Clinical Study of Navigation Bronchoscopy Guided Ablation for the Treatment of Peripheral Lung Tumor
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Local control rate
研究概览
简要总结
The objective of the study was to evaluate the efficacy and safety of navigation bronchoscopy guided transbronchial ablation for the treatment of inoperable peripheral lung tumor.
详细描述
The study is aimed to evaluate the efficacy and safety of navigation bronchoscopy guided transbronchial ablation for treating inoperable malignant lung tumor. The study is designed as a single-center prospective trial. The participating centers are Department of pulmonary medicine and endoscopy, Shanghai Chest Hospital,Shanghai Jiao Tong University, China. Patients are divided into two groups, including radiofrequency ablation group and microwave ablation group. Sixty patients are expected to be enrolled into the study with 30 patients in each group.
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 older than 18 year-old.
- •Patients meeting one of the following criteria: 1) patients discovered with peripheral lung lesions that have demonstrated to be lung cancer by pathology with the clinical stage no later than IIA. 2) recurrent or progressive single lesion or solitary intrapulmonary metastasis after surgery, radiotherapy, chemotherapy or other treatment.3) multiple primary lung cancer with the number of tumors no more than 5 and no metastasis. 4) pulmonary metastases with effective treatment of primary disease, the number of metastases no more than 5 and no other metastasis.
- •Chest CT shows the length-diameter of the tumor is more than 8mm and no more than 50mm.
- •Patients are unsuitable for surgery assessed by multidisciplinary team and agree to the primary treatment of ablation.
- •Patients have good compliance and sign the informed consent.
排除标准
- •Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications.
- •Patients have contraindications of general anesthesia.
- •Chest CT or bronchoscopy shows that guided and treatment instruments cannot reach the peripheral lung lesion.
- •There are large blood vessels or important structures adjacent to peripheral lung lesion.
- •Researchers consider the patient do not fit for the study due to other reasons.
结局指标
主要结局
Local control rate
时间窗: Three months after ablation
Local control rate was defined as the proportion of the complete ablation and incomplete ablation of the tumor.
次要结局
- Progression-free survival (PFS)(From the time of treatment to the time of disease progression or death, assessed up to 1 year)
- Overall survival（OS）(From the time of treatment to the time of the patient death, assessed up to 3 years)
- Cancer-specific survival(From the time of treatment to the time of the patient death, assessed up to 3 years)
研究者
Jiayuan Sun
Director, Department of Endoscopy
Shanghai Chest Hospital