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gastric outlet obstruction tailored versus standard stents for malignant gastric outlet obstruction treatments
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard stents MTN-CG-s-20/100 | Device | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficiency of Stents | number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | bleeding, abdominal pain | up to 5 years |
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Inclusion Criteria:
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
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ding Shi | The First People's Hospital of Yuhang District | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First People's Hospital of Yuhang District | Hangzhou | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tailored Stents MTN-WE-20/100-A | 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. Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs. |
| FG001 | Standard Stents MTN-CG-s-20/100 | 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 Standard stents MTN-CG-s-20/100: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tailored Stents MTN-WE-20/100-A | 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. Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficiency of Stents | number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study | Posted | Number | participants | up to 5 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tailored Stents MTN-WE-20/100-A | 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. Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | GOOSS | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Ding Shi | The First People's Hospital of Yuhang District | +8657189369162 | shidingyuhang@163.com |
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| ID | Term |
|---|---|
| D017219 | Gastric Outlet Obstruction |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Tailored stents MTN-WE-20/100-A | Device | cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs. |
|
| BG001 | Standard Stents MTN-CG-s-20/100 | 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 Standard stents MTN-CG-s-20/100: 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gastric outlet obstruction score | Gastric outlet obstruction score ranges from 2(best possible outcome) to 4(worst possible outcome) | Mean | Full Range | units on a scale |
|
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
Standard stents MTN-CG-s-20/100: 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
|
|
| Secondary | Adverse Events | bleeding, abdominal pain | Posted | Number | participants | up to 5 years |
|
|
|
| 25 |
| 32 |
| 0 |
| 32 |
| EG001 | Standard Stents MTN-CG-s-20/100 | 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 Standard stents MTN-CG-s-20/100: 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 | 4 | 31 | 0 | 31 |
| Abdominal pain | Gastrointestinal disorders | GOOSS | Systematic Assessment |
|
| Food impaction | Gastrointestinal disorders | GOOSS | Systematic Assessment |
|
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