Clinical Trial: Gastric Outlet Obstructions Tailored Covered Stents for GOO
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter Randomized Controlled Trial of Malignant Gastric Outlet Obstruction: Tailored Partially Covered Stents (Placed Fluoroscopically) Versus Standard Uncovered St
Brief Summary: gastric outlet obstruction tailored versus standard stents for malignant gastric outlet obstruction treatments
Detailed Summary: 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.
Sponsor: The First People's Hospital of Yuhang District
Current Primary Outcome: Efficiency of Stents [ Time Frame: up to 5 years ]
Original Primary Outcome: Efficiency of Stents [ Time Frame: up to 5 years ]
Current Secondary Outcome: Adverse Events [ Time Frame: up to 5 years ]
Original Secondary Outcome: Adverse Events [ Time Frame: up to 5 years ]
Information By: The First People's Hospital of Yuhang District
Dates:
Date Received: November 17, 2014
Date Started: May 2009
Date Completion:
Last Updated: February 10, 2015
Last Verified: February 2015
