Mangiavillano Benedetto, Franchellucci Gianluca, Auriemma Francesco, Ramai Daryl, Larghi Alberto, Paduano Danilo, De Deo Diletta, Calabrese Federica, Gentile Carmine, Fiacca Matteo, Facciorusso Antonio, Repici Alessandro
Gastrointestinal Endoscopy Unit Humanitas - Mater Domini Castellanza Italy.
Department of Biomedical Sciences Humanitas University Milan Italy.
DEN Open. 2025 Mar 23;5(1):e70084. doi: 10.1002/deo2.70084. eCollection 2025 Apr.
Lumen-apposing metal stents have expanded the therapeutic potential of interventional endoscopic ultrasound (EUS). The Hot-Spaxus (Taewoong Medical Co., Ltd.), the second most commonly utilized lumen-apposing metal stent, requires two operators for its release which has been considered a limitation compared to other lumen-apposing metal stents. We aimed to test the feasibility and the technical success of a newly available version of the Hot-Spaxus stent equipped with an innovative handle delivery system for EUS-guided interventional procedures. We conducted a pilot study using porcine models. The novel Hot-Spaxus 2 was tested by performing four EUS-guided procedures including four EUS-guided gallbladder drainage and 12 EUS-guided gastrojejunostomy) procedures. Technical success was reported in 100% of cases. The mean procedure time for EUS-guided gatrojejunostomyJ and EUS-guided gallbladder drainage was 23.85 min (standard deviation 3.41) and 16.15 min (standard deviation 2.72), respectively. The distal and proximal flanges were safely released by the endosonographer without any complications. No adverse events were reported. In conclusion, the novel Hot-Spaxus 2 stent may represent an improvement compared to the prior Spaxus model. Unlike its predecessor, this newly designed stent eliminates the need for two endoscopists and can be deployed by a single operator. Further human studies are necessary to validate its clinical effectiveness.
管腔贴附金属支架扩大了介入性内镜超声（EUS）的治疗潜力。Hot-Spaxus（太宇医疗有限公司）是第二常用的管腔贴附金属支架，其释放需要两名操作人员，与其他管腔贴附金属支架相比，这被认为是一个局限性。我们旨在测试一种新的配备创新手柄输送系统的Hot-Spaxus支架在EUS引导介入手术中的可行性和技术成功率。我们使用猪模型进行了一项试点研究。通过进行四项EUS引导手术，包括四项EUS引导胆囊引流和12项EUS引导胃空肠吻合术，对新型Hot-Spaxus 2进行了测试。100%的病例报告技术成功。EUS引导胃空肠吻合术和EUS引导胆囊引流的平均手术时间分别为23.85分钟（标准差3.41）和16.15分钟（标准差2.72）。超声内镜检查人员安全地释放了远端和近端凸缘，没有任何并发症。未报告不良事件。总之，与之前的Spaxus模型相比，新型Hot-Spaxus 2支架可能有所改进。与前身不同，这种新设计的支架无需两名内镜医师，可由一名操作人员部署。需要进一步的人体研究来验证其临床有效性。
