Health TrialsbyHealthPanel

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

ConditionsCopdLung Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-80
SponsorHenan Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • BTVA

    Procedure/Surgery

    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.

  • MWA

    Procedure/Surgery

    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.

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: bronchoscopic thermal vapor ablationExperimental treatment 1 intervention
Group B: percutaneous microwave ablationExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henan Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: