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

Qualifiers

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 design

Treatments tested in this trial

  • Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

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