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.
Chronic obstructive pulmonary disease (COPD) is a common respiratory disease, affecting nearly 100 million people in China, with the highest mortality rate globally. It is strongly associated with lung cancer, as both share risk factors such as tobacco exposure and environmental pollution. Additionally, chronic inflammation and abnormal repair mechanisms in COPD further increase the risk of lung cancer. Early diagnosis and treatment of lung cancer are crucial, particularly in detecting pulmonary nodules (GGN). Although malignant GGNs progress slowly, early surgical resection remains the best curative option. However, COPD patients face high surgical risks and should carefully consider their treatment options. Microwave ablation (MWA) has been widely used as a local treatment for early-stage lung cancer, showing similar efficacy to surgery. However, percutaneous procedures may lead to complications such as pneumothorax and bleeding. In contrast, bronchoscopic thermal vapor ablation (BTVA), performed under general anesthesia, avoids the drawbacks of local anesthesia, enables precise tumor ablation, and improves lung function. Studies suggest that BTVA holds great promise for the treatment of both COPD and lung cancer, offering a new therapeutic option. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
The eligible subjects will be stratified according to stratification factors (pure GGN/mixed GGN, lesion size ≤1cm/\>1cm, FEV1 ≤50%/\>50%) and randomized at a 1:1 ratio to two groups. Patients in the BTVA group will undergo BTVA treatment.
The eligible subjects will be stratified according to stratification factors (pure GGN/mixed GGN, lesion size ≤1cm/\>1cm, FEV1 ≤50%/\>50%) and randomized at a 1:1 ratio to two groups. Patients in the MWA group will undergo MWA treatment.
Complete ablation rate at 12 months postoperatively
Time frame: 12 months postoperatively
Technical implementation success rate
Time frame: On the day of surgery
Complete ablation rate at 6 months postoperatively
Time frame: 6 months postoperatively
Changes in pulmonary function indicators(FEV1) at 6 months, 12 months, and 24 months post-treatment compared to baseline
Time frame: 6,12 and 24 months postoperatively
Changes in lung volume assessed by HRCT at 6 months, 12 months, and 24 months post-treatment compared to baseline
Time frame: 6,12 and 24 months postoperatively
Improvement in exercise tolerance at 6 months, 12 months, and 24 months post-treatment compared to baseline: 6MWD
Time frame: 6,12 and 24 months postoperatively
Improvement in symptom score(mMRC) at 6 months, 12 months, and 24 months post-treatment compared to baseline
Time frame: 6,12 and 24 months postoperatively
Local control rates at 1 year, 2 years, and 3 years postoperatively
Time frame: 1 year, 2 years, and 3 years postoperatively
Progression-free survival (PFS)
Time frame: 1 year, 2 years, and 3 years postoperatively
Overall survival (OS)
Time frame: 1 year, 2 years, and 3 years postoperatively
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TREATMENT
Masking
NONE
Enrollment
26
Safety:Evaluate the incidence of (serious) adverse events
Evaluate the incidence of (serious) adverse events related to the device or procedure during the study period.
Time frame: On the day of surgery