Supplementary Material for: EUS-Guided Gallbladder Drainage Using an Improved Self-Expandable Covered Metal Stent with Anti-Stent Migration System (with Video)

Background: Recently, lumen-apposing metal stents (LAMS) have been developed as novel devices for not only endoscopic ultrasound (EUS)-guided pancreatic fluid drainage but also for EUS-guided gallbladder drainage (GBD). Although LAMS might be clinically impactful, these stents have not yet become available as EUS-GBD stents in all countries, including Japan. Instead, improved metal stents (NEO stents) have become available. The aim of this pilot study was to evaluate the feasibility and safety of EUS-GBD using the improved metal stent with an anti-stent migration system for acute cholecystitis (AC). Method: The gallbladder was punctured using a 19-G needle, and a 0.025-inch guidewire was inserted into the gallbladder. After fistula dilation, stent deployment was performed from the gallbladder to the duodenum. Finally, a plastic 7-Fr pigtail stent was placed to prevent stent migration. Result: EUS-GBD using NEO stents with the anti-stent migration system was attempted in 12 consecutive patients with AC as a complication of other conditions. EUS-GBD was successfully performed in all patients without any adverse events, and clinical success was achieved in all patients. Median procedure time was 19.0 min (range, 19–24 min). In 4 patients, stent removal was successfully performed after 3 months. Stent migration during follow-up (median, 189 days) was not seen in any of the patients. Conclusion: Although this study has several limitations such as small number of patients and short follow-up period, the results show that NEO stents might be suitable as EUS-GBD stents in selected patients. Our results should be validated by a larger prospective, randomized study.背景：近年来，腔道对接金属支架（lumen-apposing metal stents，LAMS）作为新型器械，不仅被开发用于内镜超声（endoscopic ultrasound，EUS）引导下的胰液引流，还可应用于EUS引导下胆囊引流（gallbladder drainage，GBD）。尽管LAMS具备临床应用价值，但包括日本在内的诸多国家尚未将此类支架作为EUS-GBD支架投入临床使用。目前可供选择的为改良型金属支架（NEO支架）。本先导性研究旨在评估搭载抗支架移位系统的改良型金属支架用于急性胆囊炎（acute cholecystitis，AC）患者行EUS-GBD的可行性与安全性。 方法：采用19G穿刺针穿刺胆囊，并将0.025英寸导丝置入胆囊腔。待瘘道扩张完成后，自胆囊至十二指肠完成支架置入。最终放置7Fr猪尾巴塑料支架以预防支架移位。 结果：共纳入12例因其他疾病并发症并发急性胆囊炎的连续患者，尝试使用搭载抗移位系统的NEO支架行EUS-GBD。所有患者均顺利完成手术，未发生任何不良事件，且均实现临床成功。手术中位时长为19.0分钟（范围：19~24分钟）。其中4例患者于术后3个月成功完成支架取出。随访期间（中位随访时长189天），未观察到任何患者出现支架移位。 结论：尽管本研究存在患者样本量较小、随访周期较短等诸多局限性，但结果显示，NEO支架或可作为经筛选患者行EUS-GBD的适用支架。本研究结果需通过更大规模的前瞻性随机对照研究加以验证。