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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

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
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100927
Enrollment
Unknown
Registered
2025-04-17
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease with early-stage lung cancer

Interventions

Micorwave ablation group:Micorwave ablation
Bronchoscopic thermal vapor ablation group:Bronchoscopic thermal vapor ablation

Sponsors

Henan Provincial People's Hospita,medical
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)Patients aged 35-80 years, regardless of gender, meeting diagnostic criteria for chronic obstructive pulmonary disease (COPD). 2)Presence of ground-glass nodules (GGNs) on chest CT with a solid-to-tumor ratio (CTR) <=0.25. 3)Nodule size <2 cm, located in the upper lobes of both lungs. 4)Pathologically confirmed primary peripheral lung cancer with preoperative staging evaluation indicating clinical stage T1a or T1b N0 M0. 5)Lesion accessibility confirmed for both transbronchial and percutaneous ablation approaches by investigator assessment. 6)Patients deemed ineligible for surgery, declining surgical intervention, or unwilling/intolerant to undergo radiotherapy/chemotherapy. 7)Written informed consent obtained with demonstrated comprehension and commitment to follow-up protocols.

Exclusion criteria

Exclusion criteria: 1)Contraindications to bronchoscopy, including: a) Myocardial infarction or unstable myocardial ischemia within 1 month prior, with left ventricular ejection fraction (EF) 1/3 of the target lung lobe/subsegment or presence of paraseptal emphysema in the target area; 5)Coexisting severe emphysema in both upper and lower contralateral lung lobes, defined as low-attenuation areas (LAAs =5-7 days pre-procedure; 9)Comorbidities/medications increasing complication risks, including: Immunological disorders, Clinically significant immunosuppressant use, Asthma history, a-1 antitrypsin deficiency; 10)Daily prednisolone intake >10 mg (or equivalent glucocorticoid dosage) during screening; 11)Prior thoracic interventions: Lung/heart transplantation,Surgical lung volume reduction,Median sternotomy,Endoscopic lung reduction (valves/coils) ,Bullectomy/lobectomy; 12)Eastern Cooperative Oncology Group (ECOG) performance status >2; 13)Participation in other clinical trials within 30 days prior to enrollment; 14)Other investigator-determined contraindications for trial participation;

Design outcomes

Primary

MeasureTime frame
Complete Ablation Rate at 12 Months Post-Procedure;

Secondary

MeasureTime frame
CAT?mMRC;Incidence of Adverse Events;Technical Success Rate;FEV1?FVC?RV?TLC?RV/TLC?DLCO;Progression-free survival;Local Control Rate;

Countries

China

Contacts

Public ContactXiaoju Zhang

Henan Provincial People's Hospita,medical

15837101166@163.com+86 371 87160159

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026