title: EUS-guided choledochoduodenostomy for malignant distal biliary obstruction using a lumen-apposing fully covered metal stent after failed ERCP.
abstract: 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™ and Hot AXIOS™, 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™ stent or the Hot AXIOS™ 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™ and the Hot AXIOS™ devices is a safe procedure, with high technical and clinical success rates.
authors.affiliation: Department of Surgical Gastroenterology L, Aarhus University Hospital, Noerrebrogade 44, 8000, Aarhus C, Denmark. rasti.kunda@aarhus.rm.dk.
authors.forename: Rastislav
authors.initials: R
authors.lastname: Kunda
authors.affiliation: Department of Gastroenterology and Hepatology, Hospital Universitario Rio Hortega, Valladolid, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Pérez-Miranda
authors.affiliation: Department of Gastroenterology, Municipal Hospital, Gera, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Will
authors.affiliation: Department of Internal Medicine I, Asklepios Klinik Altona, Hamburg, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Ullrich
authors.affiliation: Department of Gastroenterology, Städtisches Klinikum, Karlsruhe, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Brenke
authors.affiliation: Department of Gastroenterology, Klinikum Neuperlach, Munich, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Dollhopf
authors.affiliation: Department of Surgical Gastroenterology L, Aarhus University Hospital, Noerrebrogade 44, 8000, Aarhus C, Denmark.
authors.forename: Michelle
authors.initials: M
authors.lastname: Meier
authors.affiliation: Digestive Endoscopy Unit, Catholic University, Rome, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Larghi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects; D002768:Choledochostomy; D002779:Cholestasis / Q000209:etiology / Q000628:therapy*; D020099:Coated Materials, Biocompatible; D004106:Dilatation; D004322:Drainage / Q000379:methods; D019160:Endosonography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications; D012189:Retrospective Studies; D015607:Stents; D018084:Ultrasonography, Interventional
chemical_list: D020099:Coated Materials, Biocompatible
keywords: EUS-guided biliary drainage; Failed ERCP; Interventional EUS; SEMSs; choledochoduodenostomy