Tubeless VATS for Mediastinal Neoplasm (NOVA-02)

Shuben Li

Status: Enrolling

Conditions: Tubeless; Non-intubated Anesthesia; VATS; Mediastinal Neoplasm

Treatments: Procedure: Intubated VATS for mediastinal neoplasm; Procedure: Non-intubated VATS for mediastinal neoplasm

Study type: Interventional

Funder types: Other

Identifiers

NCT07065604

ES-2025-074-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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
2. 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
3. Patients with concurrent active malignancies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Non-intubated group

Experimental group

Description:

Patients received tubeless VATS for mediastinal neoplasm

Treatment:

Procedure: Non-intubated VATS for mediastinal neoplasm

Intubated group

Active Comparator group

Description:

Patients received VATS mediastinal neoplasm resection under intubated general anesthesia.

Treatment:

Procedure: Intubated VATS for mediastinal neoplasm