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Clinical Trials/NCT01839292
NCT01839292
Completed
Not Applicable

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

Ajou University School of Medicine1 site in 1 country89 target enrollmentApril 2010
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ConditionsGastric Outlet Obstruction

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Outlet Obstruction
Sponsor
Ajou University School of Medicine
Enrollment
89
Locations
1
Primary Endpoint
the stent patency time from stent insertion to restenosis due to stent malfunction or death
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
August 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ajou University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Sun Gyo Lim

Assistant professor

Ajou University School of Medicine

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Up to 1 years

Secondary Outcomes

  • stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate(up to 1 years)

Study Sites (1)

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