Lung nodule
Conditions
Interventions
Experimental Group:Transbronchial biopsy combined with cryoablation for pulmonary nodules under ICNVA-RAB guidance
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years; 2.Single target pulmonary lesion located in the peripheral lung field, with maximum diameter <=2 cm and CTR <=0.25; 3.Preoperative imaging highly suspicious for primary non-small cell lung cancer (NSCLC), and assessed by the research team as suitable for robot-assisted bronchoscopic diagnostic and therapeutic integrated procedure; 4.Subject refuses surgical intervention, or comprehensive evaluation by thoracic surgery and anesthesiology teams indicates high surgical risk and unsuitability for surgical treatment; 5.ECOG performance status score <=3; 6.Able to understand the study objectives, risks, and alternative treatment options, and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Presence of definite distant metastasis, highly suspected mediastinal or hilar lymph node metastasis unsuitable for local treatment; 2.Target nodule located <5 mm from the main pulmonary artery, aortic arch, esophagus, or pericardium, with assessment indicating unacceptable risk for transbronchial cryoablation; 3.Uncorrectable coagulopathy, active bleeding, severe anemia, or inability to discontinue anticoagulant/antiplatelet medications as required before surgery; 4.Severe respiratory failure, severe pulmonary hypertension, decompensated heart failure, active infection, or other conditions judged by the investigator as unsuitable for general anesthesia and bronchoscopic procedures; 5.Pregnancy, lactation, or definite pregnancy plans during the study period; 6.Participation in other interventional clinical trials within the past 30 days; 7.Any other condition deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete ablation rate at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Quality of Life;6-month intrapulmonary progression-free survival rate;Complete ablation rate at 12 months;Adverse event rate;12-month intrapulmonary progression-free survival rate;12-month overall survival rate (OS); | — |
Countries
China
Contacts
Public ContactShaohua Dai
The First Affiliated Hospital of Nanchang University
Outcome results
None listed