Management of malignant gastric outlet obstruction with a modified triple-layer covered metal stent

Gastrointest Endosc. 2012 Apr;75(4):757-63. doi: 10.1016/j.gie.2011.11.035. Epub 2012 Jan 28.


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.

Design: Multicenter, prospective cohort study.

Setting: Three tertiary referral centers.

Patients: 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.

Interventions: Endoscopic placement of the modified covered, triple-layer metal stent.

Main outcome measurements: 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.

Limitations: 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. (

Clinical trial registration number: UMIN000004566.).

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Alloys
  • Bile Duct Neoplasms / complications*
  • Carcinoma / complications*
  • Cholangiocarcinoma / complications
  • Female
  • Gastric Outlet Obstruction / etiology*
  • Gastric Outlet Obstruction / therapy*
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Pancreatic Neoplasms / complications*
  • Prosthesis Failure
  • Stents* / adverse effects
  • Stomach Neoplasms / complications*


  • Alloys
  • nitinol