Khashab Mouen A, Van der Merwe Schalk, Kunda Rastislav, El Zein Mohamad H, Teoh Anthony Y, Marson Fernando P, Fabbri Carlo, Tarantino Ilaria, Varadarajulu Shyam, Modayil Rani J, Stavropoulos Stavros N, Peñas Irene, Ngamruengphong Saowanee, Kumbhari Vivek, Romagnuolo Joseph, Shah Raj, Kalloo Anthony N, Perez-Miranda Manuel, Artifon Everson L
Johns Hopkins Medical Institute, Baltimore, MD, USA.
Department of Hepatology, Division of Liver, and Pancreatico-Biliary Disorders, University Hospital Gastuisberg, University of Leuven, Leuven Belgium.
Endosc Int Open. 2016 Apr;4(4):E487-96. doi: 10.1055/s-0042-102648. Epub 2016 Mar 30.
Endoscopic ultrasound-guided biliary drainage (EUS-BD) has emerged as an alternative to traditional radiologic and surgical drainage procedures after failed endoscopic retrograde cholangiopancreatography (ERCP). However, prospective multicenter data are lacking. The aims of this study were to prospectively assess the short- and long-term efficacy and safety of EUS-BD in patients with malignant distal biliary obstruction.
Consecutive patients at 12 tertiary centers (5 US, 5 European, 1 Asian, 1 South American) with malignant distal biliary obstruction and failed ERCP underwent EUS-BD. Technical success was defined as successful stent placement in the desired position. Clinical success was defined as a reduction in bilirubin by 50 % at 2 weeks or to below 3 mg/dL at 4 weeks. Adverse events were prospectively tracked and graded according to the American Society for Gastrointestinal Endoscopy (ASGE) lexicon's severity grading system. Overall survival and duration of stent patency were calculated using Kaplan-Meier analysis.
A total of 96 patients (mean age 66 years, female 45 %, pancreatic cancer 55 %) underwent EUS-BD. Stent placement (technical success) was achieved in 92 (95.8 %) patients (metallic stent 84, plastic stent 8). Mean procedure time was 40 minutes. Clinical success was achieved in 86 (89.5 %) patients. A total of 10 (10.5 %) adverse events occurred: pneumoperitoneum (n = 2), sheared wire (n = 1), bleeding (n = 1), bile leak (n = 3), cholangitis (n = 2), and unintentional perforation (n = 1); 4 graded as mild, 4 moderate, 1 severe, and 1 fatal (due to perforation). A total of 38 (44 %) patients died of disease progression during the study period. The median patient survival was 167 days (95 %CI 112 - 221) days. The 6-month stent patency rate was 95 % (95 %CI 94.94 - 95.06 %) and the 1-year stent patency was 86 % (95 %CI 85.74 - 86.26 %).
This study on EUS-BD demonstrates excellent efficacy and safety of EUS-BD when performed by experts.
NCT01889953.
在内镜逆行胰胆管造影术（ERCP）失败后，内镜超声引导下胆道引流术（EUS-BD）已成为传统放射学和外科引流手术的替代方法。然而，前瞻性多中心数据尚缺乏。本研究的目的是前瞻性评估EUS-BD在恶性远端胆管梗阻患者中的短期和长期疗效及安全性。
来自12个三级中心（5个美国中心、5个欧洲中心、1个亚洲中心、1个南美中心）的连续性恶性远端胆管梗阻且ERCP失败的患者接受了EUS-BD。技术成功定义为将支架成功放置在期望位置。临床成功定义为胆红素在2周时降低50%或在4周时降至3mg/dL以下。前瞻性追踪不良事件并根据美国胃肠内镜学会（ASGE）词汇表的严重程度分级系统进行分级。使用Kaplan-Meier分析计算总生存期和支架通畅持续时间。
共有96例患者（平均年龄66岁，女性45%，胰腺癌55%）接受了EUS-BD。92例（95.8%）患者实现了支架置入（技术成功）（金属支架84例，塑料支架8例）。平均手术时间为40分钟。86例（89.5%）患者取得了临床成功。共发生10例（10.5%）不良事件：气腹（n = 2）、导丝剪断（n = 1）、出血（n = 1）、胆漏（n = 3）、胆管炎（n = 2）和意外穿孔（n = 1）；4例为轻度，4例为中度，1例为重度，1例为致命（因穿孔）。在研究期间，共有38例（44%）患者死于疾病进展。患者的中位生存期为167天（95%CI 112 - 221天）。6个月支架通畅率为95%（95%CI 94.94 - 95.06%），1年支架通畅率为86%（95%CI 85.74 - 86.26%）。
这项关于EUS-BD的研究表明，由专家进行EUS-BD时具有出色的疗效和安全性。
NCT01889953。
