What is this study about? This clinical trial aims to compare two treatments for high-risk lung nodules or early-stage lung cancer: interventional ablation (a minimally invasive procedure that destroys tumors with heat or cold) and surgical resection (surgery to remove the tumor). The goal is to determine if ablation is as safe and effective as surgery while preserving more lung function. Why is this important? Lung cancer is a leading cause of cancer deaths worldwide. Early detection improves survival, but surgery can damage lung function. Ablation (e.g., microwave, cryotherapy) is less invasive than surgery and may offer similar outcomes with faster recovery. However, more evidence is needed to confirm its role in early-stage disease.
What is this study about? This clinical trial aims to compare two treatments for high-risk lung nodules or early-stage lung cancer: interventional ablation (a minimally invasive procedure that destroys tumors with heat or cold) and surgical resection (surgery to remove the tumor). The goal is to determine if ablation is as safe and effective as surgery while preserving more lung function. Why is this important? Lung cancer is a leading cause of cancer deaths worldwide. Early detection improves survival, but surgery can damage lung function. Ablation (e.g., microwave, cryotherapy) is less invasive than surgery and may offer similar outcomes with faster recovery. However, more evidence is needed to confirm its role in early-stage disease. Who can participate? Adults aged 20-79 with high-risk lung nodules or early lung cancer. Eligibility criteria: Nodules ≤2 cm on CT scan, no lymph node/distant spread. Good overall health (e.g., normal blood/organ function, no severe heart/lung disease). No recent cancer treatments (e.g., chemotherapy, radiation). Exclusions: Nodules near major blood vessels/chest wall, pregnancy, or uncontrolled medical conditions. What does the study involve? Two treatment groups: Ablation group: Destroy tumors using heat (microwave) or cold (cryoablation). Surgery group: Remove tumors via standard surgery. Follow-up: Regular check-ups for 5 years, including CT scans, lung function tests, and blood work. What are the potential risks? Ablation risks: Pain, bleeding, infection, pneumothorax (collapsed lung), or damage to nearby organs. Surgery risks: Infection, prolonged pain, lung complications (e.g., reduced function), or longer recovery. Both groups may experience recurrence or side effects like fatigue. What are the benefits? Direct benefits: Access to advanced treatments, close monitoring, and potential lung function preservation with ablation. Long-term impact: Help future patients by improving treatment options for early lung cancer. Study Timeline and Locations Duration: 2024-2028 (participants followed for up to 5 years). Locations: 18+ major hospitals across China, including Guangzhou Medical University Affiliated Hospital (lead center), West China Hospital, and Shanghai Chest Hospital. Key Outcomes Measured Relapse-free survival: Time without cancer returning. Safety: Rates of complications (e.g., bleeding, infection). Lung function: Preserved breathing capacity after treatment. Quality of life: Physical and emotional well-being post-treatment. How will results be used? Findings will guide doctors in choosing the best treatment for early lung cancer, balancing effectiveness with quality of life. Results will be published in medical journals and shared at conferences. Contact Information For questions or enrollment: Lead Researcher: Dr. Zhou Chengzhi, Respiratory Medicine, Guangzhou Medical University Affiliated Hospital. Local Sites: Contact participating hospitals listed in the study document. Ethical Approval: This study follows strict ethical guidelines to protect participants. All treatments are voluntary, and participants may withdraw at any time.
Study Type
OBSERVATIONAL
Enrollment
656
Guangzhou Institute of Respiratory Disease (Responsible Party)
Guangzhou, Guangdong, China
relapse-free survival, RFS
Time from grouping to relapse or death from any cause or last contact with a surviving patient (whichever occurs first).
Time frame: Three years, five years
Technical success rate
1\. When the tumour is treated according to a predetermined protocol with complete overlap of the ablation area (ablation border \> tumour border by at least 5 mm), the operation is defined as a technical success when imaging follow-up demonstrates complete macroscopic ablation of the tumour, and technical success is defined as the percentage of the calculation of technical success.
Time frame: Perioperative/Periprocedural
Pulmonary Function Assessment
The process of quantitatively analysing and comprehensively evaluating the functional status of the patient's lungs, such as ventilation and gas exchange, by measuring the patient's first-second force expiratory volume (FEV1) and forceful lung capacity (FVC).
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months.
overall survival, OS
Time from grouping to death from any cause or last contact with surviving patient (whichever occurs first).
Time frame: Three years, five years
local regional resection, LRR
Proportion of tumours with cancer metastases reappearing at the primary site or elsewhere within the same lobe of the lung or in the lung or draining hilar lymph nodes after receiving treatment.
Time frame: Within five years
Security Indicators
Adverse event rates, and operation-related adverse event rates throughout the study: adverse events occurring within 30 days of ablation treatment and operation-related adverse events of surgical treatment (AE\&SAE), evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Time frame: Within six months after surgery
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