Efficacy of a novel lumen-apposing metal stent for the treatment of symptomatic pancreatic pseudocysts
一种新型双蘑菇头金属支架治疗有症状的胰腺假性囊肿的疗效观察
翻译：于廷廷 审校：张立超 侯森林
Background and Aims
Recently, a newly designed lumen-apposing metal stent (LAMS) with a conventional delivery system was developed. The purpose of this study was to evaluate the effectiveness and safety of a newly designed LAMS for EUS-guided drainage to treat symptomatic pancreatic pseudocysts.
背景和目的
最近，开发了一种具有常规推送系统的新设计的双蘑菇头金属支架（LAMS）。 这项研究的目的是评估这种新设计的LAMS在EUS引导下用于治疗有症状的胰腺假性囊肿的有效性和安全性。
Methods
This prospective multicenter cohort study included 34 patients with symptomatic pancreatic pseudocysts from 2016 to 2017. The patients underwent EUS-guided drainage with the newly designed LAMS (Niti-S SPAXUS; Taewoong Medical Co, Ltd, Ilsan, South Korea). Effectiveness outcome measurements included technical success rate, clinical success rate, successful stent removal rate, and procedural time. Safety outcome measurements included procedure and/or stent-related adverse events (AEs) and overall AEs. Patients were prospectively followed, and consecutive data were collected at discharge, at stent removal, and 20 days after stent removal.
方法
这项前瞻性多中心队列研究纳入了2016年至2017年的34例有症状的胰腺假性囊肿患者。患者均在EUS引导下采用新设计的LAMS（Niti-S SPAXUS; Taewoong Medical Co, Ltd, Ilsan, South Korea）进行引流。 有效性结果检测指标包括技术成功率，临床成功率，支架成功移除率和手术时间。 安全性结果检测指标包括手术和/或支架相关的不良事件（AE）和整体不良事件。对患者进行前瞻性随访，收集在出院时，支架拆除时和支架拆除后20天的连续数据。
Results
Thirty-four patients (mean age 51.7 ± 13.3 years, 26 men) were enrolled. The mean pseudocyst size was 9.23 ± 3.54 cm. The technical success rate was 97.1% (33/34). The clinical success rate was 94.1% (32/34). All stents were successfully removed. The mean procedural time from needle puncture to stent deployment was 10.3 ± 5.7 minutes. Four patients (11.8%) experienced procedure and/or stent-related AEs, including stent maldeployment (n = 1) and pseudocyst infection (n = 3). All patients completely recovered from the AEs. Bleeding caused by the stent or buried LAMS syndrome was not observed. No unplanned endoscopic procedures were required.
结果
总共纳入了34例患者（平均年龄51.7±13.3岁，男26例）。假性囊肿的平均大小为9.23±3.54cm。技术成功率为97.1％（33/34）。临床成功率为94.1％（32/34）。所有支架均成功移除。从细针穿刺到支架置入的平均时间为10.3±5.7分钟。 4名患者（11.8％）发生了手术和/或支架相关的不良事件，包括支架移位（n = 1）和假性囊肿感染（n = 3）。 所有患者均从不良事件中完全康复。 没有出现由支架或隐匿性LAMS综合征引起的出血。 无计划外的内窥镜检查。
Conclusions
This study showed that EUS-guided drainage using the newly designed LAMS is technically feasible and effective for the treatment of symptomatic pancreatic pseudocysts.
结论
这项研究表明，使用新设计的LAMS进行在EUS引导下引流治疗有症状的胰腺假性囊肿在技术上是可行、有效的。
本研究中使用的双蘑菇头金属支架LAMS（Niti-S SPAXUS）由镍钛合金制成，并完全覆盖有硅膜。 它们的两端都有较大的蘑菇头，直径为25 mm，用于锚固。支架放置后，两个固定蘑菇头都可以向后反折，以保持两个开口在适当的位置。 支架的可选直径为8、10和16 mm，支架长度为20 mm。 但是，支架展开后，蘑菇头之间的距离为7毫米。
