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Gastric Outlet Obstructions Tailored Covered Stents for GOO

Primary Purpose

Gastric Outlet Obstruction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Standard stents MTN-CG-s-20/100
Tailored stents MTN-WE-20/100-A
Sponsored by
The First People's Hospital of Yuhang District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Outlet Obstruction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First People's Hospital of Yuhang District

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tailored stents MTN-WE-20/100-A

Standard stents MTN-CG-s-20/100

Arm Description

The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.

Standard uncovered stents were used in the control group. 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse Events
bleeding, abdominal pain

Full Information

First Posted
November 17, 2014
Last Updated
February 10, 2015
Sponsor
The First People's Hospital of Yuhang District
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1. Study Identification

Unique Protocol Identification Number
NCT02299258
Brief Title
Gastric Outlet Obstructions Tailored Covered Stents for GOO
Official Title
A Multicenter Randomized Controlled Trial of Malignant Gastric Outlet Obstruction: Tailored Partially Covered Stents (Placed Fluoroscopically) Versus Standard Uncovered Stents (Placed Endoscopically)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First People's Hospital of Yuhang District

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Outlet Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tailored stents MTN-WE-20/100-A
Arm Type
Active Comparator
Arm Description
The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.
Arm Title
Standard stents MTN-CG-s-20/100
Arm Type
Experimental
Arm Description
Standard uncovered stents were used in the control group. 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
Intervention Type
Device
Intervention Name(s)
Standard stents MTN-CG-s-20/100
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Tailored stents MTN-WE-20/100-A
Intervention Description
cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.
Primary Outcome Measure Information:
Title
Efficiency of Stents
Description
number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
Adverse Events
Description
bleeding, abdominal pain
Time Frame
up to 5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ding Shi
Organizational Affiliation
The First People's Hospital of Yuhang District
Official's Role
Study Director
Facility Information:
Facility Name
The First People's Hospital of Yuhang District
City
Hangzhou
Country
China

12. IPD Sharing Statement

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Gastric Outlet Obstructions Tailored Covered Stents for GOO

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