内镜超声引导下胆总管十二指肠吻合术与肝胃吻合术联合胃肠吻合术治疗恶性双梗阻（CABRIOLET_Pro）：一项前瞻性对比研究。
Endoscopic ultrasound-guided choledochoduodenostomy versus hepaticogastrostomy combined with gastroenterostomy in malignant double obstruction (CABRIOLET_Pro): A prospective comparative study.
作者信息
Vanella Giuseppe, Leone Roberto, Frigo Francesco, Bronswijk Michiel, van Wanrooij Roy L J, Tamburrino Domenico, Orsi Giulia, Belfiori Giulio, Macchini Marina, Reni Michele, Aldrighetti Luca, Falconi Massimo, Capurso Gabriele, van der Merwe Schalk, Arcidiacono Paolo Giorgio
机构信息
Pancreatobiliary Endoscopy and Endosonography Division Pancreas Translational and Clinical Research Center IRCCS San Raffaele Scientific Institute Milan Italy.
Vita-Salute San Raffaele University Milan Italy.
出版信息
DEN Open. 2024 Oct 6;5(1):e70024. doi: 10.1002/deo2.70024. eCollection 2025 Apr.
OBJECTIVES
Malignant double obstruction, defined as the simultaneous presence of biliary and gastric outlet obstruction, represents a challenging clinical scenario. Previous retrospective experiences have demonstrated shorter dysfunction-free survival (DyFS) of endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) versus EUS-hepaticogastrostomy (EUS-HGS) in this setting, but no prospective evidence is available.
METHODS
Twenty consecutive patients with malignant double obstruction, treated with EUS-gastroenterostomy (and EUS-guided biliary drainage, following a previously failed ERCP, were enrolled in a prospective observational study (ClinicalTrials.gov NCT04813055) comparing EUS-CDS versus EUS-HGS. Efficacy and safety were evaluated, with Biliary Dysfunctions as the primary outcome and DyFS using Kaplan-Meier estimates as a primary measure.
RESULTS
Twenty patients (75% with pancreatic cancer, 50% with metastatic disease) with EUS-gastroenterostomy were included (seven EUS-CDS and 13 EUS-HGS). No significant difference was detected at baseline. Technical success was 100% in both groups. EUS-CDS compared to EUS-HGS showed similar clinical success (100% vs. 92.3%, = 0.5), a higher rate of post-procedural adverse events (42.9% vs. 7.7%, = 0.067, mostly related to severe/fatal cholangitis in the EUS-CDS group) and a higher rate of biliary dysfunctions during follow-up (71.4% vs. 16.7%, = 0.002).DyFS was significantly shorter in the EUS-CDS group (39 [15-62] vs. 268 [192-344] days, = 0.0023), with a 30-days DyFS probability of 57.1% vs. 100% (hazard ratio = 7.8 [1.4-44.2]).
CONCLUSIONS
In this prospective comparison of patients with malignant double obstruction undergoing EUS-gastroenterostomy, treating jaundice with EUS-CDS versus EUS-HGS resulted in a reduced probability of survival without biliary events and an increased risk of biliary dysfunctions (number needed to harm = 1.8), with detection of severe/fatal cholangitis.
目的
恶性双重梗阻定义为同时存在胆管和胃出口梗阻，是一种具有挑战性的临床情况。以往的回顾性研究经验表明，在这种情况下，内镜超声引导下胆总管十二指肠吻合术（EUS-CDS）的无功能生存期（DyFS）短于内镜超声引导下肝胃吻合术（EUS-HGS），但尚无前瞻性证据。
方法
连续20例恶性双重梗阻患者接受了内镜超声引导下胃肠吻合术（以及在先前的内镜逆行胰胆管造影术失败后进行的内镜超声引导下胆道引流），纳入一项比较EUS-CDS与EUS-HGS的前瞻性观察研究（ClinicalTrials.gov NCT04813055）。评估了疗效和安全性，以胆道功能障碍为主要结局，以Kaplan-Meier估计的DyFS作为主要衡量指标。
结果
纳入20例接受内镜超声引导下胃肠吻合术的患者（75%为胰腺癌，50%为转移性疾病）（7例行EUS-CDS，13例行EUS-HGS）。基线时未检测到显著差异。两组的技术成功率均为100%。与EUS-HGS相比，EUS-CDS显示出相似的临床成功率（100%对92.3%，P = 0.5），术后不良事件发生率更高（42.9%对7.7%，P = 0.067，主要与EUS-CDS组的严重/致命胆管炎有关），随访期间胆道功能障碍发生率更高（71.4%对16.7%，P = 0.002）。EUS-CDS组的DyFS显著缩短（39[15 - 62]天对268[192 - 344]天，P = 0.0023），30天DyFS概率为57.1%对100%（风险比 = 7.8[1.4 - 44.2]）。
结论
在这项对接受内镜超声引导下胃肠吻合术的恶性双重梗阻患者的前瞻性比较中，与EUS-HGS相比，用EUS-CDS治疗黄疸导致无胆道事件生存概率降低，胆道功能障碍风险增加（伤害所需人数 = 1.8），并检测到严重/致命胆管炎。
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