Endoscopic palliation with biliary endoprostheses is now an established treatment for benign and malignant strictures of the biliary tree. These endoprostheses, however, tend to clog with time. We investigated this problem by undertaking in vitro studies on stents of different designs made of different polymer materials. The stent that performed best was then tested in an in vivo trial. There was a direct relation in vitro between the frictional coefficient of a polymer and the amount of encrusted material. Catheters perfused in bacterially contaminated bile, irrespective of material and design, accrued significantly more sludge than catheters perfused with sterilised bile. The presence of side holes significantly increased the amount of sludge in the stents, but eliminated any differences between the various materials. We therefore investigated the effect of omitting side holes in a clinical trial which consisted of two groups of 20 patients each. The group treated with conventional stents accrued significantly more sludge in the stents than the group treated with experimental stents without side holes (p less than 0.05). The absence of side holes did not cause incomplete drainage or increase morbidity. Side holes are detrimental to stent patency, which is adversely affected by other factors including bacteria and proteins.
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