title: A novel lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic fluid collections: a prospective cohort study.
abstract: OBJECTIVE
  A novel large-diameter, lumen-apposing, self-expanding metal stent with bilateral flanges was recently developed for endoscopic ultrasound (EUS)-guided transmural drainage of symptomatic pancreatic fluid collections (PFCs). The aim of this study was to evaluate the efficacy and safety of this stent in a large cohort.
  
  
  METHODS
  Patients with a PFC undergoing EUS-guided drainage with this novel stent were prospectively enrolled in this multicenter cohort study.
  
  
  RESULTS
  There were 61 patients: 46 patients (75 %) with walled-off necrosis (WON) and 15 (25 %) with a pancreatic pseudocyst. Stent placement was technically successful in 60 patients (98 %, 95 %CI 95 % - 100 %). Clinical success, defined as resolution of clinical symptoms in combination with a decrease in the PFC size to ≤ 2 cm on imaging, was achieved in 93 % of patients with a pancreatic pseudocyst (95 %CI 77 % - 100 %) and in 81 % of patients with WON (95 %CI 69 % - 94 %). Treatment failure occurred in nine patients (16 %, 95 %CI 6 % - 26 %), including four patients who required surgical intervention. Stent removal was performed in 82 % of patients after a median of 32 days (range 2 - 178) and was rated as easy in all but one patient. In 10 patients, endoscopic stent removal was not performed because of stent migration (n = 3), stent dislodgement during necrosectomy (n = 3), stent removal during surgery (n = 2), or refusal by the patient (n = 2). In total, five major complications were reported (9 %, 95 %CI 2 % - 16 %), including PFC infection (n = 4) and perforation (n = 1).
  
  
  CONCLUSIONS
  EUS-guided drainage using this novel stent is feasible and the clinical results obtained are promising with a low major complication rate.
authors.affiliation: Department Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, Netherlands.
authors.forename: Daisy
authors.initials: D
authors.lastname: Walter
authors.affiliation: Department of Gastroenterology, Municipal Hospital, Gera, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Will
authors.affiliation: Endoscopy Unit, Hospital Costa del Sol, Marbella, Spain.
authors.forename: Andres
authors.initials: A
authors.lastname: Sanchez-Yague
authors.affiliation: Department of Internal Medicine II, Department of Gastroenterology, Städt. Klinikum Karlsruhe, Karlsruhe, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Brenke
authors.affiliation: Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Dresden, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Hampe
authors.affiliation: Department of Internal Medicine and Gastroenterology, Medical Center Städte Region Aachen, Würselen, Germany.
authors.forename: Helge
authors.initials: H
authors.lastname: Wollny
authors.affiliation: Department of Endoscopy, Hospital Clinico San Carlos, Madrid, Spain.
authors.forename: Jose Miguel Esteban
authors.initials: JM
authors.lastname: López-Jamar
authors.affiliation: Department of Gastroenterology, Klinikum Augsburg, Augsburg, Germany.
authors.forename: Gertrud
authors.initials: G
authors.lastname: Jechart
authors.affiliation: Department of Surgery, Copenhagen University Hospital Herlev, Copenhagen, Denmark.
authors.forename: Peter
authors.initials: P
authors.lastname: Vilmann
authors.affiliation: Department of Endoscopy, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, Spain.
authors.forename: Joan B
authors.initials: JB
authors.lastname: Gornals
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 Interventional Endoscopy, Klinikum Dortmund, University Münster, Dortmund, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Fähndrich
authors.affiliation: Department of Gastroenterology, IDIPHIM, Puerta de Hierro University Hospital, Autónoma University, Madrid, Spain.
authors.forename: Alberto Herreros
authors.initials: AH
authors.lastname: de Tejada
authors.affiliation: Department of Digestive Disease, Hospital Parc Tauli, Barcelona, Spain.
authors.forename: Félix
authors.initials: F
authors.lastname: Junquera
authors.affiliation: Endoscopy Unit, Clinica Girona, Girona, Spain.
authors.forename: Ferran
authors.initials: F
authors.lastname: Gonzalez-Huix
authors.affiliation: Department Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, Netherlands.
authors.forename: Peter D
authors.initials: PD
authors.lastname: Siersema
authors.affiliation: Department Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, Netherlands.
authors.forename: Frank P
authors.initials: FP
authors.lastname: Vleggaar
mesh_terms: D000328:Adult; D000368:Aged; D004322:Drainage / Q000295:instrumentation / Q000379:methods*; D019160:Endosonography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010192:Pancreatic Pseudocyst / Q000000981:diagnostic imaging / Q000628:therapy*; D019283:Pancreatitis, Acute Necrotizing / Q000000981:diagnostic imaging / Q000628:therapy*; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional