HTA of NIVATS Based on RWE

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06574295
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-20
• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27
• Primary Completion: 2024-12-30
• Study Completion: 2025-03-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-reported Outcomes	Measured within 3 days post-surgery	The primary outcome will be assessed using two validated instruments: the Anderson Symptom Inventory (lung cancer-specific module) and the EQ-5D. 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	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.

Trial Locations

Locations (1)

School of Public Health, Fudan University; 🇨🇳 Shanghai, Shanghai, China