Completed

A Newly Designed Conformable Uncovered Versus Covered Self-expandable Metallic Stent for Palliation of Malignant Gastric Outlet Obstruction: a Prospective, Randomized Multicenter Study

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What is being tested

uncovered D-type stent insertion

+ double-layered ComVi stent insertion

Device
Who is being recruted

Digestive System Diseases+1

+ Gastrointestinal Diseases

+ Stomach Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: April 2010
See protocol details

Summary

Principal SponsorAjou University School of Medicine
Last updated: April 24, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01839292
Principal SponsorAjou University School of Medicine
Last updated: April 24, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

89 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastrointestinal DiseasesStomach DiseasesGastric Outlet Obstruction

Criteria

3 inclusion criteria required to participate
a Karnofsky performance score of more than 30 (13)
adults 18 years of age or older
obstructive symptoms due to unresectable malignant GOO
5 exclusion criteria prevent from participating
a life expectancy of less than 1 month after SEMS insertion
history of a previous SEMS insertion
history of gastric surgery
severe comorbidities precluding the endoscopic procedure, such as cardiopulmonary disease, sepsis, and bleeding disorders
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Active Comparator
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Ajou University Hospital

Suwon, South KoreaOpen Ajou University Hospital in Google Maps
CompletedOne Study Center