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RATS Sleeve Lobectomy After Neo-Chemo-IO for Non-Small Cell Lung Cancer

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Summary

NIH's ClinicalTrials.gov has registered NCT07541521, a multicenter prospective observational study evaluating surgical difficulty and outcomes of robotic-assisted thoracoscopic surgery (RATS) sleeve lobectomy in patients with Stage IIB-III non-small cell lung cancer (NSCLC) following neoadjuvant chemoimmunotherapy. The study will track rates of unsuccessful surgery, associated factors, and surgeon-assessed intraoperative difficulty across multiple dimensions.

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What changed

NCT07541521 has been registered on ClinicalTrials.gov as a multicenter prospective observational study of robotic-assisted thoracoscopic surgery (RATS) sleeve lobectomy in NSCLC patients after neoadjuvant chemoimmunotherapy. The study defines unsuccessful surgery as conversion to thoracotomy, incomplete resection, or major postoperative complications, and will prospectively collect clinical, intraoperative, pathological, and short-term postoperative data alongside surgeon-subjective assessments of intraoperative difficulty.

Affected parties include thoracic surgeons and oncologic surgical centers evaluating or performing sleeve lobectomy procedures on patients who have received prior neoadjuvant chemoimmunotherapy. The study's findings may inform surgical decision-making and patient selection criteria for robotic-assisted approaches in this patient population.

Archived snapshot

Apr 21, 2026

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RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC

Observational NCT07541521 Kind: OBSERVATIONAL Apr 21, 2026

Abstract

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.

Conditions: Stage IIB-III NSCLC, Sleeve Lobectomy, Robotic Surgery, Neoadjuvant Chemoimmunotherapy

Interventions: Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy

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Last updated

Classification

Agency
NIH
Published
April 21st, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07541521

Who this affects

Applies to
Clinical investigators Healthcare providers
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Surgical procedure evaluation
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Regulatory Affairs
Topics
Pharmaceuticals Medical Devices

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