ComVi and D-type Stent in Malignant GOO

April 22, 2013 updated by: Sun Gyo Lim, Ajou University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

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

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: uncovered D-type stent
uncovered D-type stent, which effectively reduces stent migration, especially in malignant colorectal obstruction
Device: uncovered D-type stent insertion
ACTIVE_COMPARATOR: 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
Device: double-layered ComVi stent insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the stent patency time from stent insertion to restenosis due to stent malfunction or death
Time Frame: Up to 1 years
Up to 1 years

Secondary Outcome Measures

Outcome Measure
Time Frame
stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate
Time Frame: up to 1 years
up to 1 years

Collaborators and Investigators

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

Sponsor

Ajou University School of Medicine

Collaborators

National Cancer Center, Korea
Seoul National University
Kyungpook National University Hospital
The Catholic University of Korea
DongGuk University
Hallym University

Investigators

  • Principal Investigator: Jin Hong Kim, M.D., Ph.D., Ajou University School of Medicine

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

April 1, 2010

Primary Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (ESTIMATE)

April 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 24, 2013

Last Update Submitted That Met QC Criteria

April 22, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-DEV-DE4-10-009

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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