Tubeless VATS (non‑intubated anesthesia) for mediastinal tumor removal
A Randomized Controlled Trial of Non-intubated Versus Intubated VATS for Mediastinal Neoplasm
This trial will test whether VATS without intubation is as safe and effective as the standard intubated approach for adults having mediastinal tumor surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Guangzhou Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07065604 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares non‑intubated (tubeless) VATS with conventional intubated VATS for resection of mediastinal neoplasms. Eligible adult patients with tumors ≤6 cm and ASA class I–III are randomized to receive either non‑intubated or intubated anesthesia and undergo standard thoracoscopic resection. The study collects perioperative and surgical outcomes (operative time, complications, need for conversion to intubation, length of stay) and includes follow‑up to capture oncologic outcomes. The aim is to determine whether tubeless VATS provides comparable short‑term safety and similar long‑term cancer outcomes to the conventional technique.
Who should consider this trial
Good fit: Adults 18–80 years with a mediastinal neoplasm ≤6 cm on chest CT, ASA I–III, without evidence of adjacent organ invasion or distant metastasis, who can give informed consent.
Not a fit: Patients with tumor invasion of adjacent organs, pleural or pericardial dissemination, lymphatic/hematogenous metastases, concurrent active malignancies, significant uncontrolled cardiac disease, or those outside the 18–80 age range are unlikely to benefit from the tubeless approach.
Why it matters
Potential benefit: If successful, tubeless VATS could reduce anesthesia‑related risks, shorten recovery and hospital stay, and improve patient comfort after mediastinal tumor surgery.
How similar studies have performed: Observational and nonrandomized studies have supported the safety and feasibility of non‑intubated thoracic procedures including VATS, but randomized evidence for mediastinal tumor resections is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou, Guangdong
- the First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Shuben Li, Deputy Director
- Email: 13500030280@163.com
- Phone: 86(020) 8306 2114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.