Published online Dec 14, 2013. doi: 10.3748/wjg.v19.i46.8638
Revised: July 17, 2013
Accepted: September 4, 2013
Published online: December 14, 2013
AIM: To compare efficacy and complications of partially 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 37 mo, 42 were randomized to the SEMS group and 83 patients 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 vs 211.5 ± 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.
Core tip: This randomized trial is one of very few comparing partially covered self-expandable metal stent (SEMS) to 10 French plastic stent (PS) in the contemporary palliation of malignant biliary obstruction. In 85 patients, time to stent failure was significantly longer (385.3 ± 52.5 d) in SEMS vs PS (153.3 ± 19.8 d), P = 0.006. Time to death did not differ (192.3 ± 23.4 d for SEMS vs 211.5 ± 28.0 d for PS, P = 0.70). Amongst other measured outcomes, only cholangitis differed and was more common in PS (4.9% vs 24.5%, P = 0.029).