title: Management of malignant gastric outlet obstruction with a modified triple-layer covered metal stent.
abstract: BACKGROUND
  A high incidence of migration with covered metal stents has been reported in malignant gastric outlet obstruction (GOO). A newly modified, partially covered, triple-layer nitinol stent was developed that has a longer uncovered portion (5-15 mm) to prevent stent migration.
  
  
  OBJECTIVE
  To estimate the efficacy and safety of the modified covered, triple-layer metal stent.
  
  
  METHODS
  Multicenter, prospective cohort study.
  
  
  METHODS
  Three tertiary referral centers.
  
  
  METHODS
  Fifty consecutive patients (26 with pancreatic carcinoma, 14 with gastric carcinoma, 9 with cholangiocarcinoma, 1 with a metastatic node) who presented with symptomatic unresectable malignant GOO between April 2007 and March 2010.
  
  
  METHODS
  Endoscopic placement of the modified covered, triple-layer metal stent.
  
  
  METHODS
  The primary endpoint was to improve the GOO scoring system (GOOSS) score. Secondary endpoints were success rate, patency, and complications.
  
  
  RESULTS
  The median GOOSS score improved significantly (P < .0001) after stenting (from 0 to 3). The technical and clinical success rates were 100% and 90%, respectively. Stent occlusion by tumor overgrowth or ingrowth at the uncovered portion developed in 5 patients (10%). Asymptomatic stent migration occurred in 3 patients (6%) receiving chemotherapy at 95, 230, and 553 days after stent placement, but these patients tolerated solid food 68, 260, and 142 days after stent migration, respectively. Other complications occurred in 1 patient with insufficient expansion, cholangitis, and pancreatitis. No procedure-related deaths occurred.
  
  
  CONCLUSIONS
  A single-arm study in tertiary-care centers.
  
  
  CONCLUSIONS
  The modified covered, triple-layer metal stent was effective and safe for managing malignant GOO and can prevent tumor ingrowth and stent migration. (
  
  
  BACKGROUND
  UMIN000004566.).
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Isayama
authors.forename: Takashi
authors.initials: T
authors.lastname: Sasaki
authors.forename: Yousuke
authors.initials: Y
authors.lastname: Nakai
authors.forename: Osamu
authors.initials: O
authors.lastname: Togawa
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Kogure
authors.forename: Naoki
authors.initials: N
authors.lastname: Sasahira
authors.forename: Yoko
authors.initials: Y
authors.lastname: Yashima
authors.forename: Kazumichi
authors.initials: K
authors.lastname: Kawakubo
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Ito
authors.forename: Kenji
authors.initials: K
authors.lastname: Hirano
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tsujino
authors.forename: Nobuo
authors.initials: N
authors.lastname: Toda
authors.forename: Minoru
authors.initials: M
authors.lastname: Tada
authors.forename: Masao
authors.initials: M
authors.lastname: Omata
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Koike
mesh_terms: D000368:Aged; D000497:Alloys; D001650:Bile Duct Neoplasms / Q000150:complications*; D002277:Carcinoma / Q000150:complications*; D018281:Cholangiocarcinoma / Q000150:complications; D005260:Female; D017219:Gastric Outlet Obstruction / Q000209:etiology* / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000150:complications*; D011475:Prosthesis Failure; D015607:Stents / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000150:complications*
chemical_list: D000497:Alloys; C013616:nitinol