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Not yet recruitingNCT06929390Updated Apr 18, 2025

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

An interventional study of BTVA and MWA in Copd and Lung Cancer, sponsored by Henan Provincial People's Hospital. Not yet recruiting. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-18.

Sponsored by Henan Provincial People's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
35 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Copd
  • Lung Cancer

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 26 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Henan Provincial People's Hospital is the lead sponsor of 63 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    bronchoscopic thermal vapor ablation

    Patients will undergo bronchoscopically guided thermal vapor ablation therapy

    Procedure: BTVA

  • Experimental
    percutaneous microwave ablation

    Patients will undergo CT-guided percutaneous microwave ablation therapy

    Procedure: MWA

Interventions

  • ProcedureBTVA

    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.

  • ProcedureMWA

    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.

06

What researchers measure

Primary outcomes

  1. Complete ablation rate at 12 months postoperatively

    Time frame: 12 months postoperatively

Secondary outcomes

  1. Technical implementation success rate

    Time frame: On the day of surgery

  2. Complete ablation rate at 6 months postoperatively

    Time frame: 6 months postoperatively

  3. 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

  4. 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

  5. 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

  6. 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

  7. Local control rates at 1 year, 2 years, and 3 years postoperatively

    Time frame: 1 year, 2 years, and 3 years postoperatively

  8. Progression-free survival (PFS)

    Time frame: 1 year, 2 years, and 3 years postoperatively

  9. Overall survival (OS)

    Time frame: 1 year, 2 years, and 3 years postoperatively

  10. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06929390
Lead sponsor
Henan Provincial People's Hospital
Responsible party
Sponsor
First posted
Apr 16, 2025
Start date
May 1, 2025 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 18, 2025

Study contacts

Quncheng Zhang, Master
Contact
zhangqc@zzu.edu.cn
15038142486

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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