The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents
SEMS
1 other identifier
interventional
33
1 country
1
Brief Summary
The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 4, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 12, 2015
May 1, 2015
1.3 years
May 4, 2015
May 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complication rate(stent migration and tumor ingrowth) of new designed winged stent
It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.
up to 16 weeks from stent insertion
Secondary Outcomes (3)
Evaluate the technical success rate of SEMS insertion
up to 16 weeks from stent insertion
Evaluate the clinical 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 Arms (1)
winged stent group
EXPERIMENTALparticipants who are assigned to winged-stent group will be treated with deployment of a winged stent(partially covered or uncovered SEMS).
Interventions
A winged stent is a newly designed self-expandable metal stents(SEMS). Partially covered, or uncovered winged stent will be placed via the endoscopic intervention for malignant gastric outlet obstruction.
A winged stent is a newly designed self-expandable metal stents(SEMS). Partially covered, or uncovered winged stent will be placed via the endoscopic intervention for malignant gastric outlet obstruction.
Eligibility Criteria
You may qualify if:
- Gastric outlet obstruction symptom
- Diagnosis of gastric outlet obstruction by radiologist or endoscopist
- Gastric outlet obstruction by malignant disease
- Aged over 19
- Informed consent
You may not qualify if:
- Gastric outlet obstruction by benign disease or infectious disease
- Could not endoscopic intervention by poor general condition
- Refusal of patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, Songpa-gu, 138-736, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Ji Yong Ahn, Professor
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 4, 2015
First Posted
May 12, 2015
Study Start
August 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
May 12, 2015
Record last verified: 2015-05