Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction

June 4, 2014 updated by: Chan Gyoo Kim, National Cancer Center, Korea

Phase IV Study of Double Bare Self-expandable Metallic Stent for Malignant Gastric Outlet Obstruction

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

49

Phase

  • Phase 4

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

  • Korea, Republic of
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 410-769
        • Recruiting
        • National Cancer Center
        • Contact:
          • Chan G Kim, M.D.
          • Phone Number: +82-31-920-1620
          • Email: glse@chol.com
        • Principal Investigator:
          • Chan G Kim, M.D.

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: DoubleBare stent
Placement of double bare stent
Procedure: placement of double bare stent
Device: DoubleBare stent

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Collaborators

Stent research group, Korean Society of Gastrointestinal Endoscopy, Korea

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

January 1, 2013

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

June 2, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTSMD12009

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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