Pulmonary nodules in adults (nodule diameter =10mm)
Conditions
Interventions
Intervention group:Percutaneous puncture and spherical resection of the lung were performed using the pulmonary nodule spherical resection system for diagnosis and treatment
Control group:Diagnosis and treatment were carried out by thoracoscopic sublobectomy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 and <=80 years, both genders. 2. Meets the lung cancer screening diagnostic process according to the *Clinical Practice Guidelines for Lung Cancer Diagnosis and Treatment of the Chinese Medical Association (2025 Edition)*; after follow-up screening, malignancy cannot be excluded; and, as determined by the expert committee, has surgical indications and voluntarily agrees to undergo surgical treatment. 3. Has at least one pulmonary nodule <=10 mm in size; if it is a ground-glass nodule, its solid component ratio is <=25%; if it is a solid nodule, its maximum diameter is <=5 mm. 4. Able to understand the study objectives, voluntarily participates and signs the informed consent form, and is willing to complete the follow-up as required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with a distance of 16 seconds. 3. Patients with uncontrolled acute pleural infection within 2 weeks, or acute pulmonary infection requiring clinical treatment within 1 week, or other systemic infections currently under medical treatment. 4. Patients with obvious pulmonary bullae along the puncture route. 5. Patients with severe COPD and FEV1/FVC 8.0 mmol/L). 9. Patients with pleural peel formation. 10. Female patients who are pregnant or breastfeeding. 11. Patients who are mentally incapacitated, have severe mental illness, or are unable to understand the requirements for study participation and have difficulty cooperating. 12. Patients currently participating in other clinical trials of drugs or medical devices. 13. Patients with a history of allergy to anesthetic drugs used in surgery. 14. Patients with other conditions that, in the investigator's opinion, make them unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change rate of lung function (FEV1) at 180 days after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Negative margin rate;Complication rate;pain assessment;Disease-Free Survival;Device performance evaluation (only for the treatment group);intrapulmonary healing rate;Postoperative pulmonary function change rate;Radiation dose (only for the treatment group);Size of resected specimen;Duration of surgery;Success rate of surgery; | — |
Countries
China
Contacts
Public ContactLiu Lunxu
West China Hospital of Sichuan University
Outcome results
None listed