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)

Background Endoscopic 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. Objective To evaluate the feasibility of an intraductally placed modified FCSEMS to minimize stent-induced bile duct injury in patients with benign biliary strictures. Design Prospective observational clinical feasibility study. Setting Tertiary-care academic center. Patients This study involved 21 patients with symptomatic benign biliary strictures in whom conventional endoscopic management failed. Intervention Strictured 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 Measurements Success, complications, removability, midterm outcome. Results FCSEMSs 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. Limitations The small number and lack of comparison with other types of FCSEMSs. Conclusion Temporary 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.