Gastric Outlet Obstructions Tailored Covered Stents for GOO

Gastric Outlet Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299258
• Other study ID #: 2011ZHE008
• Status: Completed
• Phase: N/A
• First received: November 17, 2014
• Last updated: February 10, 2015
• Start date: May 2009
• Est. completion date: March 2013

Study information

• Verified date: February 2015
• Source: The First People's Hospital of Yuhang District
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

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
• Tailored stents MTN-WE-20/100-A
cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.

Locations

Country	Name	City	State
China	The First People's Hospital of Yuhang District	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Yuhang District

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficiency of Stents	number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study	up to 5 years	Yes
Secondary	Adverse Events	bleeding, abdominal pain	up to 5 years	Yes