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OpenTrials
Completed

NCT Number: NCT02299258

Gastric Outlet Obstructions Tailored Covered Stents for GOO

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

Completed

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First People's Hospital of Yuhang District

Hangzhou, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard stents MTN-CG-s-20/100

Device

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

Tailored stents MTN-WE-20/100-A

Device

cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.

Primary outcomes

  1. Efficiency of Stents

    Time frame: up to 5 years

    number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study

Secondary outcomes

  1. Adverse Events

    Time frame: up to 5 years

    bleeding, abdominal pain

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Yuhang District

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Nov 24, 2014
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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