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HTA of NIVATS Based on RWE

Health Technology Assessment of Pulmonary Nodules Using Non-intubated Video-assisted Thoracic Surgery Based on the Real-world Evidence

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06574295
Enrollment
876
Registered
2024-08-27
Start date
2024-08-20
Completion date
2025-01-30
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Lung cancer, Pulmonary nodule, VATs, NIVATs

Brief 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. 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.

Interventions

None listed

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

\- Experimental Group (Non-intubated Video-assisted Thoracic Surgery): 1. Patients diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery (including wedge resection, segmentectomy, or lobectomy). 2. Aged between 18 and 75 years, regardless of gender. 3. Preoperative assessment indicates that the patient can tolerate non-intubated video-assisted thoracic surgery. 4. The patient has signed an informed consent form and voluntarily agrees to participate in the study. Control Group (Intubated Video-assisted Thoracic Surgery): 1. Patients diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery (including wedge resection, segmentectomy, or lobectomy). 2. Aged between 18 and 75 years, regardless of gender. 3. Preoperative assessment indicates that the patient can tolerate minimally invasive surgery. 4. The patient has signed an informed consent form and voluntarily agrees to participate in the study.

Exclusion criteria

1. Patients unable to provide sufficient preoperative and postoperative follow-up data. 2. Pregnant or breastfeeding women. 3. Patients with severe cardiopulmonary dysfunction preoperatively, making them unfit for surgery. 4. Patients who have previously undergone surgery or radiotherapy in the same chest region. 5. Patients with active infections or other severe comorbidities that may affect surgical outcomes. 6. Patients with mental illness or cognitive impairment who cannot understand the study content or comply with follow-up requirements.

Design outcomes

Primary

MeasureTime frameDescription
Patient-reported OutcomesMeasured within 3 days post-surgeryThe 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 timeMeasured 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.

Countries

China

Contacts

STUDY_CHAIRYingyao Chen, PhD

School of Public Health,Fudan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026