title: A US Multicenter Study of Safety and Efficacy of Fully Covered Self-Expandable Metallic Stents in Benign Extrahepatic Biliary Strictures.
abstract: BACKGROUND
  Endoscopic therapy is considered first line for management of benign biliary strictures (BBSs). Placement of plastic stents has been effective but limited by their short-term patency and need for repeated procedures. Fully covered self-expandable metallic stents (FCSEMSs) offer longer-lasting biliary drainage without the need for frequent exchanges.
  
  
  OBJECTIVE
  The aim of this study was to assess the efficacy and safety of FCSEMS in patients with BBS.
  
  
  METHODS
  A retrospective review of all patients who underwent ERCP and FCSEMS placement at five tertiary referral US hospitals was performed. Stricture resolution and adverse events related to ERCP and/or stenting were recorded.
  
  
  RESULTS
  A total of 123 patients underwent FCSEMS placement for BBS and 112 underwent a subsequent follow-up ERCP. The mean age was 62 years (±15.6), and 57% were males. Stricture resolution occurred in 81% of patients after a mean of 1.2 stenting procedures (mean stent dwell time 24.4 ± 2.3 weeks), with a mean follow-up of 18.5 months. Stricture recurrence occurred in 5 patients, and 3 patients required surgery for treatment of refractory strictures. Stent migration (9.7%) was the most common complication, followed by stent occlusion (4.9%), cholangitis (4.1%), and pancreatitis (3.3%). There was one case of stent fracture during removal, and one stent could not be removed. There was one death due to cholangitis.
  
  
  CONCLUSIONS
  Majority of BBS can be successfully managed with 1-2 consecutive FCSEMS with stent dwell time of 6 months.
authors: Division of Gastroenterology and Hepatology, Department of Medicine, The Johns Hopkins Medical Institutions, Baltimore, MD, USA. psaxena1@jhmi.edu.|Lifehouse at Royal Prince Alfred Hospital, 119 Missenden Rd, Campberdown, NSW, 2050, Australia. psaxena1@jhmi.edu.
authors: Payal
authors: P
authors: Saxena
authors: Division of Gastroenterology and Hepatology, Department of Medicine, Geisinger Health System, Danville, PA, USA.
authors: David L
authors: DL
authors: Diehl
authors: Division of Gastroenterology and Hepatology, Department of Medicine, The Johns Hopkins Medical Institutions, Baltimore, MD, USA.
authors: Vivek
authors: V
authors: Kumbhari
authors: Division of Gastroenterology and Hepatology, Department of Medicine, Geisinger Health System, Danville, PA, USA.
authors: Frederick
authors: F
authors: Shieh
authors: Division of Gastroenterology and Hepatology, Department of Medicine, Stony Brook University Medical Center, Stony Brook, NY, USA.
authors: Jonathan M
authors: JM
authors: Buscaglia
authors: Division of Gastroenterology and Hepatology, Department of Medicine, Stony Brook University Medical Center, Stony Brook, NY, USA.
authors: Wilson
authors: W
authors: Sze
authors: Division of Gastroenterology and Hepatology, Department of Medicine, Stony Brook University Medical Center, Stony Brook, NY, USA.
authors: Sumit
authors: S
authors: Kapoor
authors: Division of Gastroenterology and Hepatology, Department of Medicine, Northwestern University, Chicago, IL, USA.
authors: Srinadh
authors: S
authors: Komanduri
authors: Division of Gastroenterology and Hepatology, Department of Medicine, University of Pittsburg Medical Center, Pittsburg, PA, USA.
authors: John
authors: J
authors: Nasr
authors: Division of Gastroenterology and Hepatology, Department of Medicine, The Johns Hopkins Medical Institutions, Baltimore, MD, USA.
authors: Eun Ji
authors: EJ
authors: Shin
authors: Division of Gastroenterology and Hepatology, Department of Medicine, The Johns Hopkins Medical Institutions, Baltimore, MD, USA.
authors: Vikesh
authors: V
authors: Singh
authors: Division of Gastroenterology and Hepatology, Department of Medicine, The Johns Hopkins Medical Institutions, Baltimore, MD, USA.
authors: Anne Marie
authors: AM
authors: Lennon
authors: Division of Gastroenterology and Hepatology, Department of Medicine, The Johns Hopkins Medical Institutions, Baltimore, MD, USA.
authors: Anthony N
authors: AN
authors: Kalloo
authors: Division of Gastroenterology and Hepatology, Department of Medicine, The Johns Hopkins Medical Institutions, Baltimore, MD, USA.|Johns Hopkins Hospital, 1800 Orleans St, Suite 7125B, Baltimore, MD, 21205, USA.
authors: Mouen A
authors: MA
authors: Khashab
mesh_terms: D000368:Aged; D017734:Bile Ducts, Extrahepatic; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002761:Cholangitis / Q000209:etiology / Q000401:mortality; D002779:Cholestasis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D020878:Device Removal; D004322:Drainage / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D005548:Foreign-Body Migration / Q000209:etiology; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012008:Recurrence; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents; D062606:Tertiary Care Centers; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D008670:Metals
keywords: Benign biliary stricture; Chronic pancreatitis; ERCP; Fully covered self-expandable metal stents; SEMS