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ComVi and D-type Stent in Malignant GOO

A

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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