New 10F soft and pliable polyurethane stents decrease the migration rate compared with conventional 10F polyethylene stents in hilar biliary obstruction: results of a pilot study

Abstract

Background: Migration of biliary stents is a well-documented problem that can result in a variety of complications. The newly designed polyurethane (PU) stent, which is made of a soft and pliable material, may prevent distal and proximal stent migration.

Objective: To compare the migration rate of the PU stent with that of the conventional polyethylene stent (PE).

Design: Prospective, comparative, randomized trial.

Setting: Tertiary academic medical centers.

Patients: Fifty patients with a hilar stricture who had not undergone a previous drainage procedure.

Intervention: In patients with hilar stricture, random assignment of either a PU stent or PE stent.

Main outcome measurement: The rate of early proximal or distal migration before stent occlusion.

Results: Overall and distal migration rates were significantly lower in the PU group than in the PE group (4.5% vs 29%, P = .032 and 4.5% vs 26.1%, P = .049, respectively). There was no significant difference between the migration rate in benign and malignant biliary strictures (5.9% vs 21.4%, P = .167). Sex, stent length, preprocedure bilirubin level, and Bismuth type were not associated with migration rate in either the PU or PE group. Median stent patency was 148 days (range 36-224 days) in the PU group and 151 days (range 40-241 days) in the PE group (P = .891).

Limitations: Small sample size.

Conclusions: Use of the new PU stent, which is soft and pliable, decreased distal migration. The PU stent patency rates appear similar, but this study is not powered to demonstrate equivalency of patency.