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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


N/A
18 Years
N/A
Not Enrolling
Both
Gastric Outlet Obstruction

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

Up to 1 years

Safety Issue:

No

Principal Investigator

Jin Hong Kim, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ajou University School of Medicine

Authority:

Korea: Institutional Review Board

Study ID:

AJIRB-DEV-DE4-10-009

NCT ID:

NCT01839292

Start Date:

April 2010

Completion Date:

Related Keywords:

  • Gastric Outlet Obstruction
  • gastric outlet obstruction
  • palliative treatment
  • stent
  • Gastric Outlet Obstruction
  • Pyloric Stenosis

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