Rastislav Kunda1, Manuel Pérez-Miranda2, Uwe Will3, Sebastian Ullrich4, Dirk Brenke5, Markus Dollhopf6, Michelle Meier7, Alberto Larghi8. 1. Department of Surgical Gastroenterology L, Aarhus University Hospital, Noerrebrogade 44, 8000, Aarhus C, Denmark. rasti.kunda@aarhus.rm.dk. 2. Department of Gastroenterology and Hepatology, Hospital Universitario Rio Hortega, Valladolid, Spain. 3. Department of Gastroenterology, Municipal Hospital, Gera, Germany. 4. Department of Internal Medicine I, Asklepios Klinik Altona, Hamburg, Germany. 5. Department of Gastroenterology, Städtisches Klinikum, Karlsruhe, Germany. 6. Department of Gastroenterology, Klinikum Neuperlach, Munich, Germany. 7. Department of Surgical Gastroenterology L, Aarhus University Hospital, Noerrebrogade 44, 8000, Aarhus C, Denmark. 8. Digestive Endoscopy Unit, Catholic University, Rome, Italy.
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.
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.
Authors: Raj J Shah; Janak N Shah; Irving Waxman; Thomas E Kowalski; Andres Sanchez-Yague; Jose Nieto; Brian C Brauer; Monica Gaidhane; Michel Kahaleh Journal: Clin Gastroenterol Hepatol Date: 2014-10-05 Impact factor: 11.382
Authors: Everson L A Artifon; Fernando P Marson; Monica Gaidhane; Michel Kahaleh; Jose P Otoch Journal: Gastrointest Endosc Date: 2014-12-12 Impact factor: 9.427
Authors: Michel Kahaleh; Everson L A Artifon; Manuel Perez-Miranda; Kapil Gupta; Takao Itoi; Kenneth F Binmoeller; Marc Giovannini Journal: World J Gastroenterol Date: 2013-03-07 Impact factor: 5.742
Authors: Do Hyun Park; Seung Uk Jeong; Byung Uk Lee; Sang Soo Lee; Dong-Wan Seo; Sung Koo Lee; Myung-Hwan Kim Journal: Gastrointest Endosc Date: 2013-03-21 Impact factor: 9.427
Authors: Abdul H El Chafic; Janak N Shah; Chris Hamerski; Kenneth F Binmoeller; Shayan Irani; Theodore W James; Todd H Baron; Jose Nieto; Ricardo V Romero; John A Evans; Michel Kahaleh Journal: Dig Dis Sci Date: 2019-06-07 Impact factor: 3.199
Authors: A Hedjoudje; A Sportes; S Grabar; A Zhang; S Koch; L Vuitton; F Prat Journal: United European Gastroenterol J Date: 2018-10-26 Impact factor: 4.623
Authors: Nuno Nunes; Margarida Flor de Lima; Ana Caldeira; Sílvia Leite; Susana Marques; Teresa Moreira; Pedro Moutinho-Ribeiro; Miguel Bispo Journal: GE Port J Gastroenterol Date: 2020-09-25
Authors: Benedetto Mangiavillano; Jong Ho Moon; Antonio Facciorusso; Francesco Di Matteo; Danilo Paduano; Milutin Bulajic; Andrew Ofosu; Francesco Auriemma; Laura Lamonaca; Hae Won Yoo; Roberta Rea; Marco Massidda; Alessandro Repici Journal: Endosc Int Open Date: 2022-07-15