本研究旨在通过将支气管镜消融置于与肺段切除及肺叶切除相同的实证框架内，以解决该领域的核心不足。研究将提供经调整的回溯性比较并利用人口数据进行外部验证、关于疾病控制与安全性的前瞻性非劣效性评估、关于肺功能与生活质量的定量证据，以及连结循环肿瘤DNA（c
适应症：Stage IA NSCLC
入组条件
纳入标准
- Adults aged ≥18 years
- Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm)
- Determined by multidisciplinary evaluation to be an appropriate candidate for bronchoscopic ablation as part of standard clinical care, and the patient agrees to a lung-preserving treatment approach
- Tumour size less than 2.5 cm in maximum diameter as measured on thin-slice chest CT
- Tumour located in the middle or peripheral third of the lung parenchyma
- Imaging and clinical evaluation indicate no lymph node involvement, and lymph node dissection for staging is not required
- Medically fit for bronchoscopic procedure under standard institutional anaesthesia protocols
- Pulmonary function results or clinical assessment indicate significant benefit from preserving lung tissue, such as predicted FEV1 or DLCO less than 40%, or clinician judgment that lung preservation is critical for quality of life
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adults aged ≥18 years
- Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm)
- Determined by multidisciplinary evaluation to have surgical resection as the preferred standard treatment option, and patient agrees to surgical resection.
- Tumour size between 2.5 and 3.0 cm, or smaller lesions for which surgery is considered the more appropriate option based on tumour features or safety concerns.
- Tumour located in the central third of the lung, or in proximity to heat-sensitive structures where surgery offers better oncologic and safety margins.
- Imaging findings suggest possible lymph node involvement or a clinical indication for systematic nodal dissection and pathological staging.
- Rapidly growing or high-SUV lesions on PET-CT requiring complete resection and full histologic staging.
- Medically fit for general anaesthesia and surgical resection, with capability for intraoperative frozen-section margin assessment
排除标准
- Presence of lymph node involvement (N1 or higher) or distant metastases (M1)
- Centrally located tumours within the inner third of the lung or those requiring ablation near major airways
- Tumours adjacent to heat-sensitive structures (e.g., main bronchi, oesophagus, pericardium, aorta, or pulmonary artery) where adequate ablation margins cannot be safely achieved
- Rapidly enlarging lesions or those with high metabolic activity on PET-CT that warrant surgical resection and lymph node evaluation
- Imaging findings suggesting possible nodal involvement that necessitate surgical dissection for accurate staging
- Pregnant or breastfeeding women
- Inability or unwillingness to comply with study procedures
- Presence of electronic implants (e.g., pacemaker or defibrillator) at risk of interference from microwave energy
- Active pulmonary infection, uncorrectable coagulopathy, or ASA score ≥4
- Patients with multiple lesions requiring both surgery and ablation who cannot represent a single treatment strategy within the study
- Presence of lymph node involvement (N1 or higher) or distant metastases (M1)
- High surgical risk or limited pulmonary reserve where a lung-preserving strategy is preferred.
- Tumours clearly suitable for ablation (≤2.5 cm, located in the middle or peripheral third, and safely ablatable with adequate margins).
- Active pulmonary infection, uncorrectable coagulopathy, or unfit for general anaesthesia or lung resection.
- Patients with multiple lesions, some requiring surgery and others ablation, who cannot be assigned to a single treatment strategy within the study.
- Pregnant or breastfeeding women
- Inability or unwillingness to comply with study procedures
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。