Chen Yen-I, Long Clara, Sahai Anand V, Napoleon Bertrand, Donatelli Gianfranco, Kunda Rastislav, Martel Myriam, Chan Shannon M, Arcidiacono Paolo G, Lam Eric, Kongkam Pradermchai, Forbes Nauzer, Larghi Alberto, Mosko Jeffrey D, Van der Merwe Schalk, Gan Seng Ian, Jacques Jeremie, Kenshil Sana, Ratanachu-Ek Thawee, Miller Corey, Saxena Payal, Desilets Etienne, Sandha Gurpal, Alrifae Yousef, Teoh Anthony Y B
Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.
Service de Gastroentérologie, Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada.
Endoscopy. 2025 Apr;57(4):330-338. doi: 10.1055/a-2463-1601. Epub 2024 Nov 6.
Stent misdeployment (SMD) is a feared and poorly characterized technical challenge of endoscopic ultrasound (EUS)-guided choledochoduodenostomy (CDS) using lumen-apposing stents. We aimed to ascertain the rate of stent misdeployment in EUS-CDS for malignant distal biliary obstruction (MDBO) and describe its outcomes while identifying variables associated with its occurrence.
This was a post hoc analysis of two randomized controlled trials comparing EUS-CDS vs. endoscopic retrograde cholangiopancreatography in MDBO. The primary end point was rate of SMD, classified as misdeployment of the distal flange (type I), proximal flange (type II), contralateral bile duct wall injury (type III), or double mucosal puncture (type IV). Multivariable analysis was performed to identify variables associated with SMD and/or technical failure, and with clinical failure or stent dysfunction.
152 patients were included. Technical success was 93.4 %. SMD occurred in 11 patients (7.2 %; 95 %CI 3.1 %-11.4 %): 8 type I, 1 type II, and 2 type III. Endoscopic salvage of SMD was successful in 81.8 %. Misdeployment led to adverse events in four patients (two mild, two moderate), giving an overall SMD-related adverse event rate of 2.6 % (95 %CI 0.7 %-6.6 %). On multivariable analysis, extrahepatic bile duct diameter of ≤ 15 mm was associated with increased odds of SMD and/or technical failure.
SMD was relatively common in EUS-CDS and was associated with an extrahepatic bile duct diameter of ≤ 15 mm. The majority of misdeployments could be rescued endoscopically with low risk for adverse events.
支架部署不当（SMD）是使用管腔对接支架进行内镜超声（EUS）引导下胆总管十二指肠吻合术（CDS）时令人担忧且特征描述不足的技术挑战。我们旨在确定EUS-CDS治疗恶性远端胆管梗阻（MDBO）时支架部署不当的发生率，并描述其结果，同时确定与其发生相关的变量。
这是对两项随机对照试验的事后分析，比较了MDBO患者的EUS-CDS与内镜逆行胰胆管造影。主要终点是SMD的发生率，分为远端凸缘部署不当（I型）、近端凸缘部署不当（II型）、对侧胆管壁损伤（III型）或双黏膜穿刺（IV型）。进行多变量分析以确定与SMD和/或技术失败以及临床失败或支架功能障碍相关的变量。
纳入152例患者。技术成功率为93.4%。11例患者发生SMD（7.2%；95%CI 3.1%-11.4%）：8例I型，1例II型，2例III型。81.8%的SMD通过内镜挽救成功。部署不当导致4例患者出现不良事件（2例轻度，2例中度），总体SMD相关不良事件发生率为2.6%（95%CI 0.7%-6.6%）。多变量分析显示，肝外胆管直径≤15mm与SMD和/或技术失败的几率增加相关。
SMD在EUS-CDS中相对常见，且与肝外胆管直径≤15mm相关。大多数部署不当可通过内镜挽救，不良事件风险较低。
