Preliminary results of a new covered biliary metal stent for malignant biliary obstruction

The biliary stents in current use have a tendency to be blocked, so we designed a self-expandable metal stent covered with polyurethane to overcome the risk of tumor ingrowth of uncovered self-expandable metal stents. To evaluate the success and the effectiveness of the new membrane-covered self-expandable metal stent (covered modified Gianturco biliary stent), we studied patients with biliary obstruction caused by biliopancreatic carcinoma.

We retrospectively evaluated 47 patients with malignant biliary obstruction to receive either a newly developed self-expandable metal stent covered with polyurethane (21 cases) or an uncovered metal stent (Strecker stent or Wallstent, 26 cases) by the endoscopic transpapillary route.

The success rate of stent insertion and drainage effect of stent showed no statistical difference in patients with a new membrane-covered self-expandable metal stent compared with those with an uncovered metal stent (90.4% vs. 88.5%, P > 0.05; and 100% vs. 95.6%, P > 0.05, respectively). The median patency of the stent was slightly prolonged in patients with a membrane-covered self-expandable metal stent, but there was no statistical difference between two groups (267 vs. 233 days, P > 0.05). The rate of early complication related to stent insertion showed no significant difference between the two groups. During the follow-up period, stent occlusion due to tumor ingrowth occurred in two patients (10.5%) in the membrane-covered, self-expandable stent group, compared with six patients (26.1%) in the uncovered metal stent group. The membrane-covered metal stent was removed successfully and a polyethylene stent was reinserted in one patient who had developed tumor overgrowth.

A new, membrane-covered, self-expandable metal stent has a tendency towards better long-term patency than the uncovered metal stent, and it can effectively prevent tumor ingrowth into the stent. Also it is possible to remove an occluded membrane-covered stent. However, a case-controlled study, including a larger patient number, and long-term follow-up are needed.