Gastric Outlet Obstructions Tailored Covered Stents for GOO

Not Applicable

Completed

• Conditions: Gastric Outlet Obstruction

• Registration Number: NCT02299258
• Lead Sponsor: The First People's Hospital of Yuhang District

Brief 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.

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-20
• Results First Submitted: 2014-11-22
• Study First Posted: 2014-11-24
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-10
• Last Update Submitted: 2015-02-10
• Results First Posted: 2015-02-12
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

GOO defined by symptoms resulting in decreased oral intake (nausea, vomiting and inability to eat),the obstruction was caused by primary distal stomach cancer and the site of stenosis was between the gastric body and duodenum bulb

Exclusion Criteria

the presence of only mild symptoms in patients who could tolerate a liquid diet, clinical evidence of perforation or peritonitis, evidence of multiple small-bowel obstructions because of peritoneal seeding as well as diabetes or other diseases that affect gastric motility and use of promotility agents.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficiency of Stents	up to 5 years	number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study

Secondary Outcome Measures

Name	Time	Method
Adverse Events	up to 5 years	bleeding, abdominal pain

Trial Locations

Locations (1)

The First People's Hospital of Yuhang District; 🇨🇳 Hangzhou, China