Gastric Outlet Obstruction
Conditions
Brief summary
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.
Interventions
DEVICEStandard 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
DEVICETailored stents MTN-WE-20/100-A
cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.
Sponsors
The First People's Hospital of Yuhang District
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency of Stents | up to 5 years | number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | up to 5 years | bleeding, abdominal pain |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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 | 31 |
| Total | 63 |
Baseline characteristics
| Characteristic | Tailored Stents MTN-WE-20/100-A | Standard Stents MTN-CG-s-20/100 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 32 Participants | 31 Participants | 63 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 76.4 years STANDARD_DEVIATION 7.7 | 75.8 years STANDARD_DEVIATION 7.6 | 76.1 years STANDARD_DEVIATION 7.7 |
| Gastric outlet obstruction score | 3.2 units on a scale | 3.1 units on a scale | 3.2 units on a scale |
| Region of Enrollment China | 32 participants | 31 participants | 63 participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 29 Participants |
| Sex: Female, Male Male | 18 Participants | 16 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 31 |
| serious Total, serious adverse events | 25 / 32 | 4 / 31 |
Outcome results
Primary
Efficiency of Stents
number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study
Time frame: up to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Stents MTN-WE-20/100-A | Efficiency of Stents | 1 participants |
| Standard Stents MTN-CG-s-20/100 | Efficiency of Stents | 7 participants |
Secondary
Adverse Events
bleeding, abdominal pain
Time frame: up to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Stents MTN-WE-20/100-A | Adverse Events | 25 participants |
| Standard Stents MTN-CG-s-20/100 | Adverse Events | 4 participants |