Clinical trial NCT06574295: HTA of NIVATS Based on RWE
Official title: Health Technology Assessment of Pulmonary Nodules Using Non-intubated Video-assisted Thoracic Surgery Based on the Real-world Evidence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: Lung cancer; Pulmonary nodule; VATs
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


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.

Primary outcomes:
measure: Patient-reported Outcomes
timeFrame: Measured within 3 days post-surgery
measure: Postoperative hospitalization time
timeFrame: Measured in days from surgery completion to hospital discharge.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: School of Public Health, Fudan University
state: Shanghai
Study officials:
affiliation: School of Public Health，Fudan University
name: Yingyao Chen, PhD
role: STUDY_CHAIR
References: