Outcome Study of Double Bare Stent for Malignant Gastric... | NCT02156505

Studies
Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction

NCT02156505

Sponsor

National Cancer Center, Korea

Status

Unknown status

Last Update Posted

Jun 5, 2014Estimated

Enrollment

49Estimated

Phase

Phase 4

Conditions

Gastric Outlet Obstruction Due to Malignancy

Interventions

placement of double bare stent
DoubleBare stent

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jul 2015Estimated

Completion Date

Jul 2015Estimated

First Submitted Date

Jun 2, 2014

First Submission Date that Met QC Criteria

Jun 4, 2014

First Posted Date

Jun 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2014

Last Update Posted Date

Jun 5, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chan Gyoo Kim, Senior scientist, National Cancer Center, KoreaPrincipal Investigator

Lead Sponsor

National Cancer Center, KoreaOTHER_GOV

Collaborators

Name	Class
Stent research group, Korean Society of Gastrointestinal Endoscopy, Korea	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Self-expandable metallic stents provide effective palliation of malignant gastric outlet obstruction. However, uncovered stent are often associated with re-stenosis caused by tumor in-growth through the stent mesh. The Self-expandable metallic stents which has the design of smaller wire mesh size (double bare stent) were developed and used in Korea. This new design was developed to minimize the re-stenosis of uncovered stent, but the outcome is unknown. The end point of this study is the 8-weeks patency rate after placement of double bare as well as technical and clinical success rates.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DoubleBare stent	Experimental	Placement of double bare stent	Procedure: placement of double bare stent Device: DoubleBare stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placement of double bare stent	Procedure		DoubleBare stent
DoubleBare stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The patency rate at 8 weeks after placement.		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Technical and clinical success rates		up to 8 weeks
re-stenosis rate		8 weeks
migration rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Malignant gastric outlet obstruction
Symptoms compatible with gastric outlet obstruction
An inoperable condition because of extent of disease or patient's conditions

Exclusion Criteria:

History of enteral stent placement, undergone gastric surgery.
Additional small bowel stenosis distal to gastric outlet obstruction.
Refuse to be enrolled to study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chan G Kim, M.D.	Contact	+82-31-920-1620		glse@chol.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center	Recruiting	Goyang-si	Gyeonggi-do	410-769	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D017219	Gastric Outlet Obstruction

Ancestor Terms

ID	Term
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided