Document Detail

Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal malignant biliary obstruction: the WATCH study.
MedLine Citation:
PMID:  22482918     Owner:  NLM     Status:  Publisher    
BACKGROUND: Covered self-expandable metal stents (CSEMSs) were developed to prevent tumor ingrowth, but stent migration is one of the problems with CSEMSs. OBJECTIVE: To evaluate a new, commercially available CSEMS with flared ends and low axial force compared with a commercially available CSEMS without the anti-migration system and high axial force. DESIGN: Multicenter, prospective study with a historical cohort. SETTING: Twenty Japanese referral centers. PATIENTS: This study involved patients with unresectable distal malignant biliary obstruction. INTERVENTION: Placement of a new, commercially available, partially covered SEMS. MAIN OUTCOME MEASUREMENTS: Recurrent biliary obstruction rate, time to recurrent biliary obstruction, stent-related complications, survival. RESULTS: Between April 2009 and March 2010, 141 patients underwent partially covered nitinol stent placement, and between May 2001 and January 2007, 138 patients underwent placement of partially covered stainless stents as a historical control. The silicone cover of the partially covered nitinol stents prevented tumor ingrowth. There were no significant differences in survival (229 vs 219 days; P = .250) or the rate of recurrent biliary obstruction (33% vs 38%; P = .385) between partially covered nitinol stents and partially covered stainless stents. Stent migration was less frequent (8% vs 17%; P = .019), and time to recurrent biliary obstruction was significantly longer (373 vs 285 days; P = .007) with partially covered nitinol stents. Stent removal was successful in 26 of 27 patients (96%). LIMITATIONS: Nonrandomized, controlled trial. CONCLUSION: Partially covered nitinol stents with an anti-migration system and less axial force demonstrated longer time to recurrent biliary obstruction with no tumor ingrowth and less stent migration. (Clinical trial registration number: UMIN000002293.).
Hiroyuki Isayama; Tsuyoshi Mukai; Takao Itoi; Iruru Maetani; Yousuke Nakai; Hiroshi Kawakami; Ichiro Yasuda; Hiroyuki Maguchi; Shomei Ryozawa; Keiji Hanada; Osamu Hasebe; Kei Ito; Hirofumi Kawamoto; Hitoshi Mochizuki; Yoshinori Igarashi; Atsushi Irisawa; Tamito Sasaki; Osamu Togawa; Taro Hara; Hideki Kamada; Nobuo Toda; Hirofumi Kogure
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-4-4
Journal Detail:
Title:  Gastrointestinal endoscopy     Volume:  -     ISSN:  1097-6779     ISO Abbreviation:  -     Publication Date:  2012 Apr 
Date Detail:
Created Date:  2012-4-9     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0010505     Medline TA:  Gastrointest Endosc     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.
Department of Gastroenterology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
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