ComVi and D-type Stent in Malignant GOO

Ajou University School of Medicine

Status: Completed

Conditions: Gastric Outlet Obstruction

Treatments: Device: uncovered D-type stent insertion; Device: double-layered ComVi stent insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT01839292

AJIRB-DEV-DE4-10-009

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

uncovered D-type stent

Active Comparator group

Description:

uncovered D-type stent, which effectively reduces stent migration, especially in malignant colorectal obstruction

Treatment:

Device: uncovered D-type stent insertion

double-layered ComVi stent

Active Comparator group

Description:

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

Treatment:

Device: double-layered ComVi stent insertion