ComVi and D-type Stent in Malignant GOO

A Newly Designed Conformable Uncovered Versus Covered Self-expandable Metallic Stent for Palliation of Malignant Gastric Outlet Obstruction: a Prospective, Randomized Multicenter Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01839292

Enrollment

Registered

2013-04-24

Start date

2010-04-30

Completion date

Unknown

Last updated

2013-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Outlet Obstruction

Keywords

gastric outlet obstruction, palliative treatment, stent

Brief summary

Covered self-expandable metallic stents (SEMS) have been used to prevent tumor ingrowth, a common complication of uncovered SEMSs. However, they have revealed a high incidence of stent migration in patients with unresectable malignant gastric outlet obstruction (GOO). A conformable covered SEMS was introduced to overcome both stent migration and tumor ingrowth. The aims of this study were to evaluate the clinical outcomes of newly designed conformable covered and uncovered SEMS for palliation of malignant GOO.

Interventions

DEVICEuncovered D-type stent insertion

DEVICEdouble-layered ComVi stent insertion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* adults 18 years of age or older * obstructive symptoms due to unresectable malignant GOO * a Karnofsky performance score of more than 30 (13)

Exclusion criteria

* history of a previous SEMS insertion * the presence of obstruction in the gastrointestinal tract excluding the gastric outlet * severe comorbidities precluding the endoscopic procedure, such as cardiopulmonary disease, sepsis, and bleeding disorders * a life expectancy of less than 1 month after SEMS insertion * history of gastric surgery

Design outcomes

Primary

Measure	Time frame
the stent patency time from stent insertion to restenosis due to stent malfunction or death	Up to 1 years

Secondary

Measure	Time frame
stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate	up to 1 years

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026