Randomized trial in malignant biliary obstruction:Plastic vs partially covered metal stents

作     者：Peter L Moses Khalid M AlNaamani Alan N Barkun Stuart R Gordon Roger D Mitty M Stanley Branch Thomas E Kowalski Myriam Martel Viviane Adam 

作者机构：Division of Gastroenterology and Hepatology University of Vermont Division of Gastroenterology McGill University Health Center McGill University Department of Epidemiology and Biostatistics and Occupational Health McGill University Health Center Division of Gastroenterology and Hepatology Dartmouth Hitchcock Medical Center Lebanon Division of Gastroenterology Tufts University School of Medicine Boston Division of Gastroenterology Duke University Medical Center Durham Division of Gastroenterology and Hepatology Thomas Jefferson University Hospital 

出 版 物：《World Journal of Gastroenterology》 (世界胃肠病学杂志（英文版）)

年 卷 期：2013年第19卷第46期

页      面：8638-8646页

核心收录：

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

基　　金：Supported by Research Funding from Boston Scientific Inc to Barkun AN Research Funding from Cook Endoscopy to Branch MS Research Funding from Pentax Corp to Kowalski TE 

主　　题：Randomized Biliary Obstruction Stent Plastic Metal Palliative Common bile duct 

摘      要：AIM:To compare efficacy and complications of par-tially covered self-expandable metal stent(pcSEMS)to plastic stent(PS)in patients treated for malignant,infrahilar biliary ***:Multicenter prospective randomized clinical trial with treatment allocation to a pcWallstent(SEMS)or a 10 French *** patients aged≥18,for infrahilar malignant biliary obstruction and a Karnofsky performance scale index60%from 6 participating North American university *** endpoint was time to stent failure,with secondary outcomes of death,adverse events,Karnofsky performance score and short-form-36 scale administered on a three-monthly basis for up to 2 *** analyses were performed for stent failure and death,with Cox proportional hazards regression models to determine significant predictive ***:Eighty-five patients were accrued over 37mo,42 were randomized to the SEMS group and 83patients were available for *** to stent failure was 385.3±52.5 d in the SEMS and 153.3±19.8 d in the PS group,P=*** to death did not differ between groups(192.3±23.4 d for SEMS vs211.5±28.0 d for PS,P=0.70).The only significant predictor was treatment allocation,relating to the time to stent failure(P=0.01).Amongst other measured outcomes,only cholangitis differed,being more common in the PS group(4.9%vs 24.5%,P=0.029).The small number of patients in follow-up limits longitudinal assessments of performance and quality of *** an initially planned 120 patients,only 85 patients were ***:Partially covered SEMS result in a longer duration till stent failure without increased complication rates,yet without accompanying measurable benefits in survival,performance,or quality of life.