EUS-guided choledochoduodenostomy for malignant distal biliary obstruction using a lumen-apposing fully covered metal stent after failed ERCP
- 991 Downloads
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.
KeywordsEUS-guided biliary drainage Failed ERCP choledochoduodenostomy SEMSs Interventional EUS
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.
- 1.Halttunen J, Meisner S, Aabakken L, Arnelo U, Grönroos J, Hauge T, Kleveland PM, Nordblad Schmidt P, Saarela A, Swahn F, Toth E, Mustonen H, Löhr JM (2014) Difficult cannulation as defined by a prospective study of Scandinavian Association for Digestive Endoscopy (SADE) in 907 ERCPs. Scand J Gastroenterol 49:752–758CrossRefPubMedGoogle Scholar
- 8.Gupta K, Perez-Miranda M, Kahaleh M, Artifon EL, Itoi T, Freeman ML, de Serna C, Sauer B, Giovannini M, In EBD STUDY GROUP (2014) Endoscopic ultrasound-assisted bile duct access and drainage: multicenter, long-term analysis of approach, outcomes, and complications of a technique in evolution. J Clin Gastroenterol 48:80–87CrossRefPubMedGoogle Scholar
- 11.Itoi T, Binmoeller KF, Shah J, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Moriyasu F (2012) Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc 75:870–876CrossRefPubMedGoogle Scholar
- 13.Walter D, Will U, Sanchez-Yague A, Brenke D, Hampe J, Wollny H, López-Jamar JM, Jechart G, Vilmann P, Gornals JB, Ullrich S, Fähndrich M, de Tejada AH, Junquera F, Gonzalez-Huix F, Siersema PD, Vleggaar FP (2015) A novel lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic fluid collections: a prospective cohort study. Endoscopy 47:63–67CrossRefPubMedGoogle Scholar
- 15.Shah RJ, Shah JN, Waxman I, Kowalski TE, Sanchez-Yague A, Nieto J, Brauer BC, Gaidhane M, Kahaleh M (2015) Safety and efficacy of endoscopic ultrasound-guided drainage of pancreatic fluid collections with lumen-apposing covered self-expanding metal stents. Clin Gastroenterol Hepatol 13:747–752CrossRefPubMedGoogle Scholar
- 16.Rinninella E, Kunda R, Dollhopf M, Sanchez-Yague A, Will U, Tarantino I, Gornals Soler J, Ullrich S, Meining A, Esteban JM, Enz T, Vanbiervliet G, Vleggaar F, Attili F, Larghi A (2015) EUS-guided drainage of pancreatic fluid collections using a novel lumen-apposing metal stent on an electrocautery enhanced delivery system: a large retrospective study. Gastrointest Endosc 82:1039–1046CrossRefPubMedGoogle Scholar
- 20.Artifon EL, Aparicio D, Paione JB, Lo SK, Bordini A, Rabello C, Otoch JP, Gupta K (2012) Biliary drainage in patients with unresectable, malignant obstruction where ERCP fails: endoscopic ultrasonography-guided choledochoduodenostomy versus percutaneous drainage. J Clin Gastroenterol 46:768–774CrossRefPubMedGoogle Scholar
- 21.Khashab MA, Valeshabad AK, Afghani E, Singh VK, Kumbhari V, Messallam A, Saxena P, El Zein M, Lennon AM, Canto MI, Kalloo AN (2015) A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP. Dig Dis Sci 60:557–565CrossRefPubMedGoogle Scholar
- 27.Khashab MA, Valeshabad AK, Modayil R, Widmer J, Saxena P, Idrees M, Iqbal S, Kalloo AN, Stavropoulos SN (2013) EUS-guided biliary drainage by using a standardized approach for malignant biliary obstruction: rendezvous versus direct transluminal techniques (with videos). Gastrointest Endosc 78:734–741CrossRefPubMedGoogle Scholar