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ComVi and D-type Stent in Malignant GOO

NCT01839292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2013-04-24

No results posted yet for this study

Summary

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.

Conditions

  • Gastric Outlet Obstruction

Interventions

DEVICE

uncovered D-type stent insertion

DEVICE

double-layered ComVi stent insertion

Sponsors & Collaborators

  • National Cancer Center, Korea

    collaborator OTHER_GOV

  • Kyungpook National University Hospital

    collaborator OTHER

  • Hallym University

    collaborator OTHER

  • The Catholic University of Korea

    collaborator OTHER

  • Seoul National University

    collaborator OTHER

  • DongGuk University

    collaborator OTHER

  • Ajou University School of Medicine

    lead OTHER

Principal Investigators

  • Jin Hong Kim, M.D., Ph.D. · Ajou University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01839292 on ClinicalTrials.gov