PMID- 22482918
OWN - NLM
STAT- MEDLINE
DCOM- 20121217
LR  - 20220408
IS  - 1097-6779 (Electronic)
IS  - 0016-5107 (Linking)
VI  - 76
IP  - 1
DP  - 2012 Jul
TI  - 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.
PG  - 84-92
LID - 10.1016/j.gie.2012.02.039 [doi]
AB  - 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.
CI  - Copyright (c) 2012 American Society for Gastrointestinal Endoscopy. Published by 
      Mosby, Inc. All rights reserved.
FAU - Isayama, Hiroyuki
AU  - Isayama H
AD  - Department of Gastroenterology, Graduate School of Medicine, The University of 
      Tokyo, Tokyo, Japan.
FAU - Mukai, Tsuyoshi
AU  - Mukai T
FAU - Itoi, Takao
AU  - Itoi T
FAU - Maetani, Iruru
AU  - Maetani I
FAU - Nakai, Yousuke
AU  - Nakai Y
FAU - Kawakami, Hiroshi
AU  - Kawakami H
FAU - Yasuda, Ichiro
AU  - Yasuda I
FAU - Maguchi, Hiroyuki
AU  - Maguchi H
FAU - Ryozawa, Shomei
AU  - Ryozawa S
FAU - Hanada, Keiji
AU  - Hanada K
FAU - Hasebe, Osamu
AU  - Hasebe O
FAU - Ito, Kei
AU  - Ito K
FAU - Kawamoto, Hirofumi
AU  - Kawamoto H
FAU - Mochizuki, Hitoshi
AU  - Mochizuki H
FAU - Igarashi, Yoshinori
AU  - Igarashi Y
FAU - Irisawa, Atsushi
AU  - Irisawa A
FAU - Sasaki, Tamito
AU  - Sasaki T
FAU - Togawa, Osamu
AU  - Togawa O
FAU - Hara, Taro
AU  - Hara T
FAU - Kamada, Hideki
AU  - Kamada H
FAU - Toda, Nobuo
AU  - Toda N
FAU - Kogure, Hirofumi
AU  - Kogure H
LA  - eng
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20120405
PL  - United States
TA  - Gastrointest Endosc
JT  - Gastrointestinal endoscopy
JID - 0010505
RN  - 0 (Alloys)
RN  - 0 (Silicones)
RN  - 12597-68-1 (Stainless Steel)
RN  - 2EWL73IJ7F (nitinol)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - *Alloys
MH  - Bile Duct Neoplasms/complications/pathology
MH  - Cholestasis/etiology/*therapy
MH  - Device Removal
MH  - Female
MH  - Gallbladder Neoplasms/complications/pathology
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Pancreatic Neoplasms/complications/pathology
MH  - Proportional Hazards Models
MH  - Prosthesis Design
MH  - *Prosthesis Failure
MH  - Recurrence
MH  - Silicones
MH  - *Stainless Steel
MH  - *Stents/adverse effects
MH  - Time Factors
EDAT- 2012/04/10 06:00
MHDA- 2012/12/18 06:00
CRDT- 2012/04/10 06:00
PHST- 2011/08/15 00:00 [received]
PHST- 2012/02/20 00:00 [accepted]
PHST- 2012/04/10 06:00 [entrez]
PHST- 2012/04/10 06:00 [pubmed]
PHST- 2012/12/18 06:00 [medline]
AID - S0016-5107(12)00204-0 [pii]
AID - 10.1016/j.gie.2012.02.039 [doi]
PST - ppublish
SO  - Gastrointest Endosc. 2012 Jul;76(1):84-92. doi: 10.1016/j.gie.2012.02.039. Epub 
      2012 Apr 5.