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NCT Number: NCT07065604

Tubeless VATS for Mediastinal Neoplasm

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Non-intubated VATS for mediastinal neoplasm

Procedure

Non-intubated VATS for mediastinal neoplasm

Intubated VATS for mediastinal neoplasm

Procedure

Intubated VATS for mediastinal neoplasm

Primary outcomes

  1. Conversion rate to open surgery

    Time frame: postoperative in-hospital stay up to 30 days

    Proportion of patients requiring conversion from VATS to open surgery.

  2. Conversion rate to intubated anesthesia

    Time frame: postoperative in-hospital stay up to 30 days

    Proportion of patients requiring conversion from non-intubated approach to intubated anesthesia

  3. Postoperative complication rate

    Time frame: postoperative in-hospital stay up to 30 days

    Incidence and severity of treatment-related adverse events, classified by Clavien-Dindo for surgical complications and CTCAE v5.0 for systemic adverse events.

Secondary outcomes

  1. R0 rate

    Time frame: postoperative in-hospital stay up to 30 days

    R0 resection rate

  2. Operation time

    Time frame: postoperative in-hospital stay up to 30 days

    Operative time was defined as the time between the start of the surgery (incision) and the finish of surgery (closure of the skin).

  3. Intraoperative bleeding loss

    Time frame: postoperative in-hospital stay up to 30 days

    The volume of bleeding during the surgery.

  4. ICU stay

    Time frame: postoperative in-hospital stay up to 30 days

    ICU stay (in days), defined as the duration from ICU admission post-surgery to ICU discharge.

  5. Hospital stay

    Time frame: postoperative in-hospital stay up to 30 days

    Hospital stay, defined as the duration from the day of surgery to the day of discharge.

  6. Volume of postoperative drainage

    Time frame: postoperative in-hospital stay up to 30 days

    Volume of postoperative drainage, measured from the end of surgery until drain removal.

  7. 1-year disease-free survival (DFS)

    Time frame: 1 year after surgery

    1-year disease-free survival (DFS), defined as the percentage of patients alive without evidence of tumor recurrence or progression at 12 months.

  8. 1-year overall survival(OS)

    Time frame: 1 year after surgery

    1-year overall survival(OS), defined as the percentage of patients alive at 12 months from the date of surgery or treatment initiation, irrespective of disease recurrence or progression.

  9. 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.

    3 months after discharge

Study contacts

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

Shuben Li, Deputy Director

CONTACT

[email protected]

86(020) 8306 2114

Sponsors and collaborators

Lead sponsor

Shuben Li

Other

Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

Registry information

Official study title

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

Acronym: NOVA-02

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 15, 2025
Registry last updated
Jul 15, 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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