A fully covered self-expandable metal stent with antimigration features for benign biliary strictures: a prospective, multicenter cohort study

Abstract

Background: Self-expandable metal stents (SEMSs) are increasingly used for the treatment of benign biliary strictures (BBSs). A new fully covered SEMS (FCSEMS) with flared ends and high conformability was designed to prevent migration of the stent.

Objective: To evaluate the efficacy of a novel FCSEMS with antimigration features.

Design: Prospective cohort study.

Setting: Five hospitals in the Netherlands and Belgium.

Patients: Consecutive patients with BBS.

Intervention: FCSEMS placement for 3 months.

Main outcome measurements: Initial and long term clinical success, stent migration rate and safety.

Results: Thirty-eight patients (24 men; mean age, 53 ± 16 years) were included. Stent placement was technically successful in 37 patients (97%). Two patients died of an unrelated cause before stent removal, and no data on these patients were available on stricture resolution. Initial clinical success was achieved in 28 of 35 patients (80%). During follow-up after stent removal, a symptomatic recurrent stricture developed in 6 of 28 patients (21%). Overall, the long-term clinical success rate was 63% (22 of 35 patients). Stent migration occurred in 11 of 35 patients (31%), including 5 symptomatic (14%) and 6 asymptomatic (17%) migrations. In total, 11 serious adverse events occurred in 10 patients (29%), with cholangitis (n = 5) being most common.

Limitations: Nonrandomized study design.

Conclusions: Good initial clinical success was achieved after placement of this novel FCSEMS, but stricture recurrence was in the upper range compared with other FCSEMSs. The antimigration design could not prevent migration in a significant number of patients with a persisting stricture.