NCT06929390

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

A Prospective, Multicenter, Randomized Controlled Clinical Trial Comparing Bronchoscopic Thermal Vapor Ablation and Percutaneous Microwave Ablation in Patients With COPD and Early-Stage Lung Cancer: Efficacy and Safety Evaluation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Henan Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Copd
• Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	BTVA	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.
PROCEDURE	MWA	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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-04-16
• Last updated: 2025-04-18