RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC (RIDDLE-NSCLC)

April 16, 2026 updated by: Zhigang Li, Shanghai Chest Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Please check the details of this study on Clinicaltrials.gov

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School
        • Contact:
        • Contact:
          • Lin Huang, MD, PhD
          • Phone Number: 0086-18116061178
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518020
        • Recruiting
        • Shenzhen People's Hospital
        • Contact:
          • Guangsuo Wang, MD, PhD
          • Phone Number: 0086-0755-25533018
          • Email: 908611104@qq.com
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Jiangsu Cancer Institute & Hospital
        • Contact:
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
    • Tianjing
      • Tianjing, Tianjing, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
  • France
      • Marseille, France, 13001
      • Rouen, France, 76000
        • Recruiting
        • University Hospital, Rouen
        • Contact:
  • Italy
      • Cosenza, Italy, 87100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ⅡB-Ⅲ 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.
Procedure: Robot-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 1 day
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
From enrollment to the end of treatment at 1 day
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.
From enrollment to the end of treatment at 1 day
Pleural Adhesions
Time Frame: 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%
From enrollment to the end of treatment at 1 day
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.
From enrollment to the end of treatment at 1 day
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.
From enrollment to the end of treatment at 1 day
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.
From enrollment to the end of treatment at 1 day
Need for Proximal Vascular Control
Time Frame: From enrollment to the end of treatment at 1 day
No Yes
From enrollment to the end of treatment at 1 day
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.
From enrollment to the end of treatment up to 30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment up to 90 days
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.
From enrollment to the end of treatment up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Collaborators

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

Investigators

  • Study Chair: Zhigang Li, MD, PhD, Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 13, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IS26045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Robotic Surgery

Clinical Trials on Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe