Gastric Outlet Obstructions Tailored Covered Stents for GOO

NCT ID: NCT02299258

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-03-31

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.

Conditions

Gastric Outlet Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Tailored stents MTN-WE-20/100-A

Intervention Type: DEVICE

cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.

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

Group Type: EXPERIMENTAL

Standard stents MTN-CG-s-20/100

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Tailored stents MTN-WE-20/100-A

cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First People's Hospital of Yuhang District

OTHER

Sponsor Role: lead

Responsible Party

Ding Shi

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ding Shi

Role: STUDY_DIRECTOR

The First People's Hospital of Yuhang District

Locations

The First People's Hospital of Yuhang District

Hangzhou, , China

Countries

China

Other Identifiers

2011ZHE008

Identifier Type: -

Identifier Source: org_study_id