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

NCT06929390 | Not Yet Recruiting

• 1 other identifier: Xiaoju Zhang
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Copd; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Complete ablation rate at 12 months postoperatively

  12 months postoperatively

Secondary Outcomes (10)

• Technical implementation success rate

  On the day of surgery

• Complete ablation rate at 6 months postoperatively

  6 months postoperatively

• Changes in pulmonary function indicators（FEV1） at 6 months, 12 months, and 24 months post-treatment compared to baseline

  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

  6,12 and 24 months postoperatively

• Improvement in exercise tolerance at 6 months, 12 months, and 24 months post-treatment compared to baseline: 6MWD

  6,12 and 24 months postoperatively

Study Arms (2)

bronchoscopic thermal vapor ablation

EXPERIMENTAL

Patients will undergo bronchoscopically guided thermal vapor ablation therapy

Procedure: BTVA

percutaneous microwave ablation

EXPERIMENTAL

Patients will undergo CT-guided percutaneous microwave ablation therapy

Procedure: MWA

Interventions

BTVA PROCEDURE

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.

bronchoscopic thermal vapor ablation

MWA PROCEDURE

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.

percutaneous microwave ablation

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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;
• 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;
• 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;
• 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;
• Discontinuation of anticoagulant and/or antiplatelet medications (excluding new oral anticoagulants such as dabigatran, rivaroxaban) for less than 5-7 days before surgery;
• 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;
• Daily prednisolone intake exceeding 10mg or an equivalent dose of glucocorticoids during the screening visit;
• History of cardiac or pulmonary transplantation, surgical lung volume reduction, median sternotomy, endoscopic lung volume reduction (e.g., valves, coils), lobectomy, or lung resection;

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Quncheng Zhang, Master

CONTACT

15038142486; zhangqc@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: April 16, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share