title: A Double-Layered Covered Biliary Metal Stent for the Management of Unresectable Malignant Biliary Obstruction: A Multicenter Feasibility Study.
abstract: OBJECTIVE
  The covered self-expandable metal stent (CMS) was developed to prevent tumor ingrowth-induced stent occlusion during the treatment of malignant biliary obstruction. However, complications such as cholecystitis, pancreatitis, and stent migration can occur after the endoscopic insertion of CMSs. The aim of the present study was to assess the efficacy and safety of a double-layered CMS (DCMS) for the management of malignant bile duct obstruction.
  
  
  METHODS
  DCMSs were endoscopically introduced into 59 patients with unresectable malignant extrahepatic biliary obstruction at four tertiary referral centers, and the patient medical records were retrospectively reviewed.
  
  
  RESULTS
  Both the technical and functional success rates were 100%. Procedure-related complications including pancreatitis, cholangitis, stent migration, and liver abscess occurred in five patients (8.5%). The median follow-up period was 265 days (range, 31 to 752 days). Cumulative stent patency rates were 68.2% and 40.8% at 6 and 12 months, respectively. At the final follow-up, the rate of stent occlusion was 33.9% (20/59), and the median stent patency period was 276 days (range, 2 to 706 days).
  
  
  CONCLUSIONS
  The clinical outcomes of DCMSs were comparable to the outcomes previously reported for CMSs with respect to stent patency period and complication rates.
authors.affiliation: Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea.
authors.forename: Jin-Seok
authors.initials: JS
authors.lastname: Park
authors.affiliation: Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea.|The National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (NCEED), Incheon, Korea.
authors.forename: Seok
authors.initials: S
authors.lastname: Jeong
authors.affiliation: Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea.|The National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (NCEED), Incheon, Korea.|Utah-Inha DDS & Advanced Therapeutics Research Center, Incheon, Korea.
authors.forename: Don Haeng
authors.initials: DH
authors.lastname: Lee
authors.affiliation: Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University School of Medicine, Bucheon, Korea.
authors.forename: Jong Ho
authors.initials: JH
authors.lastname: Moon
authors.affiliation: Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Kyu Taek
authors.initials: KT
authors.lastname: Lee
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.
authors.forename: Seok Ho
authors.initials: SH
authors.lastname: Dong
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001650:Bile Duct Neoplasms / Q000150:complications / Q000601:surgery; D001662:Biliary Tract Surgical Procedures / Q000295:instrumentation* / Q000379:methods; D002761:Cholangitis / Q000453:epidemiology / Q000209:etiology; D002779:Cholestasis / Q000209:etiology / Q000601:surgery*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005548:Foreign-Body Migration / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D010195:Pancreatitis / Q000453:epidemiology / Q000209:etiology; D011183:Postoperative Complications / Q000453:epidemiology* / Q000209:etiology; D012189:Retrospective Studies; D015607:Stents / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D008670:Metals
keywords: Adverse effects; Common bile duct neoplasms; Extrahepatic cholestasis; Feasibility studies; Stents