RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction
Secondary outcome measures (compare above) are complications caused by the stent or stent
insertion and technical ease to insert the stent. To discover a 10% difference between the 2
groups, regarding patency, 400 patients must be included in the trial, alfa 0.05, beta 0.8.
We know from previous trials (Single center trial South Hospital GIE 2006;63:986-995 and a
newly finished similar swedish multicenter trial,prel data DDW- 09)that the 9 hospitals
recruited will be able to include this no of patients in approximately 2.5 years.
We will have a shortest follow-up period of 10 months, followup will be by phone with
standard questions connected to stent failure, which is defined clinically AND by a new ERCP
with intervention because of an obstructed stent.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
10 months follow up
Claes soderlund, assist prof
south hospital, stockholm sweden
Sweden: Regional Ethical Review Board
Steel vs nitinol