Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In order to conduct a multicenter comparative effectiveness clinical research of phase II to investigate safety and efficacy of applying microwave ablation in patients with Great-glass lung nodules ≤ 3cm, a single center, non-randomized, open label pilot study is conducted to examine the flexibility, safety and efficacy of using Microwave Ablation in Patients with Ground Glass Nodules that are poor candidate of surgery.
Lung cancer is the most common cancer worldwide contributing 13% of the total number of new cases diagnosed. The main treatments of lung cancer are based on surgical resection and adjuvant postoperative chemotherapy. However, the patients who are intolerant of surgery wouldn't be benefit from surgical resection. Microwave ablation provide new choice for lung cancer, which can effectively treat early lung cancer. The diagnosis of early lung cancer can be based on the results of biopsy of ground-glass nodules (GGNs), which is one of the diagnostic criteria for preoperative diagnosis of early lung cancer. The microwave ablation is the good choice for patients who cannot tolerate surgical resection. However, the flexibility, safety and efficacy of using Microwave Ablation in Patients with Ground Glass Nodules are still unclear.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use CT-guided microwave ablation in Ground Glass Nodules ≤ 3cm | Experimental | Patients with Ground Glass Nodules ≤ 3cm were treated with CT-guided microwave ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-guided microwave ablation | Procedure | Using thermal ablation electrode ECO-100AL6 probe target the GGN zone with the guidance performed by CT (Bright Speed Scanner ) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants recruited; Number of participants complied with protocol; Number of participants finished the study; Number of participants withdrew from the study | Feasibility data that help identify potential population target of CT-guided microwave ablation | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events assessed by CTCAE v4.0 | Safety data of CT-guided microwave ablation | 6 months |
| Number of participants successfully removed ground glass nodules and no relapse in follow-up visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Bao, MD | Contact | 13358119776 | 13358119776@189.cn | |
| Peihua Lu, MD | Contact | 13621500031 | 13621500031@189.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuxi People's Hospital | Recruiting | Wuxi | Jiangsu | 214023 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Efficacy data of CT-guided microwave ablation
| 6 months |
| Confounding variables identified that interfere with efficacy of microwave ablation | Age, sex, medical history and ground glass nodules size examined by regression analysis | 6 months |