Lung CancerNCT06574295
HTA of NIVATS Based on RWE
An observational study of Lung Cancer, run by Fudan University at 21 sites in China.
Trial summary
This research focuses on a Health Technology Assessment (HTA) of non-intubated video-assisted thoracic surgery (VATS) for lung nodules. Lung cancer, one of the most prevalent malignancies globally, has a high incidence and mortality rate, particularly in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- How many people
- 876 participants
- Where
- 21 sitesChina
- Study dates
- 20 Aug 2024to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 to 75 years who have been diagnosed with pulmonary nodules or lung cancer and are scheduled for minimally invasive thoracic surgery. These patients will be divided into two groups: an experimental group undergoing non-intubated video-assisted thoracic surgery (VATS) and a control group undergoing intubated VATS. Both groups include individuals who are able to tolerate surgery based on preoperative evaluations, regardless of gender. All participants must provide informed consent and agree to complete the required follow-up assessments.
Who may be able to join
- Experimental Group (Non-intubated Video-assisted Thoracic Surgery)：
- Patients diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery (including wedge resection, segmentectomy, or lobectomy).
- Aged between 18 and 75 years, regardless of gender.
- Preoperative assessment indicates that the patient can tolerate non-intubated video-assisted thoracic surgery.
- The patient has signed an informed consent form and voluntarily agrees to participate in the study.
- Control Group (Intubated Video-assisted Thoracic Surgery)：
Show all 10Show fewer
- Patients diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery (including wedge resection, segmentectomy, or lobectomy).
- Aged between 18 and 75 years, regardless of gender.
- Preoperative assessment indicates that the patient can tolerate minimally invasive surgery.
- The patient has signed an informed consent form and voluntarily agrees to participate in the study.
Who cannot join
- Patients unable to provide sufficient preoperative and postoperative follow-up data.
- Pregnant or breastfeeding women.
- Patients with severe cardiopulmonary dysfunction preoperatively, making them unfit for surgery.
- Patients who have previously undergone surgery or radiotherapy in the same chest region.
- Patients with active infections or other severe comorbidities that may affect surgical outcomes.
- Patients with mental illness or cognitive impairment who cannot understand the study content or comply with follow-up requirements.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites
Anning First People's Hospital
Anning, Yunnan, 650300
Anyang Tumor Hospital
Anyang, Henan, 455001
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
Binzhou Medical University Hospital
Binzhou, Shandong, 256603
Cangzhou Central Hospital
Cangzhou, Hebei, 061001
Chongqing General Hospital
Chongqing, Chongqing Municipality, 401147
Deyang People's Hospital
Deyang, Sichuan, 618000
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Guangxi Zhuang Autonomous Region Nanxishan Hospital
Guilin, Guangxi, 541002
Anhui Chest Hospital
Hefei, Anhui, 230022
The Second Affiliated Hospital of University of South China
Hengyang, Hunan, 421001
The Second Hospital of Shandong University
Jinan, Shandong, 250033
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
School of Public Health, Fudan University
Shanghai, Shanghai Municipality, 200032
Shaoxing People's Hospital
Shaoxing, Zhejiang, 312000
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Wuhan Central Hospital
Wuhan, Hubei, 430014
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Health Technology Assessment of Pulmonary Nodules Using Non-intubated Video-assisted Thoracic Surgery Based on the Real-world Evidence
This research focuses on a Health Technology Assessment (HTA) of non-intubated video-assisted thoracic surgery (VATS) for lung nodules. Lung cancer, one of the most prevalent malignancies globally, has a high incidence and mortality rate, particularly in China. Traditional treatments like thoracotomy are highly invasive, while conventional thoracoscopic surgery can induce anesthesia-related complications. Non-intubated VATS offers a promising alternative by avoiding intubation and mechanical ventilation, thus reducing complications, anesthesia burden, and recovery time.
The study aims to comprehensively assess the clinical effectiveness, safety, and economic viability of non-intubated VATS for lung cancer treatment through systematic literature reviews, real-world evidence (RWE), and cost-effectiveness analysis. The research will also explore patient preferences using discrete choice experiments (DCE).
By evaluating this technology from a Chinese perspective, the study seeks to provide evidence-based recommendations for the broader adoption of non-intubated VATS in clinical settings.
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Pulmonary nodule, VATs, NIVATs
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-intubated Video-assisted Thoracic Surgery Group | This group will undergo non-intubated video-assisted thoracic surgery (VATS), a minimally invasive procedure that avoids the use of endotracheal intubation and mechanical ventilation. Instead, patients maintain spontaneous breathing throughout the surgery under regional anesthesia or sedation. The technique is designed to reduce anesthesia-related complications, improve recovery times, and enhance overall patient comfort compared to traditional intubated thoracic surgeries. | |
| Intubated Thoracic Surgery Group | This group will undergo traditional intubated thoracic surgery, where patients are intubated and placed on mechanical ventilation under general anesthesia. This method is commonly used in thoracic surgeries to control the airway and ensure adequate ventilation during the procedure. However, it may be associated with a higher incidence of anesthesia-related complications, such as airway trauma and slower postoperative recovery, compared to non-intubated techniques. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported Outcomes
The primary outcome will be assessed using two validated instruments: MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) and the EQ-5D-5L questionnaire. The Anderson Symptom Inventory will measure symptom severity (e.g., pain, fatigue, nausea, sleep disturbance) and the impact of symptoms on daily functioning, while the EQ-5D will evaluate overall health-related quality of life, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores will provide insight into patients' recovery and well-being following non-intubated video-assisted thoracic surgery (VATS) compared to traditional intubated thoracic surgery.
Measured: Measured within 3 days post-surgery
Postoperative hospitalization time
The secondary outcome will measure the duration of the postoperative hospital stay. This will be assessed as the number of days from the completion of surgery to the patient's discharge. The goal is to compare the efficiency of recovery between patients undergoing non-intubated video-assisted thoracic surgery (VATS) and those receiving traditional intubated thoracic surgery.
Measured: Measured in days from surgery completion to hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start20 Aug 2024
- Primary completion24 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 876 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingyao Chen, Fudan University
- Investigators
- Yingyao Chen, PhD, Study chair, School of Public Health，Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574295
- Sponsor's protocol ID
- FudanU-2024-07-1145
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Technology Assessment of Pulmonary Nodules Using Non-intubated Video-assisted Thoracic Surgery Based on the Real-world Evidence
- ClinicalTrials.gov ID
- NCT06574295
- Acronym / sponsor ID
- FudanU-2024-07-1145
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Pulmonary nodule, VATs, NIVATs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 876 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 27 Aug 2024 (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.
This research focuses on a Health Technology Assessment (HTA) of non-intubated video-assisted thoracic surgery (VATS) for lung nodules. Lung cancer, one of the most prevalent malignancies globally, has a high incidence and mortality rate, particularly in China. Traditional treatments like thoracotomy are highly invasive, while conventional thoracoscopic surgery can induce anesthesia-related complications. Non-intubated VATS offers a promising alternative by avoiding intubation and mechanical ventilation, thus reducing complications, anesthesia burden, and recovery time.
The study aims to comprehensively assess the clinical effectiveness, safety, and economic viability of non-intubated VATS for lung cancer treatment through systematic literature reviews, real-world evidence (RWE), and cost-effectiveness analysis. The research will also explore patient preferences using discrete choice experiments (DCE).
By evaluating this technology from a Chinese perspective, the study seeks to provide evidence-based recommendations for the broader adoption of non-intubated VATS in clinical settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-intubated Video-assisted Thoracic Surgery Group | – | –This group will undergo non-intubated video-assisted thoracic surgery (VATS), a minimally invasive procedure that avoids the use of endotracheal intubation and mechanical ventilation. Instead, patients maintain spontaneous breathing throughout the surgery under regional anesthesia or sedation. The technique is designed to reduce anesthesia-related complications, improve recovery times, and enhance overall patient comfort compared to traditional intubated thoracic surgeries. |
| Intubated Thoracic Surgery Group | – | –This group will undergo traditional intubated thoracic surgery, where patients are intubated and placed on mechanical ventilation under general anesthesia. This method is commonly used in thoracic surgeries to control the airway and ensure adequate ventilation during the procedure. However, it may be associated with a higher incidence of anesthesia-related complications, such as airway trauma and slower postoperative recovery, compared to non-intubated techniques. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 to 75 years who have been diagnosed with pulmonary nodules or lung cancer and are scheduled for minimally invasive thoracic surgery. These patients will be divided into two groups: an experimental group undergoing non-intubated video-assisted thoracic surgery (VATS) and a control group undergoing intubated VATS. Both groups include individuals who are able to tolerate surgery based on preoperative evaluations, regardless of gender. All participants must provide informed consent and agree to complete the required follow-up assessments.
Key inclusion criteria (10 listed)
- Experimental Group (Non-intubated Video-assisted Thoracic Surgery)：
- Patients diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery (including wedge resection, segmentectomy, or lobectomy).
- Aged between 18 and 75 years, regardless of gender.
- Preoperative assessment indicates that the patient can tolerate non-intubated video-assisted thoracic surgery.
- The patient has signed an informed consent form and voluntarily agrees to participate in the study.
Key exclusion criteria (6 listed)
- Patients unable to provide sufficient preoperative and postoperative follow-up data.
- Pregnant or breastfeeding women.
- Patients with severe cardiopulmonary dysfunction preoperatively, making them unfit for surgery.
- Patients who have previously undergone surgery or radiotherapy in the same chest region.
- Patients with active infections or other severe comorbidities that may affect surgical outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient-reported Outcomes
Time frame: Measured within 3 days post-surgery
The primary outcome will be assessed using two validated instruments: MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) and the EQ-5D-5L questionnaire. The Anderson Symptom Inventory will measure symptom severity (e.g., pain, fatigue, nausea, sleep disturbance) and the impact of symptoms on daily functioning, while the EQ-5D will evaluate overall health-related quality of life, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores will provide insight into patients' recovery and well-being following non-intubated video-assisted thoracic surgery (VATS) compared to traditional intubated thoracic surgery.
Postoperative hospitalization time
Time frame: Measured in days from surgery completion to hospital discharge.
The secondary outcome will measure the duration of the postoperative hospital stay. This will be assessed as the number of days from the completion of surgery to the patient's discharge. The goal is to compare the efficiency of recovery between patients undergoing non-intubated video-assisted thoracic surgery (VATS) and those receiving traditional intubated thoracic surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Yingyao Chen, PhD study chair
School of Public Health，Fudan University
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Fudan University at 21 sites 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported Outcomes (time frame: Measured within 3 days post-surgery). 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?
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 8 Sep 2026.