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| Name | Class |
|---|---|
| Shanghai 10th People's Hospital | OTHER |
| Second Affiliated Hospital of Xiamen Medical College | OTHER |
| Anhui Chest Hospital | OTHER |
| China Meitan General Hospital |
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Malignant central airway stenosis caused by primary or metastatic malignant tumor may lead to dyspnea even death of patients.With the rapid development of interventional pulmonology, bronchoscopic therapy has become the main treatment for malignant central airway stenosis. Metal stent implantation in airway can quickly relieve respiratory obstruction and improve quality of life.However, the tumor tissue can continue to grow into metal stent and obstruct airway again. This is the shortcoming of metal bare stents, which often need further treatment to keep airway open, including ablation, laser, cryotherapy, external radiotherapy or systemic anti-tumor drug therapy.Metal stent implantation combined with external radiotherapy can effectively reduce the incidence of airway restenosis.However, complications of external radiotherapy are high, including bone marrow suppression, radioactive pneumonia, radioactive esophagitis, myocardial injury and tracheoesophageal fistula, of which may cause serious consequences and even cause death of the patient.125I radioactive seeds have been one of the mature radioactive interventional therapy, which release X rays, and γ rays. Because of the short radioactive distance, 125I seeds can destruct tumor cells in tumor site and promote apoptosis and necrosis of tumor cells around the obstruction of the airway, meanwhile cause little damage to the surrounding normal tissues. Some studies showed that 125I seed implantation of lung tumor lesions achieved good short-term results.Therefore, the investigators hypothesize that 125I seeds fixed on the metal bare stent can not only improve the patient's breathing difficulties, but also play a role in killing tumor cells. At present, there have been reports of related clinical cases and monocentric control studies of malignant central airway stenosis treated with the implantation of metal stent with 125I seeds, but there is a lack of multicentric clinical studies with large samples.
It is an open, multicentric randomized controlled clinical trial conducted in China, and plan to recruiting 200 patients who suffer malignant central airway stenosis. To evaluate the efficacy and safety of metal stent with 125I seeds group and metal bare stent group in the treatment of malignant central airway stenosis, follow-up should be done within 1 week, 1 month, and 3 months after the first treatment, followed by every 3 months. The contents include review of bronchoscopy and chest CT, blood routine, immune indicators (IgA, immunoglobulin M(Ig M), IgG), evaluation of general conditions. The patients of the first group need emission-computed tomography(ECT) imaging or positron emission tomography-computed tomography (PET-CT) examination within 1 month. If the patient has severe dyspnea, emergency bronchoscopy should be performed .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A metal bare stent with 125I seeds | Experimental | 125I seeds fixed on the metal bare stent, then stent implantation |
|
| A metal bare stent | Other | A metal bare stent implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stent implantation | Procedure | stent implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| stenosis grade | Stenosis grade was classified as 5 grades on the cross-sectional CT imaging area: grade 0 = non-appreciable stenosis; grade 1, 2, 3, and 4 = 25, 50, 75, and 90% decrease in area, respectively; grade 5 = complete obstruction | the first month after stent implantation |
| stenosis grade | Stenosis grade was classified as 5 grades on the cross-sectional CT imaging area: grade 0 = non-appreciable stenosis; grade 1, 2, 3, and 4 = 25, 50, 75, and 90% decrease in area, respectively; grade 5 = complete obstruction | the third month after stent implantation |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | overall survival | From randomization until death (up to 24 months) |
| technical success | successful implantation of the stent across the stricture with appropriate positioning of the stent and full expansion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengshui Chen, doctor | Contact | 86 13806889081 | 8613806889081 | wzchencs@163.com |
| Xiaoxiao Lin, doctor | Contact | 8615068252060 | 8615068252060 | 295357950@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Chengshui Chen, doctor | First Affiliated Hospital of Wenzhou Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of wenzhou medical university | Wenzhou | Zhejiang | 325000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15187010 | Result | Ernst A, Feller-Kopman D, Becker HD, Mehta AC. Central airway obstruction. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1278-97. doi: 10.1164/rccm.200210-1181SO. | |
| 30254139 | Result | Ong P, Grosu HB, Debiane L, Casal RF, Eapen GA, Jimenez CA, Noor L, Ost DE. Long-term quality-adjusted survival following therapeutic bronchoscopy for malignant central airway obstruction. Thorax. 2019 Feb;74(2):141-156. doi: 10.1136/thoraxjnl-2018-211521. Epub 2018 Sep 25. |
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| OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| West China Hospital | OTHER |
| The Second Affiliated Hospital of Fujian Medical University | OTHER |
| Wuhan Central Hospital | OTHER |
| Wuhan No.1 Hospital | OTHER |
| Hunan People's Hospital | UNKNOWN |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Yichang Central People's Hospital | OTHER |
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| one week after stent implantation |
| complications and side effects | Possible radiation related complications included neutropenia, decrease in IgA, IgG, and IgM, and leakage of radioactive seeds.Neutropenia was defined as a total white blood cell count b4000/mm3 in the plasma. The leakage of radioactive seeds was defined as the detection of non-target radioactive source verified by radiography | From randomization until death (up to 24 months) |
| tumor growth rate | the size of tumor assessed by CT after stent implantation | From randomization until death (up to 24 months) |
| the time of emergency endoscopic treatment | record the time of emergency endoscopic treatment for the recurrent severe dyspnea of patient | From randomization until death (up to 24 months) |
| 12842534 | Result | Wood DE, Liu YH, Vallieres E, Karmy-Jones R, Mulligan MS. Airway stenting for malignant and benign tracheobronchial stenosis. Ann Thorac Surg. 2003 Jul;76(1):167-72; discussion 173-4. doi: 10.1016/s0003-4975(03)00033-x. |
| 14605078 | Result | Saad CP, Murthy S, Krizmanich G, Mehta AC. Self-expandable metallic airway stents and flexible bronchoscopy: long-term outcomes analysis. Chest. 2003 Nov;124(5):1993-9. doi: 10.1378/chest.124.5.1993. |
| 29538079 | Result | Sabath BF, Ost DE. Update on airway stents. Curr Opin Pulm Med. 2018 Jul;24(4):343-349. doi: 10.1097/MCP.0000000000000486. |
| 16039180 | Result | Lemaire A, Burfeind WR, Toloza E, Balderson S, Petersen RP, Harpole DH Jr, D'Amico TA. Outcomes of tracheobronchial stents in patients with malignant airway disease. Ann Thorac Surg. 2005 Aug;80(2):434-7; discussion 437-8. doi: 10.1016/j.athoracsur.2005.02.071. |
| 22516383 | Result | Rochet N, Hauswald H, Schmaus M, Hensley F, Huber P, Eberhardt R, Herth FJ, Debus J, Neuhof D. Safety and efficacy of thoracic external beam radiotherapy after airway stenting in malignant airway obstruction. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):e129-35. doi: 10.1016/j.ijrobp.2011.11.055. |
| 24745612 | Result | Qu A, Wang H, Li J, Wang J, Liu J, Hou Y, Huang L, Zhao Y. Biological effects of (125)i seeds radiation on A549 lung cancer cells: G2/M arrest and enhanced cell death. Cancer Invest. 2014 Jul;32(6):209-17. doi: 10.3109/07357907.2014.905585. Epub 2014 Apr 18. |
| 29909977 | Result | Wang Y, Lu J, Guo JH, Zhu GY, Zhu HD, Chen L, Wang C, Teng GJ. A Novel Tracheobronchial Stent Loaded with 125I Seeds in Patients with Malignant Airway Obstruction Compared to a Conventional Stent: A Prospective Randomized Controlled Study. EBioMedicine. 2018 Jul;33:269-275. doi: 10.1016/j.ebiom.2018.06.006. Epub 2018 Jun 14. |
| 26171002 | Result | Lu M, Pu D, Zhang W, Liao J, Zhang T, Yang G, Liu Z, Singh S, Gao F, Zhang F. Trans-bronchoscopy with implantation of 125I radioactive seeds in patients with pulmonary atelectasis induced by lung cancer. Oncol Lett. 2015 Jul;10(1):216-222. doi: 10.3892/ol.2015.3204. Epub 2015 May 13. |
| 17157949 | Result | Mallick I, Sharma SC, Behera D. Endobronchial brachytherapy for symptom palliation in non-small cell lung cancer--analysis of symptom response, endoscopic improvement and quality of life. Lung Cancer. 2007 Mar;55(3):313-8. doi: 10.1016/j.lungcan.2006.10.018. Epub 2006 Dec 8. |
| 28389860 | Result | Wang Y, Guo JH, Zhu GY, Zhu HD, Chen L, Lu J, Wang C, Teng GJ. A Novel Self-Expandable, Radioactive Airway Stent Loaded with 125I Seeds: A Feasibility and Safety Study in Healthy Beagle Dog. Cardiovasc Intervent Radiol. 2017 Jul;40(7):1086-1093. doi: 10.1007/s00270-017-1639-8. Epub 2017 Apr 7. |