ComVi and D-type Stent in Malignant GOO

Ajou University School of Medicine89 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Gastric Outlet Obstruction

Interventions

uncovered D-type stent insertionDEVICE

double-layered ComVi stent insertionDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ajou University Hospital

Suwon, South Korea

Outcomes

Primary Outcomes

the stent patency time from stent insertion to restenosis due to stent malfunction or death

Time frame: Up to 1 years

Secondary Outcomes

stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate

Time frame: up to 1 years

Data from ClinicalTrials.gov

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