RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorShanghai Chest Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy
Procedure/SurgeryAfter the neoadjuvant treatment reaches the expected effect (partial remission, complete remission, or stable disease), the patients will undergo RATS sleeve lobectomy.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: ⅡB-Ⅲ NSCLC following Neo-Chemo-IO & RATS sleeve lobectomy1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 4 weeksSecondary outcomes
1
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 day2
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 day3
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 day4
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 dayOther outcomes
1
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.
Time frame
From enrollment to the end of treatment up to 90 days2
30- and 90-day mortality
30- and 90-day mortality was defined as all-cause death occurring within 30 days and 90 days after the date of surgery, respectively.
Time frame
From enrollment to the end of treatment up to 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Chest Hospital
Lead sponsor
The Affiliated Hospital of Qingdao University
Collaborator
Fujian Medical University Union Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Jiangsu Cancer Institute & Hospital
Collaborator
Shenzhen People's Hospital
Collaborator
University Hospital, Rouen
Collaborator
Hopital Saint Joseph Marseille
Collaborator
Azienda Ospedaliera Cosenza
Collaborator
Source ClinicalTrials.gov