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NCT Number: NCT07541521

RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC

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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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Medical University Union Hospital, Fuzhou, Fujian, China

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About this study

Please check the details of this study on Clinicaltrials.gov

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Unsuccessful 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.

Secondary outcomes

  1. Subjective Surgical Difficulty Assessment

    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.

  2. Specific Difficulty Factors

    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

  3. Fissure Development Grade

    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.

  4. Pleural Adhesions

    Time frame: From enrollment to the end of treatment at 1 day

    • 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.

    • 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%
  5. Hilar Fibrosis

    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.

  6. Lymph Node Fusion

    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.

  7. Vascular Inflammatory Reaction / Edema

    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.

  8. Need for Proximal Vascular Control

    Time frame: From enrollment to the end of treatment at 1 day

    No Yes

  9. Length of stay (LOS)

    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.

Other outcomes

  1. 30- and 90-day readmission rates

    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.

  2. 30- and 90-day mortality

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Huang, MD, PhD

CONTACT

[email protected]

008618116061178

Zhigang Li, MD, PhD

CONTACT

[email protected]

0086-021-22200000

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Collaborators

  • Azienda Ospedaliera Cosenza
  • Fujian Medical University Union Hospital
  • Guangdong Provincial People's Hospital
  • Hopital Saint Joseph Marseille
  • Jiangsu Cancer Institute & Hospital
  • Shenzhen People's Hospital
  • The Affiliated Hospital of Qingdao University
  • Tianjin Medical University Cancer Institute and Hospital
  • University Hospital, Rouen

Registry information

Official study title

Robotic-Assisted Sleeve Lobectomy for Non-Small Cell Lung Cancer After Neoadjuvant Chemoimmunotherapy

Acronym: RIDDLE-NSCLC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

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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