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Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction

Primary Purpose

Gastric Outlet Obstruction Due to Malignancy

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
placement of double bare stent
DoubleBare stent
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Outlet Obstruction Due to Malignancy focused on measuring stent, gastric outlet obstruction, restenosis

Eligibility Criteria

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

Inclusion Criteria:

  • Malignant gastric outlet obstruction
  • Symptoms compatible with gastric outlet obstruction
  • An inoperable condition because of extent of disease or patient's conditions

Exclusion Criteria:

  • History of enteral stent placement, undergone gastric surgery.
  • Additional small bowel stenosis distal to gastric outlet obstruction.
  • Refuse to be enrolled to study.

Sites / Locations

  • National Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DoubleBare stent

Arm Description

Placement of double bare stent

Outcomes

Primary Outcome Measures

The patency rate at 8 weeks after placement.

Secondary Outcome Measures

Technical and clinical success rates
re-stenosis rate
migration rate

Full Information

First Posted
June 2, 2014
Last Updated
June 4, 2014
Sponsor
National Cancer Center, Korea
Collaborators
Stent research group, Korean Society of Gastrointestinal Endoscopy, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02156505
Brief Title
Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction
Official Title
Phase IV Study of Double Bare Self-expandable Metallic Stent for Malignant Gastric Outlet Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
Collaborators
Stent research group, Korean Society of Gastrointestinal Endoscopy, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Self-expandable metallic stents provide effective palliation of malignant gastric outlet obstruction. However, uncovered stent are often associated with re-stenosis caused by tumor in-growth through the stent mesh. The Self-expandable metallic stents which has the design of smaller wire mesh size (double bare stent) were developed and used in Korea. This new design was developed to minimize the re-stenosis of uncovered stent, but the outcome is unknown. The end point of this study is the 8-weeks patency rate after placement of double bare as well as technical and clinical success rates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Outlet Obstruction Due to Malignancy
Keywords
stent, gastric outlet obstruction, restenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DoubleBare stent
Arm Type
Experimental
Arm Description
Placement of double bare stent
Intervention Type
Procedure
Intervention Name(s)
placement of double bare stent
Intervention Type
Device
Intervention Name(s)
DoubleBare stent
Primary Outcome Measure Information:
Title
The patency rate at 8 weeks after placement.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Technical and clinical success rates
Time Frame
up to 8 weeks
Title
re-stenosis rate
Time Frame
8 weeks
Title
migration rate
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Malignant gastric outlet obstruction Symptoms compatible with gastric outlet obstruction An inoperable condition because of extent of disease or patient's conditions Exclusion Criteria: History of enteral stent placement, undergone gastric surgery. Additional small bowel stenosis distal to gastric outlet obstruction. Refuse to be enrolled to study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chan G Kim, M.D.
Phone
+82-31-920-1620
Email
glse@chol.com
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chan G Kim, M.D.
Phone
+82-31-920-1620
Email
glse@chol.com
First Name & Middle Initial & Last Name & Degree
Chan G Kim, M.D.

12. IPD Sharing Statement

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Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction

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