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

Malignant Gastric Outlet Obstruction Clinical Trial

— SEMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02440724
• Other study ID #: 2014-0820
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2015
• Last updated: May 7, 2015
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: Asan Medical Center
• Contact: myungeun lee, BA
• Phone: +82-2-3010-7190
• Email: lme23[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Malignant Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Device:
• Winged stent (partially covered)
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.
• Winged stent (uncovered)
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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Evaluate the technical success rate of SEMS 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	No
Secondary	Evaluate the clinical success rate of SEMS 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	No
Secondary	Difference of insertion time between previous stent insertion and new designed stent		1 years	No