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The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents (SEMS)

Primary Purpose

Malignant Gastric Outlet Obstruction

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Winged stent (partially covered)
Winged stent (uncovered)
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Gastric Outlet Obstruction focused on measuring winged stents, Self-expandable Metal Stents(SEMS), partial covered, uncovered, endoscopic insertion

Eligibility Criteria

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

Inclusion Criteria:

  1. Gastric outlet obstruction symptom
  2. Diagnosis of gastric outlet obstruction by radiologist or endoscopist
  3. Gastric outlet obstruction by malignant disease
  4. Aged over 19
  5. Informed consent

Exclusion Criteria:

  1. Gastric outlet obstruction by benign disease or infectious disease
  2. Could not endoscopic intervention by poor general condition
  3. Refusal of patient

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

winged stent group

Arm Description

participants who are assigned to winged-stent group will be treated with deployment of a winged stent(partially covered or uncovered SEMS).

Outcomes

Primary Outcome Measures

Complication rate(stent migration and tumor ingrowth) of new designed winged stent
It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.

Secondary Outcome Measures

Evaluate the technical success rate of SEMS insertion
It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.
Evaluate the clinical success rate of SEMS insertion
It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.
Difference of insertion time between previous stent insertion and new designed stent

Full Information

First Posted
May 4, 2015
Last Updated
May 7, 2015
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02440724
Brief Title
The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents
Acronym
SEMS
Official Title
The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Gastric Outlet Obstruction
Keywords
winged stents, Self-expandable Metal Stents(SEMS), partial covered, uncovered, endoscopic insertion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
winged stent group
Arm Type
Experimental
Arm Description
participants who are assigned to winged-stent group will be treated with deployment of a winged stent(partially covered or uncovered SEMS).
Intervention Type
Device
Intervention Name(s)
Winged stent (partially covered)
Intervention Description
A winged stent is a newly designed self-expandable metal stents(SEMS). Partially covered, or uncovered winged stent will be placed via the endoscopic intervention for malignant gastric outlet obstruction.
Intervention Type
Device
Intervention Name(s)
Winged stent (uncovered)
Intervention Description
A winged stent is a newly designed self-expandable metal stents(SEMS). Partially covered, or uncovered winged stent will be placed via the endoscopic intervention for malignant gastric outlet obstruction.
Primary Outcome Measure Information:
Title
Complication rate(stent migration and tumor ingrowth) of new designed winged stent
Description
It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.
Time Frame
up to 16 weeks from stent insertion
Secondary Outcome Measure Information:
Title
Evaluate the technical success rate of SEMS insertion
Description
It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.
Time Frame
up to 16 weeks from stent insertion
Title
Evaluate the clinical success rate of SEMS insertion
Description
It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.
Time Frame
up to 16 weeks from stent insertion
Title
Difference of insertion time between previous stent insertion and new designed stent
Time Frame
1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gastric outlet obstruction symptom Diagnosis of gastric outlet obstruction by radiologist or endoscopist Gastric outlet obstruction by malignant disease Aged over 19 Informed consent Exclusion Criteria: Gastric outlet obstruction by benign disease or infectious disease Could not endoscopic intervention by poor general condition Refusal of patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
myungeun lee, BA
Phone
+82-2-3010-7190
Email
lme23@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Sojung Park, BA
Phone
+82-2-3010-7190
Email
sojung@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Yong Ahn, Professor
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
myungeun lee, BA
Phone
+82-2-3010-7190
Email
lme23@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Ji Yong Ahn, Professor

12. IPD Sharing Statement

Learn more about this trial

The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents

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