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

Launched by HENAN PROVINCIAL PEOPLE'S HOSPITAL · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to compare two different treatments for patients who have both chronic obstructive pulmonary disease (COPD) and early-stage lung cancer. The study will evaluate the effectiveness and safety of two procedures: bronchoscopic BTVA (a type of surgery done through the airways) and percutaneous MWA (a minimally invasive technique done through the skin). Researchers aim to find out which method works better for treating patients who have small ground-glass nodules in their lungs, which may indicate early lung cancer.

To be eligible for this trial, participants need to be between the ages of 35 and 80 and have a diagnosis of COPD along with specific types of lung nodules. They should also be unable to undergo standard surgery or chemotherapy. If you participate, you can expect to undergo one of the two treatments and be closely monitored for safety and effectiveness. This study is not yet recruiting participants, but it represents an important step in finding better options for those facing these challenging health conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects meeting all of the following criteria are eligible for inclusion:
• • 1. Patients of any gender aged between 35 and 80 years with a diagnosis of chronic obstructive pulmonary disease (COPD);
• • 2. Chest CT showing ground-glass nodules (GGNs) with a solid/tumor ratio (CTR) ≤ 0.25;
• • 3. Nodule size \< 2cm located in the upper lobes of both lungs;
• • 4. Pathologically diagnosed as primary peripheral lung cancer, with preoperative clinical staging indicating T1a, bN0M0;
• • 5. Investigator assessment that ablative techniques can be feasibly implemented via bronchoscopic or percutaneous approaches to reach the lesion;
• • 6. Patients unable to undergo surgery or refuse surgery and are unwilling or intolerant to radiation or chemotherapy;
• • 7. Signing an informed consent form, understanding, and actively cooperating with follow-up procedures
• Exclusion Criteria:
• Subjects meeting any of the following conditions are ineligible for inclusion:
• 1. Bronchoscopy contraindications, such as:
• • 1. Myocardial infarction within the past month, unstable myocardial ischemia, ejection fraction (EF) ≤40%
• • 2. Active hemoptysis
• • 3. Coagulation disorders
• • 4. 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
• • 2. Pulmonary function reports indicating FEV1 ≤ 20% predicted value, or DLCO ≤ 20%;
• • 3. Respiratory tract infection or acute exacerbation of chronic obstructive pulmonary disease within the preceding 6 weeks before screening;
• • 4. 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;
• • 5. 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;
• • 6. 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;
• • 7. 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;
• • 8. Discontinuation of anticoagulant and/or antiplatelet medications (excluding new oral anticoagulants such as dabigatran, rivaroxaban) for less than 5-7 days before surgery;
• • 9. 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;
• • 10. Daily prednisolone intake exceeding 10mg or an equivalent dose of glucocorticoids during the screening visit;
• • 11. History of cardiac or pulmonary transplantation, surgical lung volume reduction, median sternotomy, endoscopic lung volume reduction (e.g., valves, coils), lobectomy, or lung resection;
• • 12. Eastern Cooperative Oncology Group (ECOG) score \>2;
• • 13. Participation in or currently involved in other clinical studies within the past 30 days;
• • 14. Other conditions deemed unsuitable for participation by the investigator.