Document Detail

A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction.
MedLine Citation:
PMID:  21034891     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The most common complication of uncovered biliary self-expandable metal stents (SEMSs) is tumor ingrowth. The addition of an impenetrable covering may prolong stent patency.
OBJECTIVE: To compare stent patency between uncovered and partially covered SEMSs in malignant biliary obstruction.
DESIGN: Multicenter randomized trial.
SETTING: Four teaching hospitals.
PATIENTS: Adults with inoperable distal malignant biliary obstruction.
INTERVENTIONS: Uncovered or partially covered SEMS insertion.
MAIN OUTCOME MEASURES: Time to recurrent biliary obstruction, patient survival, serious adverse events, and mechanism of recurrent biliary obstruction.
RESULTS: From October 2002 to May 2008, 129 patients were randomized. Recurrent biliary obstruction was observed in 11 of 61 uncovered SEMSs (18%) and 20 of 68 partially covered SEMSs (29%). The median times to recurrent biliary obstruction were 711 days and 357 days for the uncovered and partially covered SEMS groups, respectively (P = .530). Median patient survival was 239 days for the uncovered SEMS and 227 days for the partially covered SEMS groups (P = .997). Serious adverse events occurred in 27 (44%) and 42 (62%) patients in the uncovered and partially covered SEMS groups, respectively (P = .046). None of the uncovered and 8 (12%) of the partially covered SEMSs migrated (P = .0061).
LIMITATIONS: Intended sample size was not reached. Allocation to treatment groups was unequal.
CONCLUSIONS: There was no significant difference in time to recurrent biliary obstruction or patient survival between the partially covered and uncovered SEMS groups. Partially covered SEMSs were associated with more serious adverse events, particularly migration.
Jennifer J Telford; David L Carr-Locke; Todd H Baron; John M Poneros; Brenna C Bounds; Peter B Kelsey; Robert H Schapiro; Christopher S Huang; David R Lichtenstein; Brian C Jacobson; John R Saltzman; Christopher C Thompson; David G Forcione; Christopher J Gostout; William R Brugge
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Gastrointestinal endoscopy     Volume:  72     ISSN:  1097-6779     ISO Abbreviation:  Gastrointest. Endosc.     Publication Date:  2010 Nov 
Date Detail:
Created Date:  2010-11-01     Completed Date:  2011-04-19     Revised Date:  2011-07-20    
Medline Journal Info:
Nlm Unique ID:  0010505     Medline TA:  Gastrointest Endosc     Country:  United States    
Other Details:
Languages:  eng     Pagination:  907-14     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.
St. Paul's Hospital, Vancouver, British Columbia, Canada.
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MeSH Terms
Aged, 80 and over
Biliary Tract Neoplasms / complications,  pathology*,  therapy
Cholangiopancreatography, Endoscopic Retrograde*
Cholestasis / etiology,  pathology,  therapy*
Cohort Studies
Disease-Free Survival
Equipment Design
Middle Aged
Palliative Care*
Treatment Outcome
Reg. No./Substance:
Comment In:
Gastrointest Endosc. 2010 Nov;72(5):924-6   [PMID:  21034893 ]
Gastrointest Endosc. 2011 Jun;73(6):1329-30; author reply 1330-1   [PMID:  21628024 ]

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