Abstract
Background and study aims Stent insertion at endoscopic retrograde cholangiopancreatography (ERCP) is an established
therapy for managing malignant biliary obstruction. Conventional plastic stents with
a tubular design are most commonly used despite limited patency. Plastic stents with
a winged design may theoretically increase the duration of stent patency. The aim
of this study was to compare stent patency of the winged versus conventional plastic
stents in patients with malignant biliary obstruction.
Patients and methods A prospective, randomized subject-blinded trial was conducted. Patients with malignant
biliary obstruction were randomized (1:1) to either a 10 French winged stent or 7
or 10 French conventional plastic stent. Strictures greater than 1 cm distal to the
hilum were included. Patients were followed clinically to determine the frequency
of stent failure until surgery, death or study closure.
Results Fifty-eight patients were enrolled. Following 9 exclusions, 49 patients were randomized
to a winged (n = 23) or conventional stent (n = 26). Median time to stent failure
was 89 (95 % CI 26-NA) vs 143 (95 % CI 33 – 266) days (P = 0.963) for the winged and conventional group, respectively. Stent failure for the
winged group occurred in 11 (48 %) compared to 14 (54 %) in the conventional group. Median
survival was 123 (95 % CI 81 – 189) vs 342 days (95 % CI 123 – 704) (p = 0.084) in
the winged and conventional group respectively. There were no procedure related adverse
events.
Conclusions Improvement in stent patency was not seen with the winged stent when compared to the
conventional plastic stent.
Clinical trials number NCT01514214.
