Comparing BTVA and MWA in COPD With Early Lung Cancer: Efficacy and Safety (NCT06929390) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparing BTVA and MWA in COPD With Early Lung Cancer: Efficacy and Safety
26 participantsStarted 2025-05-01
Plain-language summary
Based on the advantages of BTVA in the treatment of early-stage lung cancer and COPD, researchers propose the concept of using BTVA to treat COPD combined with early-stage lung cancer. Researchers plan to conduct a multicenter clinical study focusing on patients with COPD combined with malignant GGNs. Bronchoscopic BTVA surgery or percutaneous MWA surgery will be performed, evaluating the effectiveness and safety of bronchoscopic BTVA and percutaneous MWA surgery in the treatment of COPD combined with early-stage lung cancer.
Who can participate
Age range35 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients of any gender aged between 35 and 80 years with a diagnosis of chronic obstructive pulmonary disease (COPD);
✓. Chest CT showing ground-glass nodules (GGNs) with a solid/tumor ratio (CTR) ≤ 0.25;
✓. Nodule size \< 2cm located in the upper lobes of both lungs;
✓. Pathologically diagnosed as primary peripheral lung cancer, with preoperative clinical staging indicating T1a, bN0M0;
✓. Investigator assessment that ablative techniques can be feasibly implemented via bronchoscopic or percutaneous approaches to reach the lesion;
✓. Patients unable to undergo surgery or refuse surgery and are unwilling or intolerant to radiation or chemotherapy;
✓. Signing an informed consent form, understanding, and actively cooperating with follow-up procedures
Exclusion criteria
✕. Bronchoscopy contraindications, such as:
✕. Myocardial infarction within the past month, unstable myocardial ischemia, ejection fraction (EF) ≤40%
✕. Active hemoptysis
✕. Coagulation disorders
✕. Severe hepatic, renal, cardiac, pulmonary, or cerebral dysfunction, severe anemia, dehydration, and severe nutritional disturbances that cannot be corrected or improved in the short term
What they're measuring
1
Complete ablation rate at 12 months postoperatively
✕. Pulmonary function reports indicating FEV1 ≤ 20% predicted value, or DLCO ≤ 20%;
✕. Respiratory tract infection or acute exacerbation of chronic obstructive pulmonary disease within the preceding 6 weeks before screening;
✕. Presence of large bullae in the lobe containing the target lung segment/subsegment (defined as bullae occupying more than 1/3 of the lobe) or paraseptal emphysema;