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      A Novel Tracheobronchial Stent Loaded with 125I Seeds in Patients with Malignant Airway Obstruction Compared to a Conventional Stent: A Prospective Randomized Controlled Study

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          Abstract

          Background

          To evaluate the safety and efficacy of a novel radioactive bare metal stent (RBMS) compared with a conventional bare metal stent (CBMS) in patients with inoperable malignant airway obstruction.

          Methods

          This prospective study was approved by the Institutional Ethics Committee, and informed consent was obtained from each participant. Patients with malignant airway obstruction who had dyspnea were randomly assigned to receive RBMS or CBMS placement. The primary endpoint was stenosis grade, while the secondary endpoints were technical success, overall survival, and complications. A p value of <0·05 was considered statistically significant.

          Results

          Between September 2013 and July 2015, 66 patients with inoperable malignant airway obstruction received stent placement fluoroscopically (33 in either group). The median follow-up time was 154 days (range, 15–335 days). The baseline stenosis was immediately relieved in both groups after stent placement, and the stenosis grades in the RBMS group were significantly lower than that in the CBMS group since the second month ( p < 0·05). The technical success rates of stent placement were 100% in both groups. The median survival in the RBMS group was significantly longer than that in the CBMS group (170 days vs. 123 days, p < 0·05). There was no significant difference in the incidence of complications between the two groups ( p < 0·05).

          Conclusions

          The placement of RBMS in patients with inoperable malignant airway obstruction is feasible and safe, and it significantly reduces restenosis and improves overall survival compared with the placement of CBMS.

          Graphical Abstract

          Highlights

          • The baseline stenosis was immediately relieved in both groups after stent placement.

          • The stenosis grades in the RBMS group were significantly lower than that in the CBMS group since the second month.

          • The technical success rates of stent placement were 100% in both groups.

          • The median survival in the RBMS group was significantly longer than that in the CBMS group.

          • There was no significant difference of the incidence of complications between the two groups.

          Malignant airway obstruction (MAO) is a serious situation of 20-30% cases of lung cancer, resulting in dyspnea, decreased functional status, and asphyxiation risk. Conventional stent placement provides immediate palliation of dyspnea. However, stent restenosis occurs during the follow up. A novel radioactive bare metal stent (RBMS) loaded with 125I seed was developed for preventing such restenosis. Our study showed that placement of RBMS in patients with inoperable malignant airway obstruction is feasible and safe, and it significantly reduces the restenosis and improves overall survival compared with placement of conventional stent.

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          Most cited references 33

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          Central airway obstruction.

          Central airway obstruction is a problem facing all medical and surgical subspecialists caring for patients with chest diseases. The incidence of this disorder appears to be rising because of the epidemic of lung cancer; however, benign causes of central airway obstruction are being seen more frequently as well. The morbidity is significant and if left untreated, death from suffocation is a frequent outcome. Management of these patients is difficult, but therapeutic and diagnostic tools are now available that are beneficial to most patients and almost all airway obstruction can be relieved expeditiously. This review examines current approaches in the workup and treatment of patients suffering from airway impairment. Although large, randomized, comparative studies are not available, data show significant improvement in patient outcomes and quality of life with treatment of central airway obstruction. Clearly, more studies assessing the relative utility of specific airway interventions and their impact on morbidity and mortality are needed. Currently, the most comprehensive approach can be offered at centers with expertise in the management of complex airway disorders and availability of all endoscopic and surgical options.
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            A proposed classification system of central airway stenosis.

            Tracheobronchial stenosis, a serious problem in adults and children, has multiple causes and has been treated in many ways. While developing an international multicentre study to evaluate efficacy of airway stents, it was realised that no adequate description of central airway stenosis regarding type, location and degree has been published. Thus, comparing results of different treatment modalities in different centres has been difficult due to a lack of uniformity of classification. Reports are typically descriptive and precise classification schemes have not adequately addressed either for the trachea or the main bronchi. A standardised classification scheme was proposed with descriptive images and diagrams for rapid and uniform classification of central airway stenosis. The present authors' system divides stenosis into structural and dynamic types and further classifies the disease by degree of stenosis, location and transition zone. Multiple sites can be described and each is transformed into a simple numerical scoring system prompted by a diagram, which can be easily captured for subsequent uniform analysis across sites. A pilot validation of the system, with 18 pulmonologists of varying training background, showed strong precision and agreement between observers. Such a system will enhance the ability to study the effectiveness of treatment modalities for central airway stenosis.
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              Conventional stents versus stents loaded with (125)iodine seeds for the treatment of unresectable oesophageal cancer: a multicentre, randomised phase 3 trial.

              The combination of stent insertion and single high-dose brachytherapy is a feasible and safe palliative treatment regimen in patients with unresectable oesophageal cancer. We aimed to further assess the efficacy of this treatment strategy compared to a conventional covered stent in patients with dysphagia caused by unresectable oesophageal cancer.
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                Author and article information

                Contributors
                Journal
                EBioMedicine
                EBioMedicine
                EBioMedicine
                Elsevier
                2352-3964
                14 June 2018
                July 2018
                14 June 2018
                : 33
                : 269-275
                Affiliations
                Center of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhong-Da Hospital, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China
                Author notes
                [* ]Corresponding author. gjteng@ 123456vip.sina.com
                [1]

                These authors contributed equally as joint first authors.

                Article
                S2352-3964(18)30208-1
                10.1016/j.ebiom.2018.06.006
                6085500
                29909977
                © 2018 Published by Elsevier B.V.

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                Categories
                Research Paper

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