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