Gastric Outlet Obstructions Tailored Covered Stents for GOO

The First People's Hospital of Yuhang District63 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gastric Outlet Obstruction

Interventions

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

The First People's Hospital of Yuhang District

Hangzhou, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

Adverse Events

bleeding, abdominal pain

Time frame: up to 5 years

Data from ClinicalTrials.gov

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