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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency ablation group | Experimental | Patients with inoperable peripheral lung tumor will be performed transbronchial radiofrequency ablation with the guidance of navigation bronchoscopy. Post treatment response will be evaluated and follow up will be carried out according to the standard procedure. |
|
| Microwave ablation group | Experimental | Patients with inoperable peripheral lung tumor will be performed transbronchial microwave ablation with the guidance of navigation bronchoscopy. Post treatment response will be evaluated and follow up will be carried out according to the standard procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation | Procedure | Transbronchial radiofrequency ablation will be performed under the guidance of navigation bronchoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local control rate | Local control rate was defined as the proportion of the complete ablation and incomplete ablation of the tumor. | Three months after ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS was defined from the first day after ablation to progression of target lesions and/or appearance of new lesions or death. | From the time of treatment to the time of disease progression or death, assessed up to 1 year |
| Overall survival（OS） |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE 4.0 | 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 the complication occured, assessed up to 1 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayuan Sun, MD,PhD | Contact | 86-021-22200000-1521 | 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 | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27292045 | Background | Harris K, Puchalski J, Sterman D. Recent Advances in Bronchoscopic Treatment of Peripheral Lung Cancers. Chest. 2017 Mar;151(3):674-685. doi: 10.1016/j.chest.2016.05.025. Epub 2016 Jun 10. | |
| 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. |
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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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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Microwave ablation | Procedure | Transbronchial microwave ablation will be performed under the guidance of navigation bronchoscopy. |
|
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, assessed up to 3 years |
| Cancer-specific survival | The cause of death is related to the patient's underlying malignancy. | From the time of treatment to the time of the patient death, assessed up to 3 years |
| 23601905 | Background | Jahangeer S, Forde P, Soden D, Hinchion J. Review of current thermal ablation treatment for lung cancer and the potential of electrochemotherapy as a means for treatment of lung tumours. Cancer Treat Rev. 2013 Dec;39(8):862-71. doi: 10.1016/j.ctrv.2013.03.007. Epub 2013 Apr 17. |
| 18651356 | Background | Wasser EJ, Dupuy DE. Microwave ablation in the treatment of primary lung tumors. Semin Respir Crit Care Med. 2008 Aug;29(4):384-94. doi: 10.1055/s-2008-1081281. |
| 15746749 | Background | Fernando HC, De Hoyos A, Landreneau RJ, Gilbert S, Gooding WE, Buenaventura PO, Christie NA, Belani C, Luketich JD. Radiofrequency ablation for the treatment of non-small cell lung cancer in marginal surgical candidates. J Thorac Cardiovasc Surg. 2005 Mar;129(3):639-44. doi: 10.1016/j.jtcvs.2004.10.019. |
| 26096694 | Background | Dupuy DE, Fernando HC, Hillman S, Ng T, Tan AD, Sharma A, Rilling WS, Hong K, Putnam JB. Radiofrequency ablation of stage IA non-small cell lung cancer in medically inoperable patients: Results from the American College of Surgeons Oncology Group Z4033 (Alliance) trial. Cancer. 2015 Oct 1;121(19):3491-8. doi: 10.1002/cncr.29507. Epub 2015 Jun 19. |
| 26273346 | Background | Ye X, Fan W, Chen JH, Feng WJ, Gu SZ, Han Y, Huang GH, Lei GY, Li XG, Li YL, Li ZJ, Lin ZY, Liu BD, Liu Y, Peng ZM, Wang H, Yang WW, Yang X, Zhai B, Zhang J. Chinese expert consensus workshop report: Guidelines for thermal ablation of primary and metastatic lung tumors. Thorac Cancer. 2015 Jan;6(1):112-21. doi: 10.1111/1759-7714.12152. Epub 2015 Jan 7. |
| 35166043 | Derived | Xie F, Chen J, Jiang Y, Sun J, Hogarth DK, Herth FJF. Microwave ablation via a flexible catheter for the treatment of nonsurgical peripheral lung cancer: A pilot study. Thorac Cancer. 2022 Apr;13(7):1014-1020. doi: 10.1111/1759-7714.14351. Epub 2022 Feb 14. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |