Feasibility of placing a modified fully covered self-expandable metal stent above the papilla to minimize stent-induced bile duct injury in patients with refractory benign biliary strictures (with videos)

BackgroundEndoscopic placement of fully covered self-expandable metal stents (FCSEMS) has been attempted to manage benign biliary strictures, but currently available FCSEMSs may be associated with unintended complications, including de novo strictures, in patients with normal life expectancy.ObjectiveTo evaluate the feasibility of an intraductally placed modified FCSEMS to minimize stent-induced bile duct injury in patients with benign biliary strictures.DesignProspective observational clinical feasibility study.SettingTertiary-care academic center.PatientsThis study involved 21 patients with symptomatic benign biliary strictures in whom conventional endoscopic management failed.InterventionStrictured segments were 15 mm above the ampulla of Vater. The modified FCSEMS has convex margins, a lasso, and an anti-migrating waist on the central portion. Stents were placed entirely above the papilla and removed after 3 to 5 months.Main Outcome MeasurementsSuccess, complications, removability, midterm outcome.ResultsFCSEMSs were successfully placed inside the bile duct in all patients. No episodes of pancreatitis, cholangitis, or sepsis were noted during the stenting period. Stent migration occurred in 4 patients (19.0%), but 3 were asymptomatic during follow-up. All stents were removed successfully with rat-tooth forceps without complications. Post-stenting cholangiograms showed improvement of strictures in 20 of 21 patients, without de novo focal stricture. The clinical success rate was 95.2%, with one recurrent stricture.LimitationsThe small number and lack of comparison with other types of FCSEMSs.ConclusionTemporary intraductal placement of a newly modified FCSEMS effectively improved strictures and prevented potential stent-induced complications in patients with benign biliary strictures. Controlled large-scale trials are needed to confirm the long-term efficacy.