NCT02156505

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

June 5, 2014

Status Verified

June 1, 2014

Enrollment Period

2.5 years

First QC Date

June 2, 2014

Last Update Submit

June 4, 2014

Conditions

Gastric Outlet Obstruction Due to Malignancy

Keywords

stentgastric outlet obstructionrestenosis

Outcome Measures

Primary Outcomes (1)

  • The patency rate at 8 weeks after placement.

    8 weeks

Secondary Outcomes (3)

  • Technical and clinical success rates

    up to 8 weeks

  • re-stenosis rate

    8 weeks

  • migration rate

    8 weeks

Study Arms (1)

DoubleBare stent

EXPERIMENTAL

Placement of double bare stent

Procedure: placement of double bare stentDevice: DoubleBare stent

Interventions

placement of double bare stentPROCEDURE
DoubleBare stent
DoubleBare stentDEVICE
DoubleBare stent

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

MeSH Terms

Conditions

Gastric Outlet Obstruction

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Chan G Kim, M.D.

CONTACT

+82-31-920-1620glse@chol.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior scientist

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 5, 2014

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

June 5, 2014

Record last verified: 2014-06

Locations

KR(1)