A Prospective Study of Ablation of Pulmonary Focal Pure Ground Glass Opacity
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The changing of the lesion
研究概览
简要总结
With the advent of CT screening for lung cancer, there is an increase in the detection of pulmonary lesions with focal pure ground-glass opacity (pGGO). The pure Ground-glass opacities can be caused by normal expiration, partial filling of air spaces, partial collapse of alveoli, interstitial thickening, inflammation, oedema, fibrosis, and lepidic proliferation of neoplasm. Precise details of the natural history of focal pure GGO are still largely unclear. A number of differential diagnoses are possible, including inflammatory disease, focal scar, atypical adenomatous hyperplasia (AAH), and adenocarcinoma in situ. Some of pGGOs remained stable over a considerable time. A long doubling time for pGGOs is already known. Therefore, the strategy of treatment for focal pure GGO lesions is still undecided. The major issue is whether or not the doctors should treat these patients at all or wait until the first sign of a solid lesion developes which may take many years.
The purpose of this study is to determine if the ablation therapy is safe and effective for the pulmonary pGGO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The lesion(s) treated with ablation must be =< 2.0 cm in greatest dimension
- •All patients are required to have been evaluated in a multi-disciplinary tumor conference to ensure that the lesion is suitable for Image-guided percutaneous ablation
- •Platelet count ≥ 100 x 109/L
- •International normalized ratio (INR) < 1.5
- •Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- •A signed study specific consent form is required
排除标准
- •Direct evidence of regional or distant metastases,or synchronous primary or prior malignancy in the past 5 years
- •Unable to lie flat or has respiratory distress at rest
- •Uncontrolled coagulopathy or bleeding disorders
- •Evidence of active systemic, pulmonary, or pericardial infection
- •Women who are pregnant or breastfeeding
- •Patients with poor pulmonary function
结局指标
主要结局
The changing of the lesion
时间窗: 3 years
To determine the efficacy rate of CT image guided ablation for pulmonary focal pGGO. To determine the feasibility and safety of CT image guided ablation in patients with pulmonary pGGO.
次要结局
- The side effect of the therapy.(3 years)
研究者
Chen Weisheng
The vice chief of the Thoracic Division
Dongfang Hospital Beijing University of Chinese Medicine