment to the end of treatment up to 30 days |
30- and 90-day mortality was defined as all-cause death occurring within 30 days and 90 days after the date of surgery, respectively. |
| From enrollment to the end of treatment up to 90 days |
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| Shenzhen People's Hospital | Recruiting | Shenzhen | Guangdong | 518020 | China |
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| Jiangsu Cancer Institute & Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
|
| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | 266000 | China |
|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjing | Tianjing | 300060 | China |
|
| Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School | Recruiting | Shanghai | 200030 | China |
|
| Hôpital Saint Joseph Marseille | Recruiting | Marseille | 13001 | France |
|
| University Hospital, Rouen | Recruiting | Rouen | 76000 | France |
|
| Azienda Ospedaliera di Cosenza | Recruiting | Cosenza | 87100 | Italy |
|
| Background |
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| 40923935 | Background | Cooper AJ, Garbo E, Arfe A, Conroy M, Shaverdian N, Bott M, Gorria T, Pecci F, Aldea M, Anagnostou V, Schoenfeld A, Gomez D, Forde PM, Awad MM, Jones DR, Ricciuti B, Chaft JE. Real-world outcomes of neoadjuvant chemoimmunotherapy in patients with nonsmall cell lung cancer: Predictors of surgery, pathologic complete response, and event-free survival. Cancer. 2025 Sep 15;131(18):e70081. doi: 10.1002/cncr.70081. |
| 40716726 | Background | Kneuertz PJ, Villamizar N, Altorki NK, Phillips JD, Schnorr P, Jones D, Scott S, D'Souza DM, Baiu I, Abdel-Rasoul M, Schmidt J, Nguyen DM, Merritt RE. Minimally invasive resection of non-small cell lung cancer after chemoimmunotherapy: A multicenter study in academic hospitals. J Thorac Cardiovasc Surg. 2025 Dec;170(6):1803-1812.e2. doi: 10.1016/j.jtcvs.2025.07.030. Epub 2025 Jul 25. |
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