目的:评估EUS引导下胆总管十二指肠造口术(EUS-CDS)在远端恶性胆道梗阻(MBO)患者中使用腔贴壁金属支架(LAMS)作为主要引流策略的安全性和可行性。
方法:在病理证实为MBO且没有胃出口梗阻的患者中进行前瞻性单中心初步研究。主要结果是技术成功。次要结果包括临床成功,不良事件(AE)和重新干预。该研究在荷兰审判登记处(登记号NL9757)注册。
结果:总体而言,22例患者入组(中位年龄69.5岁[IQR64-75.2]。20/22例患者(91%)获得了技术成功。1例患者发生不良事件,即由于部署不足(5%)而发生穿孔,在相同的程序处理。19/22例患者(86%)取得了临床成功。技术上成功的EUS-CDS后,20例患者中有11例观察到支架功能障碍(55%)。两名患者接受保守治疗,9例患者进行了再干预。一名患者由于暴发性疾病进展而死亡<30天。
结论:本研究证实了使用LAMS作为主要引流策略的EUS-CDS的安全性和可行性。在将带有LAMS的EUS-CDS视为ERCP的有效替代方案之前,应改善支架功能障碍的高发生率。
BACKGROUND: This study aimed to assess the safety and feasibility of endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) using a lumen-apposing metal stent (LAMS) as a primary drainage strategy in patients with distal malignant biliary obstruction (MBO).
METHODS: A prospective, single-center, pilot study was conducted in patients with pathology-confirmed MBO without gastric outlet obstruction. The primary outcome was technical success. Secondary outcomes included clinical success, adverse events (AEs), and reinterventions. The study was registered in the Netherlands Trial Registry (registry number NL9757).
RESULTS: 22 patients were enrolled (median age 69.5 years [interquartile range 64-75.3]). Technical success was achieved in 20/22 patients (91 %). AEs occurred in one patient, namely perforation following inadequate stent deployment (5 %), which was treated in the same procedure. Clinical success was achieved in 19/22 patients (86 %). Stent dysfunction was observed in 11/20 patients (55 %) after technically successful EUS-CDS: two patients were treated conservatively and nine patients underwent reintervention(s). One patient died within ≤ 30 days due to fulminant disease progression.
CONCLUSIONS: The results confirmed the safety and feasibility of EUS-CDS using LAMS as a primary drainage strategy. The high incidence of stent dysfunction should be improved before EUS-CDS with LAMS can be seen as a valid alternative to endoscopic retrograde cholangiopancreatography.
BACKGROUND: This study aimed to assess the safety and feasibility of endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) using a lumen-apposing metal stent (LAMS) as a primary drainage strategy in patients with distal malignant biliary obstruction (MBO).
METHODS: A prospective, single-center, pilot study was conducted in patients with pathology-confirmed MBO without gastric outlet obstruction. The primary outcome was technical success. Secondary outcomes included clinical success, adverse events (AEs), and reinterventions. The study was registered in the Netherlands Trial Registry (registry number NL9757).
RESULTS: 22 patients were enrolled (median age 69.5 years [interquartile range 64–75.3]). Technical success was achieved in 20/22 patients (91 %). AEs occurred in one patient, namely perforation following inadequate stent deployment (5 %), which was treated in the same procedure. Clinical success was achieved in 19/22 patients (86 %). Stent dysfunction was observed in 11/20 patients (55 %) after technically successful EUS-CDS: two patients were treated conservatively and nine patients underwent reintervention(s). One patient died within ≤ 30 days due to fulminant disease progression.
CONCLUSIONS: The results confirmed the safety and feasibility of EUS-CDS using LAMS as a primary drainage strategy. The high incidence of stent dysfunction should be improved before EUS-CDS with LAMS can be seen as a valid alternative to endoscopic retrograde cholangiopancreatography.