HTA of NIVATS Based on RWE

NCT ID: NCT06574295

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-20
• Study Completion Date: 2025-03-02

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-intubated Video-assisted Thoracic Surgery Group

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.

No interventions assigned to this group

Intubated Thoracic Surgery Group

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Yingyao Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yingyao Chen, PhD

Role: STUDY_CHAIR

School of Public Health，Fudan University

Locations

School of Public Health, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yingyao Chen, PhD

Role: CONTACT

yychen@shmu.edu.cn

8613564508981

Facility Contacts

Yingyao Chen, PhD

Role: primary

yychen@shmu.edu.cn

8613564508981

Other Identifiers

FudanU-2024-07-1145

Identifier Type: -

Identifier Source: org_study_id