Tubeless VATS for Mediastinal Neoplasm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-26

Study Completion Date

2028-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Mediastinal Neoplasm VATS Tubeless Non-intubated Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-intubated group

Patients received tubeless VATS for mediastinal neoplasm

Group Type EXPERIMENTAL

Non-intubated VATS for mediastinal neoplasm

Intervention Type PROCEDURE

Non-intubated VATS for mediastinal neoplasm

Intubated group

Patients received VATS mediastinal neoplasm resection under intubated general anesthesia.

Group Type ACTIVE_COMPARATOR

Intubated VATS for mediastinal neoplasm

Intervention Type PROCEDURE

Intubated VATS for mediastinal neoplasm

Interventions

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Non-intubated VATS for mediastinal neoplasm

Intervention Type PROCEDURE

Intubated VATS for mediastinal neoplasm

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No