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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03944408
Recruitment Status Not yet recruiting
First Posted May 9, 2019
Last update posted May 9, 2019
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 .
|Other: A metal bare stent
A metal bare stent implantation
Procedure: stent implantation
|Experimental: A metal bare stent with 125I seeds
125I seeds fixed on the metal bare stent, then stent implantation
Procedure: stent implantation
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. Age range: 18-75 years old, male or female who is not pregnant
2. Comply with the diagnosis of malignant central airway stenosis, and undergo chest CT
or bronchoscopy to confirm that the stenosis degree is above 50% and need to be
implanted with airway metal stent; or the patient has obvious dyspnea due to airway
stenosis, obstructive pneumonia
3. Subjects voluntarily joined the study and signed informed consent, with good
compliance and follow-up.
4. Unable or refused surgery
5. Unable or refused external radiation therapy
6. Unable or refuse systemic tumor-related drugs therapy within 3 months
1. The distal end of the stenosis is unpredictable, and the stent treatment may not be
2. Severe arrhythmia, acute myocardial ischemia, uncontrollable hypertensive crisis;
3. Severe coagulopathy
4. Severe organ dysfunction (except respiratory insufficiency)
5. Allergic to anesthetics
6. Airway fistula lesions
7. The narrow lesion involves 2cm inside the glottis
8. History of extrathoracic radiation therapy in the past 6 months
9. Severe myelosuppression
Contact: Chengshui Chen, doctor 86 13806889081 ext 8613806889081 email@example.com
Contact: Xiaoxiao Lin, doctor 8615068252060 ext 8615068252060 firstname.lastname@example.org
The first affiliated hospital of wenzhou medical university
First Affiliated Hospital of Wenzhou Medical University
Shanghai 10th People's Hospital
The Second Affiliated Hospital of Xiamen Medical College
Anhui Chest Hospital
China Meitan General Hospital
The Second Hospital of Hebei Medical University
West China Hospital
The Second Affiliated Hospital of Fujian Medical University
The Central Hospital of Wuhan
Wuhan No.1 Hospital
Hunan People's Hospital
First Affiliated Hospital of Chongqing Medical University
Yichang Central People's Hospital
Study Chair: Chengshui Chen, doctor First Affiliated Hospital of Wenzhou Medical University
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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.
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.
Wang Y, Lu J, Guo JH, Zhu GY, Zhu HD, Chen L, Wang C, Teng GJ. A Novel Tracheobronchial Stent Loaded with (125)I 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.
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 (125)I radioactive seeds in patients with pulmonary atelectasis induced by lung cancer. Oncol Lett. 2015 Jul;10(1):216-222. Epub 2015 May 13.
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. Epub 2006 Dec 8.
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 (125)I 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.