Sleeve Lobectomy Following Neoadjuvant Therapy in NSCLC

ConditionsLung Cancer Neoadjuvant Therapy

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorShanghai Chest Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Histologically confirmed NSCLC

Undergoing sleeve lobectomy with curative intent

Receipt of neoadjuvant therapy (chemotherapy, immunotherapy, target therapy, etc.)

Disqualifiers

Sublobar resections (e.g., segmentectomy) or pneumonectomy

Absence of neoadjuvant therapy

Purely diagnostic surgical procedures

Incomplete medical records or lost to follow-up

Trial population

The study will involve multiple thoracic surgery centers with experience in advanced surgical techniques for lung cancer, including sleeve resections and neoadjuvant management. Each center will contribute anonymized data from eligible cases, in accordance with local ethical approvals and data protection regulations.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants

are grouped into 2 trial groups

Group A: Thoracotomy sleeve lobectomy

Group B: MIS sleeve lobectomy

Trial outcomes

Primary outcomes

3-year RFS

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.

Time frame

3 years

Secondary outcomes

3-year OS

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.

Time frame

3 years

Other outcomes

Intraoperative bleeding

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

Time frame

up to 90 days

Surgery duration

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

Time frame

up to 90 days

Postoperative hospital stay

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

Time frame

up to 90 days

Postoperative complications

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).

Time frame

up to 90 days