Mediastinal NeoplasmNOVA-02NCT07065604
Tubeless VATS for Mediastinal Neoplasm
A study testing Non-intubated VATS for mediastinal neoplasm and Intubated VATS for mediastinal neoplasm in people with Mediastinal Neoplasm and VATS, run by Shuben Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mediastinal Neoplasm, VATS, Tubeless
- What is being tested?
- Non-intubated VATS for mediastinal neoplasm and Intubated VATS for mediastinal neoplasm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
Official title: A Randomized Controlled Trial of Non-intubated Versus Intubated 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.
Read the 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 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
- Mediastinal Neoplasm, VATS, Tubeless, Non-intubated Anesthesia
- Being tested
- Non-intubated VATS for mediastinal neoplasm, Intubated VATS for mediastinal neoplasm
- Keywords
- Non-intubated Anesthesia, Tubeless, Mediastinal Neoplasm, VATS
- Medical subject headings
- Mediastinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-intubated VATS for mediastinal neoplasmProcedure or surgery
Non-intubated VATS for mediastinal neoplasm
Intubated VATS for mediastinal neoplasmProcedure or surgery
Intubated VATS for mediastinal neoplasm
| Study group | Role | What they receive |
|---|---|---|
| Non-intubated group | Experimental | Patients received tubeless VATS for mediastinal neoplasm Receives: Procedure: Non-intubated VATS for mediastinal neoplasm |
| Intubated group | Active comparator | Patients received VATS mediastinal neoplasm resection under intubated general anesthesia. Receives: Procedure: Intubated VATS for mediastinal neoplasm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate to open surgery
Proportion of patients requiring conversion from VATS to open surgery.
Measured: 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
Measured: 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.
Measured: postoperative in-hospital stay up to 30 days
Secondary outcomes (9)
R0 rate
R0 resection rate
Measured: 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).
Measured: postoperative in-hospital stay up to 30 days
Intraoperative bleeding loss
The volume of bleeding during the surgery.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year after surgery
Quality of life (QOL) at 3 month
3 months after discharge
Measured: Quality of life (QOL) at 3 months post-discharge, as measured by [specify QOL scale], reflecting patient-reported physical, emotional, and social well-being.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start26 Mar 2025
- Primary completion1 May 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shuben Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shuben Li, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065604
- Sponsor's protocol ID
- ES-2025-074-01
- Acronym
- NOVA-02
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Non-intubated Versus Intubated VATS for Mediastinal Neoplasm
- ClinicalTrials.gov ID
- NCT07065604
- Acronym / sponsor ID
- NOVA-02 / ES-2025-074-01
- Conditions
- Mediastinal Neoplasm, VATS, Tubeless, Non-intubated Anesthesia
- Keywords
- Non-intubated Anesthesia, Tubeless, Mediastinal Neoplasm, VATS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Shuben LiUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-intubated group | Experimental | Procedure: Non-intubated VATS for mediastinal neoplasmPatients received tubeless VATS for mediastinal neoplasm |
| Intubated group | Active comparator | Procedure: Intubated VATS for mediastinal neoplasmPatients received VATS mediastinal neoplasm resection under intubated general anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-intubated VATS for mediastinal neoplasmNon-intubated VATS for mediastinal neoplasm | Procedure or surgery | Non-intubated group |
| Intubated VATS for mediastinal neoplasmIntubated VATS for mediastinal neoplasm | Procedure or surgery | Intubated group |
Primary outcome
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.
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
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.
9 secondary outcomes
R0 rate
Time frame: postoperative in-hospital stay up to 30 days
Operation time
Time frame: postoperative in-hospital stay up to 30 days
Intraoperative bleeding loss
Time frame: postoperative in-hospital stay up to 30 days
ICU stay
Time frame: postoperative in-hospital stay up to 30 days
Hospital stay
Time frame: postoperative in-hospital stay up to 30 days
Volume of postoperative drainage
Time frame: postoperative in-hospital stay up to 30 days
1-year disease-free survival (DFS)
Time frame: 1 year after surgery
1-year overall survival(OS)
Time frame: 1 year after surgery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-intubated VATS for mediastinal neoplasm and Intubated VATS for mediastinal neoplasm in people with Mediastinal Neoplasm and VATS, run by Shuben Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuben Li, Deputy Director (86(020) 8306 2114, 13500030280@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate to open surgery (time frame: postoperative in-hospital stay up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.