Tubeless AnesthesiaVATS+MWANCT07924280
Clinical Study on Tubeless Anesthesia for Minimally Invasive Surgery Combined With Ablation in Patients With High-Risk Ground-Glass Nodules
A study testing tubeless anesthesia and conventional intubation anesthesia in people with Tubeless Anesthesia and MWA (Microwave Ablation), run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Whether tubeless anesthesia provides clinically superior postoperative symptom recovery (measured by PSA-LUNG) and higher safety in patients undergoing VATS combined with microwave ablation (VATS+MWA) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tubeless Anesthesia, MWA (Microwave Ablation), Ground-glass Nodules (GGNs)
- What is being tested?
- tubeless anesthesia and conventional intubation anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2026to 1 Oct 2027
- 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
- aged ≥ 18 years
- Chest CT revealed ≥2 multiple high-risk pulmonary ground-glass nodules (GGNs) that persisted for over 3 months. Following a multidisciplinary team (MDT) evaluation, these nodules were highly suspicious for malignancy. The nodules were required to meet the following criteria: Imaging criteria: Maximum diameter ≤2 cm and a consolidation-to-tumor ratio (CTR) ≤0.5 on chest CT. Surgical nodule criteria: Deemed amenable to wedge resection via intrathoracic surgical evaluation, with an anticipated surgical margin of ≥2 cm or ≥ the maximum diameter of the nodule. Ablation nodule criteria: Deemed unsuitable for wedge resection via intrathoracic surgical evaluation, primarily due to a location within the inner two-thirds of the lung parenchyma.
- ECOG performance status: 0-1; preoperative systemic organ function was adequate for VATS and ablation.
- ASA physical status: Class I-III
- Preoperative PET-CT or other necessary imaging tests to exclude mediastinal and distant metastasis.
- Expected survival ≥ 6 months; able to complete the study and follow-up as required.
- Participants provided written informed consent and agreed to adhere to study visits, treatments, laboratory tests and related procedures.
Who cannot join
- Prior pulmonary surgery, radiotherapy or other ablation within 3 months.
- Contraindications to surgery, ablation or anesthesia; intolerance to tubeless anesthesia.
- Planned concurrent treatments interfering with study results (e.g., systemic chemotherapy, targeted therapy).
- Primary extrapulmonary malignancies or other active malignant diseases.
- Failure to follow study rules or complete follow-up; refusal to provide informed consent or withdrawal of consent during the study.
- Considered unsuitable for the study by investigators.
- Enrollment in other concurrent clinical trials.
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
Xingyang Xue, PhD, +86-15876522723, xxy1023970@126.com
About this study
Official title: A Multicenter, Prospective Randomized Controlled Trial Evaluating the Efficacy and Safety of Tubeless Anesthesia Versus Conventional Endotracheal Intubation Anesthesia for Thoracoscopic Surgery Combined With Concurrent Microwave Ablation in the Treatment of Multiple High-Risk Ground-Glass Nodules-Patient-Reported Outcomes (PSA-LUNG) as Primary Endpoint
Whether tubeless anesthesia provides clinically superior postoperative symptom recovery (measured by PSA-LUNG) and higher safety in patients undergoing VATS combined with microwave ablation (VATS+MWA)
Read the detailed description
This study is a multicenter, prospective, randomized controlled interventional clinical trial conducted by the Department of Thoracic Surgery at The First Affiliated Hospital of Guangzhou Medical University. The study primarily compares the efficacy and safety of tubeless anesthesia versus conventional endotracheal intubation anesthesia in video-assisted thoracoscopic surgery (VATS) combined with simultaneous microwave ablation (MWA) for the treatment of multiple high-risk pulmonary ground-glass nodules (GGNs), with the Postoperative Symptom Assessment scale for lung cancer surgery (PSA-LUNG)-a patient-reported outcome-as the core evaluation indicator.
A total of 80 patients with multiple high-risk GGNs who meet the inclusion criteria will be randomly assigned in a 1:1 ratio to two groups: the experimental group will undergo VATS combined with MWA under tubeless anesthesia, while the control group will undergo VATS combined with MWA under conventional intubation anesthesia. By assessing the PSA-LUNG score, technical success rate, perioperative complication rate, and postoperative changes in lung function, this study aims to determine whether tubeless anesthesia can provide patients with better postoperative symptom recovery and higher safety. Meanwhile, the dynamic changes in tumor markers will be explored to provide clinical evidence for optimizing perioperative anesthesia strategies in this patient population.
- Conditions
- Tubeless Anesthesia, MWA (Microwave Ablation), Ground-glass Nodules (GGNs), Lung, Simultaneous, VATS (Video-assisted Thoracoscopic Surgery)
- Being tested
- tubeless anesthesia, conventional intubation anesthesia
- Keywords
- Tubeless anesthesia, VATS (video-assisted thoracoscopic surgery), MWA (microwave ablation), Patient-reported outcome (PRO), Simultaneous, High-risk ground-glass nodule (GGN)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tubeless anesthesiaProcedure or surgery
Also called Tubeless
Tubeless (non-intubated) anesthesia: general anesthesia is induced and maintained without endotracheal intubation. The patient breathes spontaneously throughout the procedure. Anesthesia is maintained with intravenous agents (e.g., propofol, remifentanil) combined with regional anesthesia (thoracic paravertebral block or erector spinae plane block) and/or moderate sedation.
conventional intubation anesthesiaProcedure or surgery
Conventional intubation anesthesia: general anesthesia is induced with endotracheal intubation and the patient is mechanically ventilated throughout the procedure. Anesthesia is maintained with intravenous agents (e.g., propofol, remifentanil) and/or inhaled anesthetics, combined with muscle relaxants as needed.
| Study group | Role | What they receive |
|---|---|---|
| VATS combined with simultaneous MWA under conventional intubation anesthesia | Active comparator | conventional intubation anesthesia Receives: Procedure: conventional intubation anesthesia |
| VATS combined with simultaneous MWA under tubeless anesthesia | Experimental | tubeless anesthesia Receives: Procedure: tubeless anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA-LUNG scale score
Follow-up was conducted via in-hospital visits, remote contact and outpatient visits.
Measured: Electronic questionnaires were administered at baseline (preoperatively), early postoperative period (day of surgery, POD 1, discharge day), and weekly within 4 weeks postoperatively. All assessments covered the entire perioperative period.
Secondary outcomes (1)
Pulmonary function test
Pulmonary function test
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start24 Aug 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tubeless AnesthesiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Xingyang, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07924280
- Sponsor's protocol ID
- 20260824
- Acronym
- VATS+MWA
- Status last verified
- Nov 2026
- First submitted
- 15 Oct 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study team has not yet decided whether to share individual participant data. The decision will depend on institutional policy, participant consent, and feasibility of data de-identification. This plan will be updated accordingly.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Randomized Controlled Trial Evaluating the Efficacy and Safety of Tubeless Anesthesia Versus Conventional Endotracheal Intubation Anesthesia for Thoracoscopic Surgery Combined With Concurrent Microwave Ablation in the Treatment of Multiple High-Risk Ground-Glass Nodules-Patient-Reported Outcomes (PSA-LUNG) as Primary Endpoint
- ClinicalTrials.gov ID
- NCT07924280
- Acronym / sponsor ID
- VATS+MWA / 20260824
- Conditions
- Tubeless Anesthesia, MWA (Microwave Ablation), Ground-glass Nodules (GGNs), Lung, Simultaneous, VATS (Video-assisted Thoracoscopic Surgery)
- Keywords
- Tubeless anesthesia, VATS (video-assisted thoracoscopic surgery), MWA (microwave ablation), Patient-reported outcome (PRO), Simultaneous, High-risk ground-glass nodule (GGN)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 9 Nov 2026 (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.
Whether tubeless anesthesia provides clinically superior postoperative symptom recovery (measured by PSA-LUNG) and higher safety in patients undergoing VATS combined with microwave ablation (VATS+MWA)
Detailed description
This study is a multicenter, prospective, randomized controlled interventional clinical trial conducted by the Department of Thoracic Surgery at The First Affiliated Hospital of Guangzhou Medical University. The study primarily compares the efficacy and safety of tubeless anesthesia versus conventional endotracheal intubation anesthesia in video-assisted thoracoscopic surgery (VATS) combined with simultaneous microwave ablation (MWA) for the treatment of multiple high-risk pulmonary ground-glass nodules (GGNs), with the Postoperative Symptom Assessment scale for lung cancer surgery (PSA-LUNG)-a patient-reported outcome-as the core evaluation indicator.
A total of 80 patients with multiple high-risk GGNs who meet the inclusion criteria will be randomly assigned in a 1:1 ratio to two groups: the experimental group will undergo VATS combined with MWA under tubeless anesthesia, while the control group will undergo VATS combined with MWA under conventional intubation anesthesia. By assessing the PSA-LUNG score, technical success rate, perioperative complication rate, and postoperative changes in lung function, this study aims to determine whether tubeless anesthesia can provide patients with better postoperative symptom recovery and higher safety. Meanwhile, the dynamic changes in tumor markers will be explored to provide clinical evidence for optimizing perioperative anesthesia strategies in this patient population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VATS combined with simultaneous MWA under conventional intubation anesthesia | Active comparator | Procedure: conventional intubation anesthesiaconventional intubation anesthesia |
| VATS combined with simultaneous MWA under tubeless anesthesia | Experimental | Procedure: tubeless anesthesiatubeless anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aged ≥ 18 years
- Chest CT revealed ≥2 multiple high-risk pulmonary ground-glass nodules (GGNs) that persisted for over 3 months. Following a multidisciplinary team (MDT) evaluation, these nodules were highly suspicious for malignancy. The nodules were required to meet the following criteria: Imaging criteria: Maximum diameter ≤2 cm and a consolidation-to-tumor ratio (CTR) ≤0.5 on chest CT. Surgical nodule criteria: Deemed amenable to wedge resection via intrathoracic surgical evaluation, with an anticipated surgical margin of ≥2 cm or ≥ the maximum diameter of the nodule. Ablation nodule criteria: Deemed unsuitable for wedge resection via intrathoracic surgical evaluation, primarily due to a location within the inner two-thirds of the lung parenchyma.
- ECOG performance status: 0-1; preoperative systemic organ function was adequate for VATS and ablation.
- ASA physical status: Class I-III
- Preoperative PET-CT or other necessary imaging tests to exclude mediastinal and distant metastasis.
Key exclusion criteria (7 listed)
- Prior pulmonary surgery, radiotherapy or other ablation within 3 months.
- Contraindications to surgery, ablation or anesthesia; intolerance to tubeless anesthesia.
- Planned concurrent treatments interfering with study results (e.g., systemic chemotherapy, targeted therapy).
- Primary extrapulmonary malignancies or other active malignant diseases.
- Failure to follow study rules or complete follow-up; refusal to provide informed consent or withdrawal of consent during the study.
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 |
|---|---|---|
| tubeless anesthesiaAlso: TubelessTubeless (non-intubated) anesthesia: general anesthesia is induced and maintained without endotracheal intubation. The patient breathes spontaneously throughout the procedure. Anesthesia is maintained with intravenous agents (e.g., propofol, remifentanil) combined with regional anesthesia (thoracic paravertebral block or erector spinae plane block) and/or moderate sedation. | Procedure or surgery | VATS combined with simultaneous MWA under tubeless anesthesia |
| conventional intubation anesthesiaConventional intubation anesthesia: general anesthesia is induced with endotracheal intubation and the patient is mechanically ventilated throughout the procedure. Anesthesia is maintained with intravenous agents (e.g., propofol, remifentanil) and/or inhaled anesthetics, combined with muscle relaxants as needed. | Procedure or surgery | VATS combined with simultaneous MWA under conventional intubation anesthesia |
Primary outcome
PSA-LUNG scale score
Time frame: Electronic questionnaires were administered at baseline (preoperatively), early postoperative period (day of surgery, POD 1, discharge day), and weekly within 4 weeks postoperatively. All assessments covered the entire perioperative period.
Follow-up was conducted via in-hospital visits, remote contact and outpatient visits.
1 secondary outcome
Pulmonary function test
Time frame: 1 month after surgery
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 9 Nov 2026.
- Individual participant dataSharing planned: Undecided. The study team has not yet decided whether to share individual participant data. The decision will depend on institutional policy, participant consent, and feasibility of data de-identification. This plan will be updated accordingly.
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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 tubeless anesthesia and conventional intubation anesthesia in people with Tubeless Anesthesia and MWA (Microwave Ablation), run by The First Affiliated Hospital of Guangzhou Medical University 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 7 inclusion and 7 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 9 Nov 2026. 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 Xingyang Xue, PhD (+86-15876522723, xxy1023970@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA-LUNG scale score (time frame: Electronic questionnaires were administered at baseline (preoperatively), early postoperative period (day of surgery, POD 1, discharge day), and weekly within 4 weeks postoperatively. All assessments covered the entire perioperative period.). 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 9 Nov 2026.