Abstract
Background
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.
Methods
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.
Results
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.
Conclusions
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.
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Disclosures
Dr. Rastislav Kunda is a consultant/speaker for Boston Scientific Corp. and for Olympus Medical. Dr. Manuel Pérez-Miranda is a consultant/speaker for Boston Scientific Corp., Xlumena and Gore. Dr. Alberto Larghi is a consultant/speaker for Cook Medical, Boston Scientific Corp., Covidien and Xlumena. Dr. Uwe Will, Dr. Sebastian Ullrich, Dr. Markus Dollhopf and Dr. Michelle Meier have no conflicts of interest or financial ties to disclose.
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Kunda, R., Pérez-Miranda, M., Will, U. et al. EUS-guided choledochoduodenostomy for malignant distal biliary obstruction using a lumen-apposing fully covered metal stent after failed ERCP. Surg Endosc 30, 5002–5008 (2016). https://doi.org/10.1007/s00464-016-4845-6
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DOI: https://doi.org/10.1007/s00464-016-4845-6