Gastric Outlet Obstructions Tailored Covered Stents for GOO

Not Applicable

Completed

Conditions: Gastric Outlet Obstruction

Interventions: Device: Tailored stents MTN-WE-20/100-A
Device: Standard stents MTN-CG-s-20/100

Registration Number: NCT02299258

Lead Sponsor: The First People's Hospital of Yuhang District

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 63

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tailored stents MTN-WE-20/100-A	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.
Standard stents MTN-CG-s-20/100	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

Primary Outcome Measures

Name	Time	Method
Efficiency of Stents	up to 5 years	number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study

Secondary Outcome Measures