EUS-guided choledochoduodenostomy for malignant distal biliary obstruction using a lumen-apposing fully covered metal stent after failed ERCP

A novel lumen-apposing, self-expanding metal stent to perform EUS-guided drainage procedures has been recently developed. The aim of this study was to analyze the safety, technical and clinical effectiveness of this device for EUS-guided choledochoduodenostomy (EUS-CD) with palliative intent. Retrospective analysis of all consecutive patients with unresectable malignant distal bile duct obstruction who, between March 2012 and September 2014, underwent EUS-CD using the study devices (AXIOS (TM) and Hot AXIOS (TM), Xlumena Inc., Mountain View, CA, USA) after unsuccessful ERCP in seven European centers was carried out. Fifty-seven patients (M/F 31/26; median age 73) underwent EUS-CD using the AXIOS (TM) stent or the Hot AXIOS (TM) delivery system. ERCP failure was due to duodenal obstruction in 41 patients (71.9 %) and to inability to cannulate the papilla in the remaining 16 patients (28.1 %). The procedure was technically successful in 56/57 patients (98.2 %), with a mean procedural time of 22.4 min (range 11-65). Clinical success was achieved in 54 of these 56 patients (96.4 %; 94.7 % of the entire cohort). Overall major procedural complication rate was 7 % (two duodenal perforations, one bleeding and one transient cholangitis). During follow-up, 5 out of 54 (9.3 %) patients with clinica success required re-intervention for stent migration in one case and a sump syndrome with transient increase in serum bilirubin concentrations with sludge in the distal duct reservoir in the remaining four patients. Our study shows that EUS-CD using the AXIOS (TM) and the Hot AXIOS (TM) devices is a safe procedure, with high technical and clinical success rates.