Gastric Outlet Obstruction Due to MalignancyPhase 4NCT02156505
Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction
A Phase 4 study testing placement of double bare stent and DoubleBare stent in people with Gastric Outlet Obstruction Due to Malignancy, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Outlet Obstruction Due to Malignancy
- What is being tested?
- placement of double bare stent and DoubleBare stent
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Jul 2015
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Malignant gastric outlet obstruction
- Symptoms compatible with gastric outlet obstruction
- An inoperable condition because of extent of disease or patient's conditions
Who cannot join
- History of enteral stent placement, undergone gastric surgery.
- Additional small bowel stenosis distal to gastric outlet obstruction.
- Refuse to be enrolled to study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Chan G Kim, M.D., +82-31-920-1620, glse@chol.com
Chan G Kim, M.D.
About this study
Official title: Phase IV Study of Double Bare Self-expandable Metallic Stent for Malignant Gastric Outlet Obstruction
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.
- Being tested
- placement of double bare stent, DoubleBare stent
- Keywords
- stent, gastric outlet obstruction, restenosis
- 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.
placement of double bare stentProcedure or surgery
DoubleBare stentDevice
| Study group | Role | What they receive |
|---|---|---|
| DoubleBare stent | Experimental | Placement of double bare stent Receives: Procedure: placement of double bare stent; Device: DoubleBare stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patency rate at 8 weeks after placement.
Measured: 8 weeks
Secondary outcomes (3)
Technical and clinical success rates
Measured: up to 8 weeks
re-stenosis rate
Measured: 8 weeks
migration rate
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Outlet Obstruction Due to MalignancyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Stent research group, Korean Society of Gastrointestinal Endoscopy, Korea
- Responsible party
- Principal investigator, Chan Gyoo Kim, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156505
- Sponsor's protocol ID
- NCCCTSMD12009
- Status last verified
- Jun 2014
- First submitted
- 2 Jun 2014
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Double Bare Self-expandable Metallic Stent for Malignant Gastric Outlet Obstruction
- ClinicalTrials.gov ID
- NCT02156505
- Acronym / sponsor ID
- NCCCTSMD12009
- Keywords
- stent, gastric outlet obstruction, restenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Stent research group, Korean Society of Gastrointestinal Endoscopy, Korea
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 5 Jun 2014 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DoubleBare stent | Experimental | Procedure: placement of double bare stent, Device: DoubleBare stentPlacement of double bare stent |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Malignant gastric outlet obstruction
- Symptoms compatible with gastric outlet obstruction
- An inoperable condition because of extent of disease or patient's conditions
Key exclusion criteria (3 listed)
- History of enteral stent placement, undergone gastric surgery.
- Additional small bowel stenosis distal to gastric outlet obstruction.
- Refuse to be enrolled to study.
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 |
|---|---|---|
| placement of double bare stent | Procedure or surgery | DoubleBare stent |
| DoubleBare stent | Device | DoubleBare stent |
Primary outcome
The patency rate at 8 weeks after placement.
Time frame: 8 weeks
3 secondary outcomes
Technical and clinical success rates
Time frame: up to 8 weeks
re-stenosis rate
Time frame: 8 weeks
migration rate
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
Related trials for Gastric Outlet Obstruction Due to Malignancy
Enrolling by invitationObservational study
Outcome of Patients With Malignant Gastric Outlet Obstruction Undergoing Endoscopic Ultrasound-guided Gastroenterostomy or Enteral Metal Stenting
Gastric Outlet Obstruction Due to Malignancy, EUS Guided Enteroenteric Anastomosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing placement of double bare stent and DoubleBare stent in people with Gastric Outlet Obstruction Due to Malignancy, run by National Cancer Center, Korea 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 3 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: status not confirmed, as of the sponsor's last update on 5 Jun 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chan G Kim, M.D. (+82-31-920-1620, glse@chol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patency rate at 8 weeks after placement. (time frame: 8 weeks). 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 5 Jun 2014.