Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy
ProcedureAfter the neoadjuvant treatment reaches the expected effect (partial remission, complete remission, or stable disease), the patients will undergo RATS sleeve lobectomy.
NCT Number: NCT07541521
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.
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Observational
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Please check the details of this study on Clinicaltrials.gov
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After the neoadjuvant treatment reaches the expected effect (partial remission, complete remission, or stable disease), the patients will undergo RATS sleeve lobectomy.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: From enrollment to the end of treatment at 1 day
Overall adhesions: All adhesions including loose and dense.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 1 day
No Yes
Time frame: 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.
Time frame: From enrollment to the end of treatment up to 90 days
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.
Time frame: From enrollment to the end of treatment up to 90 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.
Contact information is provided by the study sponsor or research team.
Lin Huang, MD, PhD
CONTACT
Zhigang Li, MD, PhD
CONTACT
Shanghai Chest Hospital
Other
Robotic-Assisted Sleeve Lobectomy for Non-Small Cell Lung Cancer After Neoadjuvant Chemoimmunotherapy
Acronym: RIDDLE-NSCLC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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