An observational study in Lung Cancer, sponsored by Fudan University. Completed at 21 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Fudan University · Observational
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 876 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
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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.
- Experimental Group (Non-intubated Video-assisted Thoracic Surgery)：
Control Group (Intubated Video-assisted Thoracic Surgery)：
Exclusion Criteria:
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.
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.
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.
Time frame: 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.
Time frame: Measured in days from surgery completion to hospital discharge.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Fudan University