Gastric Outlet ObstructionNCT01839292
ComVi and D-type Stent in Malignant GOO
A study testing uncovered D-type stent insertion and double-layered ComVi stent insertion in people with Gastric Outlet Obstruction, run by Ajou University School of Medicine at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Outlet Obstruction
- What is being tested?
- uncovered D-type stent insertion and double-layered ComVi stent insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults 18 years of age or older
- obstructive symptoms due to unresectable malignant GOO
- a Karnofsky performance score of more than 30 (13)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Gastric Outlet Obstruction
- Being tested
- uncovered D-type stent insertion, double-layered ComVi stent insertion
- Keywords
- gastric outlet obstruction, palliative treatment, stent
- Medical subject headings
- Gastric Outlet Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uncovered D-type stent insertionDevice
double-layered ComVi stent insertionDevice
| Study group | Role | What they receive |
|---|---|---|
| uncovered D-type stent | Active comparator | uncovered D-type stent, which effectively reduces stent migration, especially in malignant colorectal obstruction Receives: Device: uncovered D-type stent insertion |
| double-layered ComVi stent | Active comparator | 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 Receives: Device: double-layered ComVi stent insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
the stent patency time from stent insertion to restenosis due to stent malfunction or death
Measured: Up to 1 years
Secondary outcomes (1)
stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate
Measured: up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startApr 2010
- Primary completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Outlet ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Center, Korea, Kyungpook National University Hospital, Hallym University, The Catholic University of Korea, Seoul National University, DongGuk University
- Responsible party
- Principal investigator, Sun Gyo Lim, Ajou University School of Medicine
- Investigators
- Jin Hong Kim, M.D., Ph.D., Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839292
- Sponsor's protocol ID
- AJIRB-DEV-DE4-10-009
- Status last verified
- Apr 2013
- First submitted
- 18 Apr 2013
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01839292
- Acronym / sponsor ID
- AJIRB-DEV-DE4-10-009
- Conditions
- Gastric Outlet Obstruction
- Keywords
- gastric outlet obstruction, palliative treatment, stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Center, Korea, Kyungpook National University Hospital, Hallym University, The Catholic University of Korea, Seoul National University, DongGuk University
- Study start
- Apr 2010
- Primary completion
- Aug 2012 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| uncovered D-type stent | Active comparator | Device: uncovered D-type stent insertionuncovered D-type stent, which effectively reduces stent migration, especially in malignant colorectal obstruction |
| double-layered ComVi stent | Active comparator | Device: double-layered ComVi stent insertiondouble-layered ComVi stent, which is a modified covered stent with an additional outer bare wire mesh to overcome both tumor ingrowth and stent migration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults 18 years of age or older
- obstructive symptoms due to unresectable malignant GOO
- a Karnofsky performance score of more than 30 (13)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uncovered D-type stent insertion | Device | uncovered D-type stent |
| double-layered ComVi stent insertion | Device | double-layered ComVi stent |
Primary outcome
the stent patency time from stent insertion to restenosis due to stent malfunction or death
Time frame: Up to 1 years
1 secondary outcome
stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate
Time frame: up to 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Hong Kim, M.D., Ph.D. principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uncovered D-type stent insertion and double-layered ComVi stent insertion in people with Gastric Outlet Obstruction, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the stent patency time from stent insertion to restenosis due to stent malfunction or death (time frame: Up to 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2013.