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Clinical Trials/NCT02440724
NCT02440724
Unknown
Not Applicable

The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents

Asan Medical Center1 site in 1 country33 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malignant Gastric Outlet Obstruction
Sponsor
Asan Medical Center
Enrollment
33
Locations
1
Primary Endpoint
Complication rate(stent migration and tumor ingrowth) of new designed winged stent
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ji Yong Ahn

Assistant Professor

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • Gastric outlet obstruction symptom
  • Diagnosis of gastric outlet obstruction by radiologist or endoscopist
  • Gastric outlet obstruction by malignant disease
  • Aged over 19
  • Informed consent

Exclusion Criteria

  • Gastric outlet obstruction by benign disease or infectious disease
  • Could not endoscopic intervention by poor general condition
  • Refusal of patient

Outcomes

Primary Outcomes

Complication rate(stent migration and tumor ingrowth) of new designed winged stent

Time Frame: up to 16 weeks from stent insertion

It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.

Secondary Outcomes

  • Evaluate the clinical success rate of SEMS insertion(up to 16 weeks from stent insertion)
  • Evaluate the technical success rate of SEMS insertion(up to 16 weeks from stent insertion)
  • Difference of insertion time between previous stent insertion and new designed stent(1 years)

Study Sites (1)

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