Transbronchial Ablation for Peripheral Lung Tumor
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Radiofrequency ablation group 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. |
Procedure: Radiofrequency ablation
Transbronchial radiofrequency ablation will be performed under the guidance of navigation bronchoscopy.
|
| Experimental: Microwave ablation group 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. |
Procedure: Microwave ablation
Transbronchial microwave ablation will be performed under the guidance of navigation bronchoscopy.
|
Outcome Measures
Primary Outcome Measures
- Local control rate [Three months after ablation]
Local control rate was defined as the proportion of the complete ablation and incomplete ablation of the tumor.
Secondary Outcome Measures
- Progression-free survival (PFS) [From the time of treatment to the time of disease progression or death, assessed up to 1 year]
PFS was defined from the first day after ablation to progression of target lesions and/or appearance of new lesions or death.
- Overall survival（OS） [From the time of treatment to the time of the patient death, assessed up to 3 years]
Overall survival（OS) is evaluated after the treatment of ablation until the patient death.
- Cancer-specific survival [From the time of treatment to the time of the patient death, assessed up to 3 years]
The cause of death is related to the patient's underlying malignancy.
Other Outcome Measures
- Number of participants with treatment-related adverse events as assessed by CTCAE 4.0 [From the time of treatment to the complication occured, assessed up to 1 month]
Complications refer to serious operation-related adverse events during and after the operation,such as pneumothorax, bleeding and infection.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients older than 18 year-old.
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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.
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Chest CT shows the length-diameter of the tumor is more than 8mm and no more than 50mm.
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Patients are unsuitable for surgery assessed by multidisciplinary team and agree to the primary treatment of ablation.
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Patients have good compliance and sign the informed consent.
Exclusion Criteria:
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Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications.
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Patients have contraindications of general anesthesia.
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Chest CT or bronchoscopy shows that guided and treatment instruments cannot reach the peripheral lung lesion.
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There are large blood vessels or important structures adjacent to peripheral lung lesion.
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Researchers consider the patient do not fit for the study due to other reasons.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Chest Hospital | Shanghai | China | 200030 |
Sponsors and Collaborators
- Shanghai Chest Hospital
Investigators
- Principal Investigator: Jiayuan Sun, MD,PhD, Shanghai Chest Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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. Review.
- 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. Review.
- 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.
- 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. Review.
- 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.
- SHCHE201603