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 obstruction.METHODS:Multicenter prospective r...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 obstruction.METHODS:Multicenter prospective randomized clinical trial with treatment allocation to a pcWallstent(SEMS)or a 10 French PS.Palliative patients aged≥18,for infrahilar malignant biliary obstruction and a Karnofsky performance scale index>60%from 6 participating North American university centers.Primary 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 years.Survival analyses were performed for stent failure and death,with Cox proportional hazards regression models to determine significant predictive characteristics.RESULTS:Eighty-five patients were accrued over 37mo,42 were randomized to the SEMS group and 83patients were available for analyses.Time to stent failure was 385.3±52.5 d in the SEMS and 153.3±19.8 d in the PS group,P=0.006.Time 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 life.From an initially planned 120 patients,only 85 patients were recruited.CONCLUSION: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.展开更多
基金Supported by Research Funding from Boston Scientific Inc to Barkun ANResearch Funding from Cook Endoscopy to Branch MSResearch Funding from Pentax Corp to Kowalski TE
文摘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 obstruction.METHODS:Multicenter prospective randomized clinical trial with treatment allocation to a pcWallstent(SEMS)or a 10 French PS.Palliative patients aged≥18,for infrahilar malignant biliary obstruction and a Karnofsky performance scale index>60%from 6 participating North American university centers.Primary 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 years.Survival analyses were performed for stent failure and death,with Cox proportional hazards regression models to determine significant predictive characteristics.RESULTS:Eighty-five patients were accrued over 37mo,42 were randomized to the SEMS group and 83patients were available for analyses.Time to stent failure was 385.3±52.5 d in the SEMS and 153.3±19.8 d in the PS group,P=0.006.Time 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 life.From an initially planned 120 patients,only 85 patients were recruited.CONCLUSION: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.
