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

Not Applicable

• Conditions: Malignant Gastric Outlet Obstruction
• Interventions: Device: Winged stent (partially covered); Device: Winged stent (uncovered)

• Registration Number: NCT02440724
• Lead Sponsor: Asan Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Status Verified: 2015-05
• Study First Submitted: 2015-05-04
• Study First Submitted QC: 2015-05-07
• Last Update Submitted: 2015-05-07
• Study First Posted: 2015-05-12
• Last Update Posted: 2015-05-12
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Gastric outlet obstruction symptom
2. Diagnosis of gastric outlet obstruction by radiologist or endoscopist
3. Gastric outlet obstruction by malignant disease
4. Aged over 19
5. Informed consent

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Exclusion Criteria

1. Gastric outlet obstruction by benign disease or infectious disease
2. Could not endoscopic intervention by poor general condition
3. Refusal of patient

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
winged stent group	Winged stent (uncovered)	participants who are assigned to winged-stent group will be treated with deployment of a winged stent(partially covered or uncovered SEMS).
winged stent group	Winged stent (partially covered)	participants who are assigned to winged-stent group will be treated with deployment of a winged stent(partially covered or uncovered SEMS).

Primary Outcome Measures

Name	Time	Method
Complication rate(stent migration and tumor ingrowth) of new designed winged stent	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 Outcome Measures

Name	Time	Method
Evaluate the clinical success rate of SEMS insertion	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.
Evaluate the technical success rate of SEMS insertion	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.
Difference of insertion time between previous stent insertion and new designed stent	1 years

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of