Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction

Lancet. 1992 Dec;340(8834-8835):1488-92. doi: 10.1016/0140-6736(92)92752-2.


Self-expanding metal stents are claimed to prolong biliary-stent patency, although no formal comparative trial between plastic and expandable stents has been done. In a prospective randomised trial, we assigned 105 patients with irresectable distal bile-duct malignancy to receive either a metal stent (49) or a straight polyethylene stent (56). Median patency of the first stent was significantly prolonged in patients with a metal stent compared with those with a polyethylene stent (273 vs 126 days; p = 0.006). The major cause of stent dysfunction was tumour ingrowth in the metal-stent group and sludge deposition in the polyethylene-stent group. Treatment after any occlusion included placement of a polyethylene stent. In the metal-stent group none of 14 second stents occluded, whereas 11 of 23 (48%) second stents clogged in the polyethylene-stent group (p = 0.002). Overall median survival was 149 days and did not differ significantly between treatment groups. Incremental cost-effectiveness analysis showed that initial placement of a metal stent results in a 28% decrease of endoscopic procedures. Self-expanding metal stents have a longer patency than polyethylene stents and offer adequate palliation in patients with irresectable malignant distal bile-duct obstruction.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Bile Duct Neoplasms / complications*
  • Bile Duct Neoplasms / mortality
  • Cholangiopancreatography, Endoscopic Retrograde
  • Cholestasis / diagnosis
  • Cholestasis / etiology
  • Cholestasis / surgery*
  • Common Bile Duct
  • Cost-Benefit Analysis
  • Female
  • Humans
  • Male
  • Metals
  • Middle Aged
  • Palliative Care
  • Polyethylenes
  • Prospective Studies
  • Stents* / adverse effects
  • Stents* / economics
  • Survival Rate


  • Metals
  • Polyethylenes