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NCT Number: NCT07135856

Sleeve Lobectomy Following Neoadjuvant Therapy in NSCLC

The goal of this observational, retrospective, multicenter cohort study is to evaluate the surgical and oncologic outcomes of sleeve lobectomy performed via minimally invasive (RATS/VATS) or open thoracotomy approaches in patients with non-small cell lung cancer (NSCLC) who have undergone neoadjuvant therapy, including chemotherapy, immunotherapy, or combination regimens. The main questions this study aims to answer are:

* Does minimally invasive sleeve lobectomy result in comparable or improved perioperative and postoperative outcomes compared to open thoracotomy following neoadjuvant treatment in NSCLC? * Does surgical approach influence oncologic endpoints such as margin status, lymph node dissection, recurrence-free survival, and overall survival? This research addresses a critical gap in the thoracic oncology field by evaluating the safety, complexity, and efficacy of advanced surgical techniques in the context of evolving multimodal therapy paradigm. Findings may inform clinical decision-making and optimize patient selection in an era of increasing use of neoadjuvant strategies for resectable NSCLC.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoadjuvant Therapy Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

Xinghua Cheng, M.D., Ph.D.

CONTACT

[email protected]

86+17701681215

Zhebing Lin, M.D.

CONTACT

[email protected]

86+18957727196

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Histologically confirmed NSCLC
  • Undergoing sleeve lobectomy with curative intent
  • Receipt of neoadjuvant therapy (chemotherapy, immunotherapy, target therapy, etc.)
  • Surgical approach: either minimally invasive (VATS or RATS) or open thoracotomy
  • Availability of complete perioperative and follow-up data (minimum 12-month follow-up or until death)
  • Signed informative consent

Exclusion criteria

  • Sublobar resections (e.g., segmentectomy) or pneumonectomy
  • Absence of neoadjuvant therapy
  • Purely diagnostic surgical procedures
  • Incomplete medical records or lost to follow-up
  • Metastatic (stage IV) disease at time of surgery

Treatment and study plan

Primary outcomes

  1. 3-year RFS

    Time frame: 3 years

    In this study, the investigators will focus on the 3-year recurrence-free survival (RFS) of the participants between the two groups (open vs. MIS) for the comparison of the long-term oncologic outcomes, as the primary outcome.

Secondary outcomes

  1. 3-year OS

    Time frame: 3 years

    The investigators will also focus on the 3-year overall survival (OS) of the participants between the two groups (open vs. MIS) for the comparison of the long-term oncologic outcomes, as the secondary outcome.

Other outcomes

  1. Intraoperative bleeding

    Time frame: up to 90 days

    The intraoperative bleeding will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes, measured in milliliter (mL).

  2. Surgery duration

    Time frame: up to 90 days

    The surgery duration will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes, measured in minute (min).

  3. Postoperative hospital stay

    Time frame: up to 90 days

    The postoperative hospital stay will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes, measured in day.

  4. Postoperative complications

    Time frame: up to 90 days

    The postoperative complications will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes, showed in the number of the participants who occurred postoperative complications (n).

  5. Perioperative mortality

    Time frame: up to 90 days

    The perioperative mortality will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes, showed in the number of the participants who died within 90 days of surgery (n).

  6. Number of dissected lymph nodes

    Time frame: up to 90 days

    The number of dissected lymph nodes will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes (n).

  7. Number of dissected lymph node stations

    Time frame: up to 90 days

    The number of dissected lymph node stations will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes (n).

  8. Margin status

    Time frame: up to 90 days

    The margin status will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes, showed in the number of the participants who had the positive or negative surgical margins (n).

  9. Postoperative ICU Length of Stay

    Time frame: up to 90 days

    The postoperative ICU length stay will be investigating between open versus MlS sleeve lobectomy as one of the perioperative outcomes, measured in days. If no ICU admission occurs, length of stay is recorded as 0 days.

  10. Postoperative chest tube drainage duration

    Time frame: up to 90 days

    The postoperative chest tube drainage duration will be investigating between open versus MlS sleeve lobectomy as one of the perioperative outcomes, measured in days.

  11. Postoperative pain scores

    Time frame: up to 90 days

    The postoperative pain scale will be investigating between open versus MlS sleeve lobectomy as one of the perioperative outcomes, measured with the Numeric Rating Scale (0-10) on postoperative days 1 and 2, and highest score during hospitalization.

  12. Conversion rate to Thoracotomy

    Time frame: at surgery

    The conversion rate from minimally invasive (VATS or RATS) cases to open thoracotomy will be showed in numbers.

Study contacts

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

Xinghua Cheng, M.D., Ph.D.

CONTACT

[email protected]

86+17701681215

Zhebing Lin, M.D.

CONTACT

[email protected]

86+18957727196

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Sir Run Run Shaw Hospital
  • University of Padova

Registry information

Official study title

Comparative Analysis of Minimally Invasive and Open Sleeve Lobectomy Following Neoadjuvant Therapy in NSCLC: A Multicenter Retrospective Evaluation of Surgical Outcomes

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Dec 31, 2025

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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