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A pilot study of Spring Stopper Stents: Novel partially covered self-expandable metallic stents with anti-migration properties for EUS-guided hepaticogastrostomy.
Endoscopic Ultrasound ( IF 4.5 ) Pub Date : 2023-01-01 , DOI: 10.4103/eus-d-22-00104
Shigeto Ishii 1 , Hiroyuki Isayama 1 , Naoki Sasahira 2 , Saburo Matsubara 3 , Yousuke Nakai 4 , Toshio Fujisawa 1 , Ko Tomishima 1 , Takashi Sasaki 2 , Kazunaga Ishigaki 5 , Hirofumi Kogure 6 , Takeshi Okamoto 2 , Takeshi Otsuka 3 , Yusuke Takasaki 1 , Akinori Suzuki 1
Affiliation  

Background and Objectives EUS-guided hepaticogastrostomy (EUS-HGS) is an effective salvage procedure when conventional endoscopic transpapillary biliary drainage is difficult or fails. However, the risk of stent migration into the abdominal cavity has not been resolved completely. In this study, we evaluated a newly developed partially covered self-expandable metallic stent (PC-SEMS) that has a spring-like anchoring function on the gastric side. Methods This retrospective pilot study took place at four referral centers in Japan between October 2019 and November 2020. We enrolled 37 cases consecutively who underwent EUS-HGS for unresectable malignant biliary obstruction. Results The rates of technical and clinical success were 97.3% and 89.2%, respectively. Technical failures included one case in which the stent was dislocated during the removal of the delivery system, requiring additional EUS-HGS on another branch. Early adverse events (AEs) were observed in four patients (10.8%): two with mild peritonitis (5.4%) and one each (2.7%) with fever and bleeding. No late AEs were observed during the mean follow-up period of 5.1 months. All recurrent biliary obstructions (RBOs) were stent occlusions (29.7%). The median cumulative time to RBO was 7.1 months (95% confidence interval, 4.3 to not available). Although stent migration in which the stopper was in contact with the gastric wall on follow-up computed tomography was observed in six patients (16.2%), no migration was observed. Conclusions The newly developed PC-SEMS is feasible and safe for the EUS-HGS procedure. The spring-like anchoring function on the gastric side is an effective anchor preventing migration.

中文翻译:

弹簧塞支架的初步研究:新型部分覆盖的自膨胀金属支架,具有抗迁移特性,用于 EUS 引导的肝胃造口术。

背景和目的当传统内镜下经乳头胆管引流困难或失败时,超声内镜引导下肝胃造口术(EUS-HGS)是一种有效的挽救手术。然而,支架迁移到腹腔的风险尚未完全解决。在这项研究中,我们评估了一种新开发的部分覆盖自扩张金属支架(PC-SEMS),它在胃侧具有类似弹簧的锚定功能。方法 这项回顾性试点研究于 2019 年 10 月至 2020 年 11 月在日本的四个转诊中心进行。我们连续招募了 37 例因不可切除的恶性胆道梗阻而接受 EUS-HGS 的患者。结果技术成功率97.3%,临床成功率89.2%。技术故障包括在移除输送系统期间支架脱位的情况,需要在另一个分支上安装额外的 EUS-HGS。在 4 名患者 (10.8%) 中观察到早期不良事件 (AE):两名患有轻度腹膜炎 (5.4%),各一名 (2.7%) 患有发烧和出血。在平均 5.1 个月的随访期内没有观察到晚期 AE。所有复发性胆道梗阻 (RBO) 均为支架闭塞 (29.7%)。RBO 的中位累积时间为 7.1 个月(95% 置信区间,4.3 至不可用)。尽管在后续计算机断层扫描中观察到 6 名患者 (16.2%) 发现支架发生移位,其中塞子与胃壁接触,但没有观察到移位。结论 新开发的 PC-SEMS 对于 EUS-HGS 手术是可行且安全的。胃侧的弹簧状锚定功能是防止迁移的有效锚定。
更新日期:2023-01-01
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