title: Evaluation of the short- and long-term effectiveness and safety of fully covered self-expandable metal stents for drainage of pancreatic fluid collections: results of a Spanish nationwide registry.
abstract: OBJECTIVE
  Initial reports suggest that fully covered self-expandable metal stents (FCSEMSs) may be better suited for drainage of dense pancreatic fluid collections (PFCs), such as walled-off pancreatic necrosis. The primary aim was to analyze the effectiveness and safety of FCSEMSs for drainage of different types of PFCs in a large cohort. The secondary aim was to investigate which type of FCSEMS is superior.
  
  
  METHODS
  This was a retrospective, noncomparative review of a nationwide database involving all hospitals in Spain performing EUS-guided PFC drainage. From April 2008 to August 2013, all patients undergoing PFC drainage with an FCSEMS were included in a database. The main outcome measurements were technical success, short-term (2 weeks) and long-term (6 months) effectiveness, adverse events, and need for surgery.
  
  
  RESULTS
  The study included 211 patients (pseudocyst/walled-off pancreatic necrosis, 53%/47%). The FCSEMSs used were straight biliary (66%) or lumen-apposing (34%). Technical success was achieved in 97% of patients (95% confidence interval [CI], 93%-99%). Short-term- and long-term clinical success was obtained in 94% (95% CI, 89%-97%) and 85% (95% CI, 79%-89%) of patients, respectively. Adverse events occurred in 21% of patients (95% CI, 16%-27%): infection (11%), bleeding (7%), and stent migration and/or perforation (3%). By multivariate analysis, patient age (>58 years) and previous failed drainage were the most important factors associated with negative outcome.
  
  
  CONCLUSIONS
  An FCSEMS is effective and safe for PFC drainage. Older patients with a history of unsuccessful drainage are more likely to fail EUS-guided drainage. The type of FCSEMS does not seem to influence patient outcome.
authors.affiliation: Endoscopy Unit, Gastroenterology Division, University Hospital Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain; Gastroenterology Division, University Hospital Quirón, Madrid, Spain.
authors.forename: Enrique
authors.initials: E
authors.lastname: Vazquez-Sequeiros
authors.affiliation: Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina, USA.
authors.forename: Todd H
authors.initials: TH
authors.lastname: Baron
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: Gastroenterology Department, Hospital Costa del Sol, Marbella, Spain; Gastroenterology Department, Vithas Xanit Internacional Hospital, Benalmadena, Spain.
authors.forename: Andres
authors.initials: A
authors.lastname: Sánchez-Yagüe
authors.affiliation: Endoscopy Unit, Digestive Disease Department, Hospital Universitari de Bellvitge-Institut d'Investigació Biomèdica de Bellvitge, Barcelona, Spain.
authors.forename: Joan
authors.initials: J
authors.lastname: Gornals
authors.affiliation: Endoscopy Unit, Clinica Girona, Girona, Spain.
authors.forename: Ferran
authors.initials: F
authors.lastname: Gonzalez-Huix
authors.affiliation: Department of Gastroenterology and Hepatology, Hospital Universitario Rio Hortega, Valladolid, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: de la Serna
authors.affiliation: Endoscopy Unit, Gastroenterology Division, University Hospital Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain.
authors.forename: Juan Angel
authors.initials: JA
authors.lastname: Gonzalez Martin
authors.affiliation: Gastroenterology Department, Hospital Universitario de Canarias, San Cristóbal de La Laguna, Spain.
authors.forename: Antonio Z
authors.initials: AZ
authors.lastname: Gimeno-Garcia
authors.affiliation: Gastroenterology Department, Araba University Hospital, Vitoria-Gasteiz, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Marra-Lopez
authors.affiliation: Complejo Hospitalario Universitario Insular Materno Infantil, Gran Canaria, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Castellot
authors.affiliation: Gastroenterology Department, Unidad de Gestión Clínica Digestivo, Hospital Clinico Universitario de la Arrixava, Murcia, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Alberca
authors.affiliation: Department of Gastroenterology, Hospital de Navarra, Pamplona, Spain.
authors.forename: Ignacio
authors.initials: I
authors.lastname: Fernandez-Urien
authors.affiliation: Endoscopy Unit, Hospital General Universitario de Alicante, Alicante, Spain.
authors.forename: Jose Ramon
authors.initials: JR
authors.lastname: Aparicio
authors.affiliation: Gastroenterology Department, Hospital General La Mancha Centro, Alcázar de San Juan, Spain.
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Legaz
authors.affiliation: Endoscopy Unit, Gastroenterology Department, Institute of Digestive and Metabolic Diseases, Hospital Clínic, IDIBAPS, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona, Spain.
authors.forename: Oriol
authors.initials: O
authors.lastname: Sendino
authors.affiliation: Gastroenterology Department, Servei Aparell Digestiu-Unitat d'Endoscòpia, Hospital Universitari Mútua de Terrassa, Terrassa, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Loras
authors.affiliation: Gastroenterology Department, Clínica Universidad de Navarra, Pamplona, Spain.
authors.forename: Jose Carlos
authors.initials: JC
authors.lastname: Subtil
authors.affiliation: Gastroenterology Department, Hospital Clínico Universitario "Lozano Blesa," Zaragoza, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Nerin
authors.affiliation: Endoscopy Unit, Gastroenterology Department, Servicio de Medicina de Aparato Digestivo, Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Perez-Carreras
authors.affiliation: Endoscopy Unit, Gastroenterology Department, Servicio de Medicina de Aparato Digestivo, Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: Jose
authors.initials: J
authors.lastname: Diaz-Tasende
authors.affiliation: Endoscopy Unit, Gastroenterology Department, Hospital Universitario Central de Asturias, Oviedo, Spain.
authors.forename: Gustavo
authors.initials: G
authors.lastname: Perez
authors.affiliation: Endoscopy Unit, Gastroenterology Department, Hospital Virgen de la Salud, Toledo, Spain.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Repiso
authors.affiliation: Endoscopy Unit, Gastroenterology Department. Hospital Son Llatzer, Palma de Mallorca, Spain.
authors.forename: Angels
authors.initials: A
authors.lastname: Vilella
authors.affiliation: Endoscopy Unit, Gastroenterology Department. Hospital Son Llatzer, Palma de Mallorca, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Dolz
authors.affiliation: Gastroenterology Department, Complejo Asistencial Universitario de Salamanca, Salamanca, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Alvarez
authors.affiliation: Gastroenterology Department, Complejo Asistencial Universitario de Zamora, Zamora, Spain.
authors.forename: Santiago
authors.initials: S
authors.lastname: Rodriguez
authors.affiliation: Endoscopy Unit, Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: Jose Miguel
authors.initials: JM
authors.lastname: Esteban
authors.affiliation: Gastroenterology Division, University Hospital Quirón, Madrid, Spain.
authors.forename: Diego
authors.initials: D
authors.lastname: Juzgado
authors.affiliation: Endoscopy Unit, Gastroenterology Division, University Hospital Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain.
authors.forename: Agustin
authors.initials: A
authors.lastname: Albillos
mesh_terms: D000368:Aged; D016208:Databases, Factual; D013505:Digestive System Surgical Procedures / Q000295:instrumentation / Q000379:methods; D004322:Drainage / Q000295:instrumentation* / Q000379:methods; D019160:Endosonography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009336:Necrosis; D010179:Pancreas / Q000473:pathology / Q000601:surgery*; D010192:Pancreatic Pseudocyst / Q000601:surgery*; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D000069322:Self Expandable Metallic Stents; D013030:Spain; D025321:Surgery, Computer-Assisted / Q000295:instrumentation / Q000379:methods; D016896:Treatment Outcome