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Recruiting NCT07065604

Tubeless VATS for Mediastinal Neoplasm

No phase Interventional Mediastinal Neoplasm VATS Tubeless Non-intubated Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-intubated VATS for mediastinal neoplasm, Intubated VATS for mediastinal neoplasm.
Who it may be relevant to
Registry conditions: Mediastinal Neoplasm, VATS, Tubeless, Non-intubated Anesthesia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized Controlled Trial of Non-intubated Versus Intubated VATS for Mediastinal Neoplasm

Overview

In recent year, non-intubated anesthesia had emerged as an available and promising alternative for thoracic procedure. However, its safety and feasibility in video-assisted thoracoscopic surgery (VATS) for mediastinal neoplasm remain controversial. This randomized controlled trial is designed to evaluate the impact of the non-intubated approach on surgical and perioperative outcomes in patients undergoing mediastinal neoplasm resection.

Detailed description

Non-intubated anesthesia has gained widespread adoption in recent years, representing a significant advancement in both thoracic surgery and anesthetic practice. The surgical safety and feasibility of tubeless VATS for mediastinal neoplasm has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial. Accordingly, this randomized controlled trial aims to evaluate whether the non-intubated approach provides comparable short-term and long-term outcomes to the conventional intubated technique in VATS for mediastinal neoplasm resection.

Interventions

  • Procedure Non-intubated VATS for mediastinal neoplasm
    Non-intubated VATS for mediastinal neoplasm
  • Procedure Intubated VATS for mediastinal neoplasm
    Intubated VATS for mediastinal neoplasm

Primary outcome measures

  • Conversion rate to open surgery [Time frame: postoperative in-hospital stay up to 30 days]
  • Conversion rate to intubated anesthesia [Time frame: postoperative in-hospital stay up to 30 days]
  • Postoperative complication rate [Time frame: postoperative in-hospital stay up to 30 days]
Secondary outcome measures (9)
  • R0 rate [Time frame: postoperative in-hospital stay up to 30 days]
  • Operation time [Time frame: postoperative in-hospital stay up to 30 days]
  • Intraoperative bleeding loss [Time frame: postoperative in-hospital stay up to 30 days]
  • ICU stay [Time frame: postoperative in-hospital stay up to 30 days]
  • Hospital stay [Time frame: postoperative in-hospital stay up to 30 days]
  • Volume of postoperative drainage [Time frame: postoperative in-hospital stay up to 30 days]
  • 1-year disease-free survival (DFS) [Time frame: 1 year after surgery]
  • 1-year overall survival(OS) [Time frame: 1 year after surgery]
  • Quality of life (QOL) at 3 month [Time frame: Quality of life (QOL) at 3 months post-discharge, as measured by [specify QOL scale], reflecting patient-reported physical, emotional, and social well-being.]

Eligibility criteria

Inclusion criteria

  • Mediastinal neoplasm was diagnosed by chest enhanced CT
  • The patients with age ≥ 18 and ≤ 80 years old
  • The patients whose tumor diameter was <6 cm
  • ASA grade: I-III
  • The patients should understand the research and sign the informed consent

Exclusion criteria

  • Imaging examinations revealed that the tumor had invaded adjacent organs, with evidence of pleural or pericardial dissemination, as well as lymphatic and/or hematogenous metastases
  • Patients with a confirmed history of congestive heart failure, poorly controlled angina despite medical therapy, electrocardiogram-confirmed myocardial infarction with transmural involvement, uncontrolled hypertension, clinically significant valvular heart disease, or high-risk arrhythmias not adequately managed
  • Patients with concurrent active malignancies

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • the First Affiliated Hospital of Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT07065604 · ES-2025-074-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗