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The objective of the study was to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy (ENB) guided microwave ablation (MWA) for the treatment of early-stage peripheral lung cancer.
The study is designed as a multi-center prospective trial with one arm. There will be 5 centers participating the study. Patients diagnosed with early-stage non-small cell lung cancer (NSCLC) that are nonsurgical candidate will be enrolled in the study. Sixty patients are expected to be enrolled in the study. The purpose of the study is to evaluate the efficacy and safety of ENB guided MWA for the treatment of patients with early-stage nonsurgical NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing bronchoscopic MWA | Experimental | Patients meeting the inclusion criteria will be enrolled in the study and undergo ENB guided MWA. Chest CT will be performed at 1 day after the procedure to confirm the complications and then at 1 month, every 3 months for 2 years, and every 6 months for 3 years thereafter after the procedure. PET/CT will be performed 3 months after MWA to assess the treatment response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MWA | Procedure | Patients diagnosed with early-stage NSCLC and signing the informed consent will undergo MWA with the guidance of ENB. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | Tumor response will be evaluated at 3 months after ablation. Objective response rate(ORR) is the proportion of patients with complete responses and partial responses according to the modified RECIST criteria. | Three months after ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Arrival rate of the locatable wire | Disease progression is evaluated based on the changes of the tumor on computed The arrival rate is the proportion of the locatable wire reaching the location of the tumor accurately. | During the procedure |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayuan Sun, MD, PhD | Contact | 86-021-22200000 | 1511 | jysun1976@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiayuan Sun, MD, PhD | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28683443 | Background | Xie F, Zheng X, Xiao B, Han B, Herth FJF, Sun J. Navigation Bronchoscopy-Guided Radiofrequency Ablation for Nonsurgical Peripheral Pulmonary Tumors. Respiration. 2017;94(3):293-298. doi: 10.1159/000477764. Epub 2017 Jul 6. | |
| 24965604 | Background | Yang X, Ye X, Zheng A, Huang G, Ni X, Wang J, Han X, Li W, Wei Z. Percutaneous microwave ablation of stage I medically inoperable non-small cell lung cancer: clinical evaluation of 47 cases. J Surg Oncol. 2014 Nov;110(6):758-63. doi: 10.1002/jso.23701. Epub 2014 Jun 25. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ENB | Device | ENB (LungCare Medical Technologies Ltd., Inc, Suzhou, China)will be used to guide bronchoscope into the accurate location of the lesion during MWA. |
|
Disease progression is evaluated based on the changes of the tumor on computed tomography (CT) and/or positron emission tomography/computed tomography (PET/CT) according to modified RECIST criteria. |
| At least 3 months |
| Overall survival (OS) | Overall survival(OS) is evaluated after the treatment of ablation until the patient death. | From the time of treatment to the time of the patient death with a follow-up period of 5 years |
| Complication rate | Complications refer to serious operation-related adverse events during and after the operation, such as pneumothorax, bleeding and infection. | From the time of treatment to one month after ablation |
| 26044954 | Background | Koizumi T, Tsushima K, Tanabe T, Agatsuma T, Yokoyama T, Ito M, Kanda S, Kobayashi T, Yasuo M. Bronchoscopy-Guided Cooled Radiofrequency Ablation as a Novel Intervention Therapy for Peripheral Lung Cancer. Respiration. 2015;90(1):47-55. doi: 10.1159/000430825. Epub 2015 May 30. |
| 23870347 | Background | Liu H, Steinke K. High-powered percutaneous microwave ablation of stage I medically inoperable non-small cell lung cancer: a preliminary study. J Med Imaging Radiat Oncol. 2013 Aug;57(4):466-74. doi: 10.1111/1754-9485.12068. Epub 2013 May 8. |
| 21377589 | Background | Sonntag PD, Hinshaw JL, Lubner MG, Brace CL, Lee FT Jr. Thermal ablation of lung tumors. Surg Oncol Clin N Am. 2011 Apr;20(2):369-87, ix. doi: 10.1016/j.soc.2010.11.008. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |