NCT02299258

Gastric Outlet Obstructions Tailored Covered Stents for GOO

A Multicenter Randomized Controlled Trial of Malignant Gastric Outlet Obstruction: Tailored Partially Covered Stents (Placed Fluoroscopically) Versus Standard Uncovered Stents (Placed Endoscopically)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: The First People's Hospital of Yuhang District · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

gastric outlet obstruction tailored versus standard stents for malignant gastric outlet obstruction treatments

Detailed description

To determine the shape of the GOOs, stomach opacifications were performed using contrast media before stenting. In the GOO tailored group (33 cases), the distal stents were semi-spherical with a length of 20 mm and a diameter of 28 mm. The middle stent segments had diameters of 20 mm. The proximal ends of large cup-shaped stents had 53.3 ± 5.5 mm diameters and were 15 or 20 mm long, whereas the large funnel-shaped stents had 33.6 ± 3.6 mm diameters and were 25 or 30 mm long. The control group (32 cases) received standard uncovered stents (semi-spherical, with diameters of 28 mm and 20 mm long).Our hypothesis was that unresectable GOO tailored covered stents are superior to the standard uncovered ones in terms of stent re-obstruction and stent migration. In the current study the efficacy and safety of GOO tailored covered stents for the treatment of non-resectable GOOs caused by distal gastric cancer was compared with standard uncovered stents.

Conditions

• Gastric Outlet Obstruction

Interventions

Type	Name	Description
DEVICE	Standard stents MTN-CG-s-20/100	The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
DEVICE	Tailored stents MTN-WE-20/100-A	cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.

Timeline

• Start date: 2009-05-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2014-11-24
• Last updated: 2015-02-12
• Results posted: 2015-02-12

Locations

1 site across 1 country: China