多中心随机对照研究（ELEMENT试验）：内镜超声引导的一期选择性与内镜逆行胆管胰管造影术治疗恶性远端胆道梗阻的胆管引流：以腔导金属支架为例。
Endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs. endoscopic retrograde cholangiopancreatography in malignant distal biliary obstruction: a multicenter randomized controlled study (ELEMENT trial).
发表日期：2023 Aug 05
作者：
Yen-I Chen, Anand Sahai, Gianfranco Donatelli, Eric Lam, Nauzer Forbes, Jeffrey Mosko, Sarto C Paquin, Fergal Donnellan, Avijit Chatterjee, Jennifer Telford, Corey Miller, Etienne Desilets, Gurpal Sandha, Sana Kenshil, Rachid Mohamed, Gary May, Ian Gan, Jeffrey Barkun, Natalia Calo, Abrar Nawawi, Gad Friedman, Albert Cohen, Thibaut Maniere, Prosanto Chaudhury, Peter Metrakos, George Zogopoulos, Ali Bessissow, Jad Abou Khalil, Vicky Baffis, Kevin Waschke, Josee Parent, Constantine Soulellis, Mouen Khashab, Rastislav Kunda, Olivia Geraci, Myriam Martel, Kevin Schwartzman, Julio F Fiore, Elham Rahme, Alan Barkun
来源：
GASTROENTEROLOGY
摘要：
通过内镜超声引导胆总管空肠造口术（EUS-CDS）配合管腔吻合金属支架是一种有前途的方法，用于处理恶性远端胆道梗阻（MDBO），具有更好的支架通畅性潜力。我们将其结果与内镜逆行胰胆管造影与金属支架插入术（ERCP-M）进行比较。在这项多中心、随机、对照试验中，我们招募了10家加拿大和1家法国的机构的MDBO继发于边界可切除、局部晚期或不可切除的球后癌患者。这是一项具有非劣性评估技术成功的优越性试验。患者被随机分配到EUS-CDS组或ERCP-M组。主要终点是1年内发生支架功能障碍的比例，考虑死亡、临床失败和手术切除的竞争风险。根据意向治疗（ITT）原则进行分析。从2019年2月至2022年2月，共招募了144名患者，其中73名随机分配到EUS-CDS组，71名随机分配到ERCP-M组。平均手术时间为14.0±11.4分钟，EUS-CDS组与23.1±15.6分钟的ERCP-M组相比（p<0.01），其中40%的手术不使用透视。EUS-CDS组和ERCP-M组的技术成功率分别为90.4%（81.5%; 95.3%）和83.1%（72.7%; 90.1%），风险差异为7.3%（-4.0%; 18.8%），表明非劣性。EUS-CDS组和ERCP-M组的支架功能障碍发生率分别为9.6%和9.9%（p=0.96）。未注意到不良事件、胰头十二指肠切除术和肿瘤学结果或生活质量的差异。虽然在支架功能方面并不优越，但EUS-CDS对于MDBO患者是一种高效且安全的替代方法。这些发现为在MDBO患者中更广泛地采用EUS-CDS作为内镜逆行胰胆管造影的互补和可替代的一线模式提供了证据（https://clinicaltrials.gov/ct2/show/NCT03870386）。版权©2023 AGA Institute。由Elsevier Inc.出版。保留所有权利。
Endosonography-guided choledochoduodenostomy with a lumen-apposing metal stent (EUS-CDS) is a promising modality for the management of malignant distal biliary obstruction (MDBO) with potential for better stent patency. We compared its outcomes with endoscopic retrograde cholangiopancreatography with metal stenting (ERCP-M).In this multicenter, randomized, controlled trial, we recruited patients with MDBO secondary to borderline resectable, locally advanced, or unresectable peri-ampullary cancers across 10 Canadian and one French institution(s). This was a superiority trial with a non-inferiority assessment of technical success. Patients were randomized to EUS-CDS or ERCP-M. The primary endpoint was the rate of stent dysfunction at 1 year, considering competing risks of death, clinical failure, and surgical resection. Analyses were performed according to intention-to-treat (ITT) principles.From February 2019 to February 2022, 144 patients were recruited with 73 randomized to EUS-CDS and 71 to ERCP-M. The mean procedure time was 14.0±11.4 min with EUS-CDS vs. 23.1±15.6 with ERCP-M (p<0.01), with 40% of the former performed without fluoroscopy. Technical success was achieved in 90.4% (81.5%; 95.3%) of EUS-CDS and 83.1% (72.7%; 90.1%) of ERCP-M with a risk difference of 7.3% (-4.0%; 18.8%) indicating non-inferiority. Stent dysfunction occurred in 9.6% vs. 9.9% of EUS-CDS and ERCP-M cases, respectively (p=0.96). No differences in adverse events, pancreaticoduodenectomy and oncological outcomes, or quality of life were noted.Although not superior in stent function, EUS-CDS is an efficient and safe alternative to ERCP-M in patients with MDBO. These findings provide evidence for greater adoption of EUS-CDS in clinical practice as a complementary and exchangeable first-line modality to ERCP in patients with MDBO (https://clinicaltrials.gov/ct2/show/NCT03870386).Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved.