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NCT Number: NCT06574295

HTA of NIVATS Based on RWE

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.

Recruiting

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Public Health, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Yingyao Chen, PhD

CONTACT

[email protected]

8613564508981

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Experimental Group (Non-intubated Video-assisted Thoracic Surgery)：

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

Control Group (Intubated Video-assisted Thoracic Surgery)：

Patients diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery (including wedge resection, segmentectomy, or lobectomy).
Aged between 18 and 75 years, regardless of gender.
Preoperative assessment indicates that the patient can tolerate minimally invasive surgery.
The patient has signed an informed consent form and voluntarily agrees to participate in the study.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Patient-reported Outcomes

Time frame: 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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yingyao Chen, PhD

CONTACT

[email protected]

8613564508981

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Aug 27, 2024
Registry last updated: Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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