ComVi and D-type Stent in Malignant GOO

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastric Outlet Obstruction

Intervention / Treatment
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* Device: uncovered D-type stent insertion
* Device: double-layered ComVi stent insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: uncovered D-type stent<br>uncovered D-type stent, which effectively reduces stent migration, especially in malignant colorectal obstruction | Device: uncovered D-type stent insertion<br> <br> |
| Active Comparator: double-layered ComVi stent<br>double-layered ComVi stent, which is a modified covered stent with an additional outer bare wire mesh to overcome both tumor ingrowth and stent migration | Device: double-layered ComVi stent insertion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the stent patency time from stent insertion to restenosis due to stent malfunction or death |  | Up to 1 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric outlet obstruction, palliative treatment, stent