The use of double lasso, fully covered self-expandable metal stents with new "anchoring flap" system in the treatment of benign biliary diseases

BACKGROUND: Many benign biliary diseases (BBD) can be treated with fully covered, self-expandable metal stents (FCSEMS) but stent migration occurs in up to 35.7 %. The aim of this study was to prospectively assess the rate of, safety and effectiveness and stent migration of a new biliary FCSEMS with an anti-migration flap (FCSEMS-AF) in patients with BBD. PATIENTS AND METHODS: This was a prospective study from four Italian referral endoscopy centers of 32 consecutive patients (10 females and 22 males; mean age: 60.1 ± 14.8 years; range: 32-84 years) with BBD who were offered endoscopic placement of a FCSEMS-AF as first-line therapy. RESULTS: Were 24 strictures and 8 leaks. Stent placement was technically successful in 32/32 patients (100 %). Immediate clinical improvement was seen in all 32 patients (100 %). One late stent migration occurred (3.3 %). FCSEMS-AF were removed from 30 of the 32 patients (93.7 %) at a mean (± SD) of 124.4 ± 84.2 days (range: 10-386 days) after placement. All patients remained clinically and biochemically well at 1- and 3-month follow-up. One patient (3.3 %) with a post-laparoscopic cholecystectomy stricture developed distal stent migration at 125 days. CONCLUSION: This new FCSEMS with anti-migration flap seems to be a safe and effective first-line treatment option for patients with BBD.