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Clinical Trial NCT07065604 (NOVA-02) for Mediastinal Neoplasm, VATS, Tubeless, Non-intubated Anesthesia is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Tubeless VATS for Mediastinal Neoplasm (NOVA-02) 132 Randomized
Clinical Trial NCT07065604 (NOVA-02) is an interventional study for Mediastinal Neoplasm, VATS, Tubeless, Non-intubated Anesthesia that is recruiting. It started on 26 March 2025 with plans to enroll 132 participants. Led by Shuben Li, it is expected to complete by 31 August 2028. The latest data from ClinicalTrials.gov was last updated on 15 July 2025.
Brief Summary
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...Show More
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...Show More
Official Title
A Randomized Controlled Trial of Non-intubated Versus Intubated VATS for Mediastinal Neoplasm
Conditions
Mediastinal NeoplasmVATSTubelessNon-intubated AnesthesiaOther Study IDs
- NOVA-02
- ES-2025-074-01
NCT ID Number
Start Date (Actual)
2025-03-26
Last Update Posted
2025-07-15
Completion Date (Estimated)
2028-08-31
Enrollment (Estimated)
132
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Non-intubated Anesthesia
Tubeless
Mediastinal Neoplasm
VATS
Tubeless
Mediastinal Neoplasm
VATS
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalNon-intubated group Patients received tubeless VATS for mediastinal neoplasm | Non-intubated VATS for mediastinal neoplasm Non-intubated VATS for mediastinal neoplasm |
Active ComparatorIntubated group Patients received VATS mediastinal neoplasm resection under intubated general anesthesia. | Intubated VATS for mediastinal neoplasm Intubated VATS for mediastinal neoplasm |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Conversion rate to open surgery | Proportion of patients requiring conversion from VATS to open surgery. | postoperative in-hospital stay up to 30 days |
Conversion rate to intubated anesthesia | Proportion of patients requiring conversion from non-intubated approach to intubated anesthesia | postoperative in-hospital stay up to 30 days |
Postoperative complication rate | Incidence and severity of treatment-related adverse events, classified by Clavien-Dindo for surgical complications and CTCAE v5.0 for systemic adverse events. | postoperative in-hospital stay up to 30 days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
R0 rate | R0 resection rate | postoperative in-hospital stay up to 30 days |
Operation time | Operative time was defined as the time between the start of the surgery (incision) and the finish of surgery (closure of the skin). | postoperative in-hospital stay up to 30 days |
Intraoperative bleeding loss | The volume of bleeding during the surgery. | postoperative in-hospital stay up to 30 days |
ICU stay | ICU stay (in days), defined as the duration from ICU admission post-surgery to ICU discharge. | postoperative in-hospital stay up to 30 days |
Hospital stay | Hospital stay, defined as the duration from the day of surgery to the day of discharge. | postoperative in-hospital stay up to 30 days |
Volume of postoperative drainage | Volume of postoperative drainage, measured from the end of surgery until drain removal. | postoperative in-hospital stay up to 30 days |
1-year disease-free survival (DFS) | 1-year disease-free survival (DFS), defined as the percentage of patients alive without evidence of tumor recurrence or progression at 12 months. | 1 year after surgery |
1-year overall survival(OS) | 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. | 1 year after surgery |
Quality of life (QOL) at 3 month | 3 months after discharge | Quality of life (QOL) at 3 months post-discharge, as measured by [specify QOL scale], reflecting patient-reported physical, emotional, and social well-being. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Shuben LiThe First Affiliated Hospital of Guangzhou Medical UniversityStudy Responsible Party
Shuben Li, Sponsor-Investigator, Deputy Director, The First Affiliated Hospital of Guangzhou Medical University
Study Central Contact
Contact: Shuben Li, Deputy Director, 86(020) 8306 2114, [email protected]
1 Study Locations in 1 Countries
Guangdong
the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510120, China
Recruiting