- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02440724
The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents (SEMS)
May 7, 2015 updated by: Ji Yong Ahn, Asan Medical Center
The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Songpa-gu
-
Seoul, Songpa-gu, Korea, Republic of, 138-736
- Recruiting
- Asan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: winged stent group
participants who are assigned to winged-stent group will be treated with deployment of a winged stent(partially covered or uncovered SEMS).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 16 weeks from stent insertion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the technical success rate of SEMS insertion
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.
|
up to 16 weeks from stent insertion
|
Evaluate the clinical success rate of SEMS insertion
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.
|
up to 16 weeks from stent insertion
|
Difference of insertion time between previous stent insertion and new designed stent
Time Frame: 1 years
|
1 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ji Yong Ahn, Professor, Asan Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
May 4, 2015
First Submitted That Met QC Criteria
May 7, 2015
First Posted (Estimate)
May 12, 2015
Study Record Updates
Last Update Posted (Estimate)
May 12, 2015
Last Update Submitted That Met QC Criteria
May 7, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-0820 (Other Identifier: M D Anderson Cancer Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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