Patients With Suspected Non-small Cell Lung Cancer (NSCLC) at Clinical Stage T1NCT07327736

Anesthesia Comparison in Early-stage Small NSCLC: A Multicenter RCT

A study testing Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS) in people with Patients With Suspected Non-small Cell Lung Cancer (NSCLC) at Clinical Stage T1, run by Tang-Du Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages Up to 75 years
Conditions the study is for: Patients With Suspected Non-small Cell Lung Cancer (NSCLC) at Clinical Stage T1
What is being tested?: Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 410 participants
Where: No sites listed yet
Study dates: 15 Mar 2026to 31 Dec 2032
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 Up to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Age ≤ 75 years;
Gender is not limited;
Patients with suspected T1 stage non-small cell lung cancer (NSCLC) in preoperative clinical staging, with thin-slice CT showing that the maximum tumor diameter is ≤ 3.0 cm, single or multiple nodules, and the nodules requiring surgical resection are located in the same ipsilateral lung lobe, with the number of nodules resected simultaneously ≤ 3;
American Society of Anesthesiologists (ASA) classification ≤ Grade III (preferably Grade I - II is recommended);
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1;
Body Mass Index (BMI) < 25 kg·m-²;

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Normal cardiopulmonary function: predicted forced expiratory volume in the first second (FEV1%) > 50%, resting blood gas analysis showing arterial oxygen partial pressure (PaO2) ≥ 75 mmHg, arterial carbon dioxide partial pressure (PaCO2) < 45 mmHg; ejection fraction (EF) > 50%, 6-minute walk distance (6MWD) ≥ 350 m;
No severe upper airway lesions, Mallampati classification I - II;
No contraindications related to paravertebral nerve block and intercostal nerve block;
Estimated surgical time ≤ 150 minutes;
Patients have no history of clinically significant cardiac or neurological problems.

Who cannot join

A history of ipsilateral lung surgery;
Interstitial pneumonia, pulmonary fibrosis, severe emphysema, severe chronic obstructive pulmonary disease, acute phase of pulmonary infection, or uncontrolled asthma;
Sleep apnea syndrome with anticipated airway difficulty or difficulty in airway management;
Preoperative complications including coagulation dysfunction, hypoxemia, hypercapnia, or hepatic/renal insufficiency;
Alteration of anesthesia or surgical plan;
Persistent cough or increased risk of high airway secretion reflux;

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Mental disorders, inability to communicate, or refusal to sign the informed consent form;
Participation in other clinical trials within 1 month before this trial;
Those who are deemed unfit to participate in this trial by the researchers.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xiaolong Yan, Doctor of Medicine (M.D.) contact

+8615991269383

yanxiaolong@fmmu.edu.cn

About this study

Official title: Comparison Between Spontaneous Breathing-preserving Anesthesia and Double-lumen Endotracheal Intubation Anesthesia in Early-stage Non-small Cell Lung Cancer With a Diameter of ≤ 3 cm: a Prospective, Multicenter Randomized Controlled Study

This study is a prospective, randomized, controlled study, which intends to enroll patients with suspected early-stage NSCLC (non-small cell lung cancer) with a diameter of ≤ 3 cm as research subjects. The study is conducted in accordance with the Declaration of Helsinki. It has been approved by the Ethics Committee of the Second Affiliated Hospital of Air Force Medical University, and patients or their family members have signed the informed consent form. Patients undergoing VATS (video-assisted thoracic surgery) are enrolled in the Department of Thoracic Surgery of the Second Affiliated Hospital of Air Force Medical University. The patients are randomly divided into two groups: the NIVATS (non-intubated video-assisted thoracic surgery) group and the OLV (one-lung ventilation) group. By observing various perioperative indicators of the patients, the short-term efficacy of the two techniques in patients with early-stage NSCLC is compared, so as to evaluate the safety and effectiveness of the NIVATS surgical treatment method.

Conditions: Patients With Suspected Non-small Cell Lung Cancer (NSCLC) at Clinical Stage T1
Being tested: Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)Procedure or surgery
NIVATS is a special method developed in the past two decades. It means that patients do not undergo tracheal intubation under general anesthesia during the entire surgical process, retaining their spontaneous breathing, but supraglottic airway devices (such as laryngeal masks, high-flow nasal catheters, mask ventilation) can be used to support their breathing. The purpose of this technology is to minimize the impact of general anesthesia, tracheal intubation, mechanical ventilation, etc. on patients.

Study groups in NCT07327736
Study group	Role	What they receive
group A	Experimental	Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS) Receives: Procedure: Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)
group B	Placebo comparator	Tracheal Intubation with One-Lung Ventilation Group (OLV) Receives: Procedure: Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Average postoperative hospital stay
Measured: up to 3 months
Intraoperative opioid consumption
Measured: 1 day

Secondary outcomes (10)

Lung collapse score
Measured: 1 day
Intraoperative blood gas analysis (Q1h)
Measured: 1 day
Conversion to intubation rate
Measured: 1 day
Postoperative awakening time
Measured: 1 day
Time to first ambulation after surgery
Measured: up to 3 months
Ambulation rate within 4 hours after surgery
Measured: up to 3 months
Inflammatory markers (IL-6, peripheral neutrophil-to-lymphocyte ratio)
Measured: up to 3 months
Postoperative drainage volume
Measured: up to 3 months
Incidence of perioperative complications
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: up to 3 months
15 item Quality of Recovery Rating Scale (QoR-15)
Measured: up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202631 Dec 2032

First posted8 Jan 2026
Study start15 Mar 2026 (estimated)
Primary completion30 Jun 2028 (estimated)
Study completion31 Dec 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Patients With Suspected Non-small Cell Lung Cancer (NSCLC) at Clinical Stage T1Studies 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: 410 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07327736
Sponsor's protocol ID: IIT202508-17-KYB-15-XWK
Status last verified: Mar 2026
First submitted: 11 Dec 2025
Last updated: 12 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Pompeo E, Mineo D, Rogliani P, Sabato AF, Mineo TC. Feasibility and results of awake thoracoscopic resection of solitary pulmonary nodules. Ann Thorac Surg. 2004 Nov;78(5):1761-8. doi: 10.1016/j.athoracsur.2004.05.083.
PubMed 15511470
Pompeo E. State of the art and perspectives in non-intubated thoracic surgery. Ann Transl Med. 2014 Nov;2(11):106. doi: 10.3978/j.issn.2305-5839.2014.10.01.
PubMed 25489580
Chiang XH, Lin MW. Converting to Intubation During Non-intubated Thoracic Surgery: Incidence, Indication, Technique, and Prevention. Front Surg. 2021 Oct 26;8:769850. doi: 10.3389/fsurg.2021.769850. eCollection 2021.
PubMed 34765639
Lohser J, Slinger P. Lung Injury After One-Lung Ventilation: A Review of the Pathophysiologic Mechanisms Affecting the Ventilated and the Collapsed Lung. Anesth Analg. 2015 Aug;121(2):302-18. doi: 10.1213/ANE.0000000000000808.
PubMed 26197368
Hung WT, Hung MH, Wang ML, Cheng YJ, Hsu HH, Chen JS. Nonintubated Thoracoscopic Surgery for Lung Tumor: Seven Years' Experience With 1,025 Patients. Ann Thorac Surg. 2019 Jun;107(6):1607-1612. doi: 10.1016/j.athoracsur.2019.01.013. Epub 2019 Feb 11.
PubMed 30763562
Gelzinis TA, Sullivan EA. Non-Intubated General Anesthesia for Video-Assisted Thoracoscopic Surgery. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):407-408. doi: 10.1053/j.jvca.2016.12.027. Epub 2016 Dec 23. No abstract available.
PubMed 28320572
Janik M, Juhos P, Lucenic M, Tarabova K. Non-intubated Thoracoscopic Surgery-Pros and Cons. Front Surg. 2021 Dec 6;8:801718. doi: 10.3389/fsurg.2021.801718. eCollection 2021.
PubMed 34938770
Liu J, Cui F, He J. Non-intubated video-assisted thoracoscopic surgery anatomical resections: a new perspective for treatment of lung cancer. Ann Transl Med. 2015 May;3(8):102. doi: 10.3978/j.issn.2305-5839.2015.04.18.
PubMed 26046043

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison Between Spontaneous Breathing-preserving Anesthesia and Double-lumen Endotracheal Intubation Anesthesia in Early-stage Non-small Cell Lung Cancer With a Diameter of ≤ 3 cm: a Prospective, Multicenter Randomized Controlled Study
ClinicalTrials.gov ID: NCT07327736
Acronym / sponsor ID: IIT202508-17-KYB-15-XWK
Conditions: Patients With Suspected Non-small Cell Lung Cancer (NSCLC) at Clinical Stage T1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 410 participants (estimated)
Lead sponsor: Tang-Du HospitalUniversity, hospital or other
Study start: 15 Mar 2026 (estimated)
Primary completion: 30 Jun 2028 (estimated)
Study completion: 31 Dec 2032 (estimated)
First posted: 8 Jan 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
group A	Experimental	Procedure: Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)
group B	Placebo comparator	Procedure: Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)Tracheal Intubation with One-Lung Ventilation Group (OLV)

Who may qualify

Ages: Up to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Age ≤ 75 years;
Gender is not limited;
Patients with suspected T1 stage non-small cell lung cancer (NSCLC) in preoperative clinical staging, with thin-slice CT showing that the maximum tumor diameter is ≤ 3.0 cm, single or multiple nodules, and the nodules requiring surgical resection are located in the same ipsilateral lung lobe, with the number of nodules resected simultaneously ≤ 3;
American Society of Anesthesiologists (ASA) classification ≤ Grade III (preferably Grade I - II is recommended);
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1;

Key exclusion criteria (9 listed)

A history of ipsilateral lung surgery;
Interstitial pneumonia, pulmonary fibrosis, severe emphysema, severe chronic obstructive pulmonary disease, acute phase of pulmonary infection, or uncontrolled asthma;
Sleep apnea syndrome with anticipated airway difficulty or difficulty in airway management;
Preoperative complications including coagulation dysfunction, hypoxemia, hypercapnia, or hepatic/renal insufficiency;
Alteration of anesthesia or surgical plan;

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 video-assisted thoracic surgery with spontaneous breathing (NIVATS)NIVATS is a special method developed in the past two decades. It means that patients do not undergo tracheal intubation under general anesthesia during the entire surgical process, retaining their spontaneous breathing, but supraglottic airway devices (such as laryngeal masks, high-flow nasal catheters, mask ventilation) can be used to support their breathing. The purpose of this technology is to minimize the impact of general anesthesia, tracheal intubation, mechanical ventilation, etc. on patients.	Procedure or surgery	group A, group B

Primary outcome

Average postoperative hospital stay
Time frame: up to 3 months
Intraoperative opioid consumption
Time frame: 1 day

10 secondary outcomes

Lung collapse score
Time frame: 1 day
Intraoperative blood gas analysis (Q1h)
Time frame: 1 day
Conversion to intubation rate
Time frame: 1 day
Postoperative awakening time
Time frame: 1 day
Time to first ambulation after surgery
Time frame: up to 3 months
Ambulation rate within 4 hours after surgery
Time frame: up to 3 months
Inflammatory markers (IL-6, peripheral neutrophil-to-lymphocyte ratio)
Time frame: up to 3 months
Postoperative drainage volume
Time frame: up to 3 months
Incidence of perioperative complications
Time frame: up to 3 months
15 item Quality of Recovery Rating Scale (QoR-15)
Time frame: up to 1 year

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 12 Mar 2026.
Background: PubMed 15511470Pompeo E, Mineo D, Rogliani P, Sabato AF, Mineo TC. Feasibility and results of awake thoracoscopic resection of solitary pulmonary nodules. Ann Thorac Surg. 2004 Nov;78(5):1761-8. doi: 10.1016/j.athoracsur.2004.05.083.
Background: PubMed 25489580Pompeo E. State of the art and perspectives in non-intubated thoracic surgery. Ann Transl Med. 2014 Nov;2(11):106. doi: 10.3978/j.issn.2305-5839.2014.10.01.
Background: PubMed 34765639Chiang XH, Lin MW. Converting to Intubation During Non-intubated Thoracic Surgery: Incidence, Indication, Technique, and Prevention. Front Surg. 2021 Oct 26;8:769850. doi: 10.3389/fsurg.2021.769850. eCollection 2021.
Background: PubMed 26197368Lohser J, Slinger P. Lung Injury After One-Lung Ventilation: A Review of the Pathophysiologic Mechanisms Affecting the Ventilated and the Collapsed Lung. Anesth Analg. 2015 Aug;121(2):302-18. doi: 10.1213/ANE.0000000000000808.
Background: PubMed 30763562Hung WT, Hung MH, Wang ML, Cheng YJ, Hsu HH, Chen JS. Nonintubated Thoracoscopic Surgery for Lung Tumor: Seven Years' Experience With 1,025 Patients. Ann Thorac Surg. 2019 Jun;107(6):1607-1612. doi: 10.1016/j.athoracsur.2019.01.013. Epub 2019 Feb 11.
Background: PubMed 28320572Gelzinis TA, Sullivan EA. Non-Intubated General Anesthesia for Video-Assisted Thoracoscopic Surgery. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):407-408. doi: 10.1053/j.jvca.2016.12.027. Epub 2016 Dec 23. No abstract available.
Background: PubMed 34938770Janik M, Juhos P, Lucenic M, Tarabova K. Non-intubated Thoracoscopic Surgery-Pros and Cons. Front Surg. 2021 Dec 6;8:801718. doi: 10.3389/fsurg.2021.801718. eCollection 2021.
Background: PubMed 26046043Liu J, Cui F, He J. Non-intubated video-assisted thoracoscopic surgery anatomical resections: a new perspective for treatment of lung cancer. Ann Transl Med. 2015 May;3(8):102. doi: 10.3978/j.issn.2305-5839.2015.04.18.
Individual participant dataSharing planned: No

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.

Xiaolong Yan, Doctor of Medicine (M.D.) contact

+8615991269383

yanxiaolong@fmmu.edu.cn

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 9 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: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Xiaolong Yan, Doctor of Medicine (M.D.) (+8615991269383, yanxiaolong@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average postoperative hospital stay (time frame: up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07327736, which also lists 8 linked publications.

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 12 Mar 2026.