Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial.

This prospective and randomized trial sought to compare large-bore plastic endoprostheses (14 French) and self-expanding metal stents (24 French) in the palliative treatment of obstructive jaundice due to biliary hilar malignancies. Twenty patients with Type II-IV (Bismuth classification) hilar obstruction were randomized to treatment with either plastic or metal stents. Both treatment groups were well matched with regard to all assessed clinical criteria before stenting. Stent placement was uniformly successful in the metal group and in 88.9% of the plastic group. Early stent failure (< 30 days) occurred in two patients of the plastic stent group. Longterm (> 30 days), stent failure was observed in 50% of the plastic group and 18.2% of the metal stent group. All differences were not statistically significant. The number of re-interventions required to manage stent-related problems proved to be significantly higher in the plastic group (2.4 +/- 2.6) compared to the metal group (0.4 +/- 0.5). Hospitalization for treatment of stent complications was also significantly higher in the plastic treatment group. The costs calculated for stents and hospital stay for required re-interventions were therefore higher in the plastic stent group. In conclusion, metal stent insertion for palliation of hilar malignancies does not only offer higher success rates and higher patency rates compared to plastic stent insertion, but is also cost-effective since patients require fewer re-interventions.

RCT Entities:   Population Interventions Outcomes