ComVi and D-type Stent in Malignant GOO

NCT ID: NCT01839292

Last Updated: 2013-04-24

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Brief Summary

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Covered self-expandable metallic stents (SEMS) have been used to prevent tumor ingrowth, a common complication of uncovered SEMSs. However, they have revealed a high incidence of stent migration in patients with unresectable malignant gastric outlet obstruction (GOO). A conformable covered SEMS was introduced to overcome both stent migration and tumor ingrowth. The aims of this study were to evaluate the clinical outcomes of newly designed conformable covered and uncovered SEMS for palliation of malignant GOO.

Detailed Description

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Conditions

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Gastric Outlet Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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uncovered D-type stent

uncovered D-type stent, which effectively reduces stent migration, especially in malignant colorectal obstruction

Group Type ACTIVE_COMPARATOR

uncovered D-type stent insertion

Intervention Type DEVICE

double-layered ComVi stent

double-layered ComVi stent, which is a modified covered stent with an additional outer bare wire mesh to overcome both tumor ingrowth and stent migration

Group Type ACTIVE_COMPARATOR

double-layered ComVi stent insertion

Intervention Type DEVICE

Interventions

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uncovered D-type stent insertion

Intervention Type DEVICE

double-layered ComVi stent insertion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* adults 18 years of age or older
* obstructive symptoms due to unresectable malignant GOO
* a Karnofsky performance score of more than 30 (13)

Exclusion Criteria

* history of a previous SEMS insertion
* the presence of obstruction in the gastrointestinal tract excluding the gastric outlet
* severe comorbidities precluding the endoscopic procedure, such as cardiopulmonary disease, sepsis, and bleeding disorders
* a life expectancy of less than 1 month after SEMS insertion
* history of gastric surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role collaborator

Hallym University

OTHER

Sponsor Role collaborator

The Catholic University of Korea

OTHER

Sponsor Role collaborator

Seoul National University

OTHER

Sponsor Role collaborator

DongGuk University

OTHER

Sponsor Role collaborator

Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sun Gyo Lim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin Hong Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

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Ajou University Hospital

Suwon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AJIRB-DEV-DE4-10-009

Identifier Type: -

Identifier Source: org_study_id

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