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.
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).


METHODS
Prospective, comparative, randomized trial.


METHODS
Tertiary academic medical centers.


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


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


METHODS
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).


CONCLUSIONS
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.
Digestive Disease Center, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea. yksky001@hanmail.net
Young Koog
YK
Cheon
Hyoung-Chul
HC
Oh
Young Deok
YD
Cho
Tae Yoon
TY
Lee
Chan Sup
CS
Shim
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001653:Bile Ducts, Intrahepatic; D016009:Chi-Square Distribution; D002779:Cholestasis / Q000628:therapy*; D016001:Confidence Intervals; D003251:Constriction, Pathologic / Q000628:therapy; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010865:Pilot Projects; D018583:Pliability; D020959:Polyethylene / Q000009:adverse effects; D011140:Polyurethanes / Q000009:adverse effects; D011475:Prosthesis Failure; D015607:Stents / Q000009:adverse effects*
D011140:Polyurethanes; D020959:Polyethylene