Stent misdeployment and factors associated with failure in endoscopic ultrasound-guided choledochoduodenostomy: analysis of the combined datasets from two randomized trials.

IF 11.5 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Endoscopy Pub Date : 2024-12-16 DOI:10.1055/a-2463-1601
Yen-I Chen, Clara Long, Anand V Sahai, Bertrand Napoleon, Gianfranco Donatelli, Rastislav Kunda, Myriam Martel, Shannon M Chan, Paolo G Arcidiacono, Eric Lam, Pradermchai Kongkam, Nauzer Forbes, Alberto Larghi, Jeffrey D Mosko, Schalk Van der Merwe, Seng Ian Gan, Jeremie Jacques, Sana Kenshil, Thawee Ratanachu-Ek, Corey Miller, Payal Saxena, Etienne Desilets, Gurpal Sandha, Yousef Alrifae, Anthony Y B Teoh
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Abstract

Background:  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.

Method:  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.

Results:  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.

Conclusion:  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.

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EUS引导下胆总管十二指肠造口术中的支架错置和失败相关因素:对ELEMENT和DRA-MBO试验合并数据集的分析。
背景:支架错置(SMD)是使用腔内贴合支架(EUS-CDS)在 EUS 引导下进行胆总管十二指肠造口术的一个令人担忧的技术难题,其特征还不十分明确。我们旨在确定 EUS-CDS 治疗恶性远端胆道梗阻(MDBO)的 SMD 发生率,并描述其结果,同时确定与发生率相关的变量。此外,我们还希望提出一种全新的 SMD 分类方法:方法:对两项 RCT 进行事后分析,比较 EUS-CDS 与内镜逆行胰胆管造影在 MDBO 中的应用。主要终点是SMD的发生率,SMD分为远端法兰错置(I型)、近端法兰错置(II型)、对侧胆管壁损伤(III型)或双粘膜穿刺(IV型)。进行了多变量分析,以确定与 SMD 和/或技术失败以及临床失败或支架功能障碍几率相关的变量:共纳入 152 例患者,技术成功率为 93.4%。11例(7.2%)患者出现了SMD(95% CI,3.1%-11.4%):8例I型,1例II型,2例III型。81.8%的患者成功进行了内镜下抢救。SMD导致的不良事件(AE)有4例(2例轻度,2例中度),总体不良事件发生率为2.6%(95% CI,0.7%-6.6%)。多变量分析显示,肝外胆管直径≤15 mm与SMD和/或技术失败几率增加有关:结论:SMD在EUS-CDS中较为常见,与肝外胆管直径≤15毫米有关。大多数 SMD 可在内镜下抢救,发生 AE 的风险较低。
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来源期刊
Endoscopy
Endoscopy 医学-外科
CiteScore
5.80
自引率
11.80%
发文量
1401
审稿时长
2 months
期刊介绍: Endoscopy is a leading journal covering the latest technologies and global advancements in gastrointestinal endoscopy. With guidance from an international editorial board, it delivers high-quality content catering to the needs of endoscopists, surgeons, clinicians, and researchers worldwide. Publishing 12 issues each year, Endoscopy offers top-quality review articles, original contributions, prospective studies, surveys of diagnostic and therapeutic advances, and comprehensive coverage of key national and international meetings. Additionally, articles often include supplementary online video content.
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