Gastric Outlet ObstructionNCT02299258
Gastric Outlet Obstructions Tailored Covered Stents for GOO
A study testing Standard stents MTN-CG-s-20/100 and Tailored stents MTN-WE-20/100-A in people with Gastric Outlet Obstruction, run by The First People's Hospital of Yuhang District at 1 site in China.
Trial summary
gastric outlet obstruction tailored versus standard stents for malignant gastric outlet obstruction treatments Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Outlet Obstruction
- What is being tested?
- Standard stents MTN-CG-s-20/100 and Tailored stents MTN-WE-20/100-A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- May 2009to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- GOO defined by symptoms resulting in decreased oral intake (nausea, vomiting and inability to eat),the obstruction was caused by primary distal stomach cancer and the site of stenosis was between the gastric body and duodenum bulb
Who cannot join
- the presence of only mild symptoms in patients who could tolerate a liquid diet, clinical evidence of perforation or peritonitis, evidence of multiple small-bowel obstructions because of peritoneal seeding as well as diabetes or other diseases that affect gastric motility and use of promotility agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized Controlled Trial of Malignant Gastric Outlet Obstruction: Tailored Partially Covered Stents (Placed Fluoroscopically) Versus Standard Uncovered Stents (Placed Endoscopically)
gastric outlet obstruction tailored versus standard stents for malignant gastric outlet obstruction treatments
Read the detailed description
To determine the shape of the GOOs, stomach opacifications were performed using contrast media before stenting. In the GOO tailored group (33 cases), the distal stents were semi-spherical with a length of 20 mm and a diameter of 28 mm. The middle stent segments had diameters of 20 mm. The proximal ends of large cup-shaped stents had 53.3 ± 5.5 mm diameters and were 15 or 20 mm long, whereas the large funnel-shaped stents had 33.6 ± 3.6 mm diameters and were 25 or 30 mm long. The control group (32 cases) received standard uncovered stents (semi-spherical, with diameters of 28 mm and 20 mm long).Our hypothesis was that unresectable GOO tailored covered stents are superior to the standard uncovered ones in terms of stent re-obstruction and stent migration. In the current study the efficacy and safety of GOO tailored covered stents for the treatment of non-resectable GOOs caused by distal gastric cancer was compared with standard uncovered stents.
- Conditions
- Gastric Outlet Obstruction
- Being tested
- Standard stents MTN-CG-s-20/100, Tailored stents MTN-WE-20/100-A
- 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.
Standard stents MTN-CG-s-20/100Device
The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
Tailored stents MTN-WE-20/100-ADevice
cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.
| Study group | Role | What they receive |
|---|---|---|
| Tailored stents MTN-WE-20/100-A | Active comparator | The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane. Receives: Device: Tailored stents MTN-WE-20/100-A |
| Standard stents MTN-CG-s-20/100 | Experimental | Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm Receives: Device: Standard stents MTN-CG-s-20/100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of Stents
number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study
Measured: up to 5 years
Secondary outcomes (1)
Adverse Events
bleeding, abdominal pain
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startMay 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Yuhang District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Shi, The First People's Hospital of Yuhang District
- Investigators
- Ding Shi, Study director, The First People's Hospital of Yuhang District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299258
- Sponsor's protocol ID
- 2011ZHE008
- Status last verified
- Feb 2015
- First submitted
- 17 Nov 2014
- Last updated
- 12 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial of Malignant Gastric Outlet Obstruction: Tailored Partially Covered Stents (Placed Fluoroscopically) Versus Standard Uncovered Stents (Placed Endoscopically)
- ClinicalTrials.gov ID
- NCT02299258
- Acronym / sponsor ID
- 2011ZHE008
- Conditions
- Gastric Outlet Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- The First People's Hospital of Yuhang DistrictUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Posted 12 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
gastric outlet obstruction tailored versus standard stents for malignant gastric outlet obstruction treatments
Detailed description
To determine the shape of the GOOs, stomach opacifications were performed using contrast media before stenting. In the GOO tailored group (33 cases), the distal stents were semi-spherical with a length of 20 mm and a diameter of 28 mm. The middle stent segments had diameters of 20 mm. The proximal ends of large cup-shaped stents had 53.3 ± 5.5 mm diameters and were 15 or 20 mm long, whereas the large funnel-shaped stents had 33.6 ± 3.6 mm diameters and were 25 or 30 mm long. The control group (32 cases) received standard uncovered stents (semi-spherical, with diameters of 28 mm and 20 mm long).Our hypothesis was that unresectable GOO tailored covered stents are superior to the standard uncovered ones in terms of stent re-obstruction and stent migration. In the current study the efficacy and safety of GOO tailored covered stents for the treatment of non-resectable GOOs caused by distal gastric cancer was compared with standard uncovered stents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored stents MTN-WE-20/100-A | Active comparator | Device: Tailored stents MTN-WE-20/100-AThe distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane. |
| Standard stents MTN-CG-s-20/100 | Experimental | Device: Standard stents MTN-CG-s-20/100Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- GOO defined by symptoms resulting in decreased oral intake (nausea, vomiting and inability to eat),the obstruction was caused by primary distal stomach cancer and the site of stenosis was between the gastric body and duodenum bulb
Key exclusion criteria (1 listed)
- the presence of only mild symptoms in patients who could tolerate a liquid diet, clinical evidence of perforation or peritonitis, evidence of multiple small-bowel obstructions because of peritoneal seeding as well as diabetes or other diseases that affect gastric motility and use of promotility agents.
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 |
|---|---|---|
| Standard stents MTN-CG-s-20/100The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm | Device | Standard stents MTN-CG-s-20/100 |
| Tailored stents MTN-WE-20/100-Acup-shaped or funnel-shaped, according to the shapes of the proximal GOOs. | Device | Tailored stents MTN-WE-20/100-A |
Primary outcome
Efficiency of Stents
Time frame: up to 5 years
number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study
1 secondary outcome
Adverse Events
Time frame: up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.
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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.
Ding Shi study director
The First People's Hospital of Yuhang District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard stents MTN-CG-s-20/100 and Tailored stents MTN-WE-20/100-A in people with Gastric Outlet Obstruction, run by The First People's Hospital of Yuhang District at 1 site in China.
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 1 inclusion and 1 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 12 Feb 2015. 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 China. 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?
Yes. Results are posted in the registry (first posted 12 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficiency of Stents (time frame: up to 5 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 12 Feb 2015; AzTrials last refreshed its copy on 6 Nov 2026.