Comparing BTVA and MWA in COPD With Early Lung Cancer: Efficacy and Safety

Korábbi kezelés

• Respiratory tract infection or acute exacerbation of chronic obstructive pulmonary disease within the preceding 6 weeks before screening;
• Discontinuation of anticoagulant and/or antiplatelet medications (excluding new oral anticoagulants such as dabigatran, rivaroxaban) for less than 5-7 days before surgery;

Más betegség

• Subjects meeting any of the following conditions are ineligible for inclusion:
• Tumor located within 2cm of the trachea, main bronchi, esophagus, aortic arch branches, main pulmonary artery, left and right pulmonary arteries, or heart, and within 1cm of the nearest pleural boundary;
• Coexisting conditions or medication use increasing the risk of post-treatment complications, including but not limited to: autoimmune disorders, clinically significant immunosuppressants, history of asthma, α-1 antitrypsin deficiency;
• History of cardiac or pulmonary transplantation, surgical lung volume reduction, median sternotomy, endoscopic lung volume reduction (e.g., valves, coils), lobectomy, or lung resection;
• Other conditions deemed unsuitable for participation by the investigator.

Laborértékek

• 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
• Active pathogenic infection or evidence of active infection (e.g., fever, elevated white cell count), poorly controlled infectious or inflammatory conditions around the lesion or at the puncture site;

Egyéb

• Pulmonary function reports indicating FEV1 ≤ 20% predicted value, or DLCO ≤ 20%;
• 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;
• High-density emphysematous changes simultaneously present in the upper and lower lobes of the contralateral lung, defined as HRCT showing low attenuation areas (<-950 HU) comprising more than 40% of the total lung volume;
• Daily prednisolone intake exceeding 10mg or an equivalent dose of glucocorticoids during the screening visit;
• Eastern Cooperative Oncology Group (ECOG) score >2;
• Participation in or currently involved in other clinical studies within the past 30 days;

• Subjects meeting all of the following criteria are eligible for inclusion:
• 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