title: Fully-covered, self-expandable metal stents (CSEMS) in malignant distal biliary strictures: mid-term evaluation.
abstract: OBJECTIVE
  Limited data exist regarding fully-covered, self-expandable metal stents (CSEMS) with anchoring fins for the management of malignant distal biliary strictures. The aim of this study is to evaluate their safety and patency.
  
  
  METHODS
  Over a period of 2 years, 70 patients (45 males, 66 ± 13 years) underwent endoscopic retrograde cholangiopancreatography (ERCP) with placement of a 10-mm (67 patients) or 8-mm diameter (3 patients) CSEMS for the palliation of distal malignant biliary obstruction (pancreatic [53] or other [17]). Data were collected prospectively for survival and stent patency; complications were evaluated retrospectively.
  
  
  RESULTS
  After CSEMS placement, 17 patients proceeded to surgery, and 53 patients were deemed unresectable. Mean survival for non-surgical candidates was 180 days (range: 15-1091), and 170 days (range: 9-589) for patients who underwent surgical management. CSEMS were left in place and remained patent for a mean of 163 days (range: 15-1091) in non-surgical candidates, and a mean of 55 days (range: 5-126) in surgical candidates. Complications during placement included wire perforations (4) and proximal deployment requiring repositioning (4), one of which was complicated by a bile leak. Post-procedure complications were observed in 24 cases (34%) and included post-ERCP pancreatitis (8, with 2 of them severe), post-procedure pain (5, with 3 requiring admission), cholecystitis (3), stent occlusion (3), cholangitis (2), proximal migration (1), post-sphincterotomy bleeding (1), and sepsis leading to death (1).
  
  
  CONCLUSIONS
  CSEMS appear to provide acceptable short-term patency rates; however, their limited long-term patency and high complication rate might limit their widespread use. Further long-term prospective data are required to confirm this observation.
authors.affiliation: Digestive Health Center of Excellence, University of Virginia, Charlottesville, Virginia, USA.
authors.forename: Mihir
authors.initials: M
authors.lastname: Bakhru
authors.forename: Henry C
authors.initials: HC
authors.lastname: Ho
authors.forename: Vishal
authors.initials: V
authors.lastname: Gohil
authors.forename: Andrew Y
authors.initials: AY
authors.lastname: Wang
authors.forename: Kristi
authors.initials: K
authors.lastname: Ellen
authors.forename: Bryan G
authors.initials: BG
authors.lastname: Sauer
authors.forename: Vanessa M
authors.initials: VM
authors.lastname: Shami
authors.forename: Michel
authors.initials: M
authors.lastname: Kahaleh
mesh_terms: D000368:Aged; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002779:Cholestasis / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D004067:Digestive System Neoplasms / Q000150:complications* / Q000401:mortality / Q000628:therapy; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D010166:Palliative Care; D011474:Prosthesis Design; D012189:Retrospective Studies; D015607:Stents; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D014768:Virginia
chemical_list: D008670:Metals