Cryoablation Versus Thoracoscopic Surgery for Pulmonary Ground-Glass Nodules: A Prospective, Comparative, Open Label Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- 2-year disease-free survival
研究概览
简要总结
The aim of this study is to investigate the efficacy and safety of Cryoablation and Thoracoscopic Surgery in the treatment of pulmonary ground-glass nodules.
详细描述
The primary treatment for GGN type lung cancer is surgical resection, typically using video-assisted thoracoscopic surgery (VATS). Image-guided ablation therapy is considered as a treatment option for early-stage lung cancer patients unsuitable for surgery. It has been recommended by several guidelines as one of the curative treatment methods for primary lung cancer. Among various ablation techniques, cryoablation has the lowest complication rate. However, there is currently no research exploring whether cryoablation is not inferior to thoracoscopic surgery in terms of safety and efficacy in treating highly suspected malignant lung GGNs. This study is designed as a prospective, non-randomized study, with 160 patients expected to be enrolled, who will be assigned to cryoablation or video-assisted thoracoscopic surgery treatment groups based on patient preference. The primary endpoint is the 2-year disease-free survival. Secondary endpoints include 1-month mortality rate, overall survival, 5-year disease-free survival, local recurrence rate, VATS/ cryoablation completion rate, safety, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old.
- •The size of the GGN is 8-20mm (with less than 25% solid component), and the number of nodules requiring treatment in the short term is less than
- •Pathological confirmation of the GGN as non-small cell lung cancer; or progression of the GGN during at least 3 months of follow-up, including enlargement of the largest diameter, increase in solid component, or the appearance of a significant solid component in a previously pure GGN, with multidisciplinary discussion (including radiology, thoracic surgery, and pulmonology) suggesting malignancy.
- •No lymph node, pulmonary, or distant metastasis to other organs.
- •After multidisciplinary evaluation, the patient is considered capable of tolerating both surgical and ablation procedures.
- •Unsuitable for radiation therapy or refusal of radiation therapy.
- •Willing to participate in this clinical study and sign the informed consent form.
排除标准
- •Patients in poor general condition, with ECOG physical fitness score >2, unable to tolerate surgery or ablation therapy, or with relevant contraindications.
- •Patients who have previously received other treatments for pulmonary GGNs.
- •Patients with poor compliance.
- •Severe heart, lung, kidney, brain, or other vital organ diseases.
- •Active bacterial or fungal infections.
- •Simultaneous or metachronous (within the past 5 years) double cancers.
- •Women during pregnancy or breast-feeding.
- •History of radiation therapy.
- •Bleeding tendency, abnormal coagulation functions, or coagulation disorders that cannot be corrected after treatment.
- •Contraindications to general anesthesia.
- •Expected survival time < 6 months.
- •The researcher believes that it is not suitable for inclusion.
研究组 & 干预措施
Cryoablation group
Ground-glass nodules were treated using cryoprobe by transbronchial or percutaneous method.
干预措施: Cryoablation (Procedure)
Thoracoscopic Surgery group
Ground-glass nodules were treated by video-assisted thoracoscopic surgery (VATS). Based on the location of the GGN, select the appropriate surgical resection range (wedge resection, segmentectomy, lobectomy, or combined segmentectomy).
干预措施: Thoracoscopic Surgery (Procedure)
结局指标
主要结局
2-year disease-free survival
时间窗: Up to 2 years
Defined as the time from enrollment to the occurrence of disease recurrence, the discovery of new lesions, or death due to any cause.
次要结局
- Local recurrence rate(Up to 5 years)
- 1-month mortality rate(1 month after the treatment)
- Overall survival(Up to 2 years, 5years)
- Forced Vital Capacity (FVC)(3 months after the treatment)
- 5-year disease-free survival(Up to 5 years)
- VATS/ cryoablation completion rate(immediately after the treatment)
- Forced Expiratory Volume in 1 Second (FEV1)(3 months after the treatment)
- Adverse events and serious adverse events(3 months after the treatment)
- Quality of life assessment(1 week after the treatment)
- Length of hospital stay(1 month after the treatment)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital