Giuseppe Vanella, Roberto Leone, Francesco Frigo, Michiel Bronswijk, Roy L. J. van Wanrooij, Domenico Tamburrino, Giulia Orsi, Giulio Belfiori, Marina Macchini, Michele Reni, Luca Aldrighetti, Massimo Falconi, Gabriele Capurso, Schalk van der Merwe, Paolo Giorgio Arcidiacono
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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.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>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%, <i>p</i> = 0.5), a higher rate of post-procedural adverse events (42.9% vs. 7.7%, <i>p</i> = 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%, <i>p</i> = 0.002).</p>\n \n <p>DyFS was significantly shorter in the EUS-CDS group (39 [15–62] vs. 268 [192–344] days, <i>p</i> = 0.0023), with a 30-days DyFS probability of 57.1% vs. 100% (hazard ratio = 7.8 [1.4–44.2]).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>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.</p>\n </section>\n </div>","PeriodicalId":93973,"journal":{"name":"DEN open","volume":"5 1","pages":""},"PeriodicalIF":1.4000,"publicationDate":"2024-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11456614/pdf/","citationCount":"0","resultStr":"{\"title\":\"Endoscopic ultrasound-guided choledochoduodenostomy versus hepaticogastrostomy combined with gastroenterostomy in malignant double obstruction (CABRIOLET_Pro): A prospective comparative study\",\"authors\":\"Giuseppe Vanella, Roberto Leone, Francesco Frigo, Michiel Bronswijk, Roy L. 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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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>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%, <i>p</i> = 0.5), a higher rate of post-procedural adverse events (42.9% vs. 7.7%, <i>p</i> = 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%, <i>p</i> = 0.002).</p>\\n \\n <p>DyFS was significantly shorter in the EUS-CDS group (39 [15–62] vs. 268 [192–344] days, <i>p</i> = 0.0023), with a 30-days DyFS probability of 57.1% vs. 100% (hazard ratio = 7.8 [1.4–44.2]).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>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.</p>\\n </section>\\n </div>\",\"PeriodicalId\":93973,\"journal\":{\"name\":\"DEN open\",\"volume\":\"5 1\",\"pages\":\"\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2024-10-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11456614/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"DEN open\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/deo2.70024\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"DEN open","FirstCategoryId":"1085","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/deo2.70024","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的：恶性双梗阻是指同时存在胆道和胃出口梗阻，是一种具有挑战性的临床情况。以往的回顾性经验表明，在这种情况下，内镜超声引导下胆总管十二指肠造口术（EUS-CDS）与 EUS 肝胃造口术（EUS-HGS）相比，无功能障碍生存期（DyFS）更短，但目前尚无前瞻性证据：一项前瞻性观察研究（ClinicalTrials.gov NCT04813055）比较了 EUS-CDS 与 EUS-HGS 的疗效和安全性。研究以胆道功能障碍为主要结果，以 Kaplan-Meier 估计的 DyFS 为主要测量指标，对疗效和安全性进行了评估：共纳入了 20 例 EUS 胃肠造口术患者（75% 患有胰腺癌，50% 患有转移性疾病）（7 例 EUS-CDS 和 13 例 EUS-HGS）。两组基线无明显差异。两组的技术成功率均为 100%。EUS-CDS 与 EUS-HGS 相比，临床成功率相似（100% vs. 92.3%，p = 0.5），术后不良事件发生率较高（42.9% vs. 7.7%，p = 0.067，EUS-CDS 组主要与严重/致命性胆管炎有关），随访期间胆道功能障碍发生率较高（71.EUS-CDS组的DyFS明显更短（39 [15-62] vs. 268 [192-344] 天，p = 0.0023），30天DyFS概率为57.1% vs. 100%（危险比=7.8 [1.4-44.2]）：在对接受 EUS 胃肠造口术的恶性双梗阻患者进行的这项前瞻性比较中，用 EUS-CDS 与 EUS-HGS 治疗黄疸会导致无胆道事件的生存概率降低，胆道功能障碍的风险增加（需要伤害的人数 = 1.8），并可检测到严重/致命性胆管炎。
Endoscopic ultrasound-guided choledochoduodenostomy versus hepaticogastrostomy combined with gastroenterostomy in malignant double obstruction (CABRIOLET_Pro): A prospective comparative study
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%, p = 0.5), a higher rate of post-procedural adverse events (42.9% vs. 7.7%, p = 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%, p = 0.002).
DyFS was significantly shorter in the EUS-CDS group (39 [15–62] vs. 268 [192–344] days, p = 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.
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