Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction

NCT ID: NCT02156505

Last Updated: 2014-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Outlet Obstruction Due to Malignancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DoubleBare stent

Placement of double bare stent

Group Type EXPERIMENTAL

placement of double bare stent

Intervention Type PROCEDURE

DoubleBare stent

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

placement of double bare stent

Intervention Type PROCEDURE

DoubleBare stent

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stent research group, Korean Society of Gastrointestinal Endoscopy, Korea

UNKNOWN

Sponsor Role collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chan Gyoo Kim

Senior scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chan G Kim, M.D.

Role: CONTACT

+82-31-920-1620

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chan G Kim, M.D.

Role: primary

+82-31-920-1620

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCCCTSMD12009

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

SEMS and Gastroenterostomy
NCT04599179 COMPLETED