Assessment of non-intubated video-assisted thoracic surgery for lung cancer

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

This study is testing a new type of lung surgery that doesn't require putting a tube in the throat to see if it is safer, works better, and costs less for people with lung cancer.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06574295 on ClinicalTrials.gov

What this trial studies

This research evaluates the effectiveness, safety, and economic viability of non-intubated video-assisted thoracic surgery (VATS) for treating lung cancer and pulmonary nodules. By utilizing real-world evidence and systematic literature reviews, the study aims to compare non-intubated VATS with traditional intubated approaches, focusing on patient outcomes and preferences. The research will also conduct cost-effectiveness analyses to determine the financial implications of adopting this less invasive surgical technique. The study is particularly relevant in the context of high lung cancer incidence rates in China.

Who should consider this trial

Good fit: Ideal candidates include patients aged 18 to 75 diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery.

Not a fit: Patients who are not candidates for minimally invasive surgery or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to reduced complications and faster recovery times for lung cancer patients undergoing surgery.

How similar studies have performed: While non-intubated VATS is a relatively novel approach, preliminary studies have shown promising results, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• School of Public Health, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yingyao Chen, PhD

Conditions Lung Cancer; Lung cancer; Pulmonary nodule; VATs