Back to resultsComVi and D-type Stent in Malignant GOO
Primary Purpose
Gastric Outlet Obstruction
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
uncovered D-type stent insertion
double-layered ComVi stent insertion
Sponsored by
About this trial
This is an interventional supportive care trial for Gastric Outlet Obstruction focused on measuring gastric outlet obstruction, palliative treatment, stent
Eligibility Criteria
Inclusion Criteria:
- adults 18 years of age or older
- obstructive symptoms due to unresectable malignant GOO
- a Karnofsky performance score of more than 30 (13)
Exclusion Criteria:
- history of a previous SEMS insertion
- the presence of obstruction in the gastrointestinal tract excluding the gastric outlet
- severe comorbidities precluding the endoscopic procedure, such as cardiopulmonary disease, sepsis, and bleeding disorders
- a life expectancy of less than 1 month after SEMS insertion
- history of gastric surgery
Sites / Locations
- Ajou University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
uncovered D-type stent
double-layered ComVi stent
Arm Description
uncovered D-type stent, which effectively reduces stent migration, especially in malignant colorectal obstruction
double-layered ComVi stent, which is a modified covered stent with an additional outer bare wire mesh to overcome both tumor ingrowth and stent migration
Outcomes
Primary Outcome Measures
the stent patency time from stent insertion to restenosis due to stent malfunction or death
Secondary Outcome Measures
stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate
Full Information
NCT ID
NCT01839292
First Posted
April 18, 2013
Last Updated
April 22, 2013
Sponsor
Ajou University School of Medicine
Collaborators
National Cancer Center, Korea, Kyungpook National University Hospital, Hallym University, The Catholic University of Korea, Seoul National University, DongGuk University
1. Study Identification
Unique Protocol Identification Number
NCT01839292
Brief Title
ComVi and D-type Stent in Malignant GOO
Official Title
A Newly Designed Conformable Uncovered Versus Covered Self-expandable Metallic Stent for Palliation of Malignant Gastric Outlet Obstruction: a Prospective, Randomized Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
Collaborators
National Cancer Center, Korea, Kyungpook National University Hospital, Hallym University, The Catholic University of Korea, Seoul National University, DongGuk University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Covered self-expandable metallic stents (SEMS) have been used to prevent tumor ingrowth, a common complication of uncovered SEMSs. However, they have revealed a high incidence of stent migration in patients with unresectable malignant gastric outlet obstruction (GOO). A conformable covered SEMS was introduced to overcome both stent migration and tumor ingrowth. The aims of this study were to evaluate the clinical outcomes of newly designed conformable covered and uncovered SEMS for palliation of malignant GOO.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Outlet Obstruction
Keywords
gastric outlet obstruction, palliative treatment, stent
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
uncovered D-type stent
Arm Type
Active Comparator
Arm Description
uncovered D-type stent, which effectively reduces stent migration, especially in malignant colorectal obstruction
Arm Title
double-layered ComVi stent
Arm Type
Active Comparator
Arm Description
double-layered ComVi stent, which is a modified covered stent with an additional outer bare wire mesh to overcome both tumor ingrowth and stent migration
Intervention Type
Device
Intervention Name(s)
uncovered D-type stent insertion
Intervention Type
Device
Intervention Name(s)
double-layered ComVi stent insertion
Primary Outcome Measure Information:
Title
the stent patency time from stent insertion to restenosis due to stent malfunction or death
Time Frame
Up to 1 years
Secondary Outcome Measure Information:
Title
stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate
Time Frame
up to 1 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults 18 years of age or older
obstructive symptoms due to unresectable malignant GOO
a Karnofsky performance score of more than 30 (13)
Exclusion Criteria:
history of a previous SEMS insertion
the presence of obstruction in the gastrointestinal tract excluding the gastric outlet
severe comorbidities precluding the endoscopic procedure, such as cardiopulmonary disease, sepsis, and bleeding disorders
a life expectancy of less than 1 month after SEMS insertion
history of gastric surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Hong Kim, M.D., Ph.D.
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
ComVi and D-type Stent in Malignant GOO
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