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The Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent

NCT ID: NCT01862198

Last Updated: 2013-12-02

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

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-08-31

Brief Summary

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The purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.

Detailed Description

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Endoscopic ultrasound-guided biliary drainage with a fully covered metallic stent was a safe and effective method in patients with malignant biliary obstructions and had a comparatively long patency duration. Nevertheless, the significant rate of distal stent migration cannot be ignored, suggesting the need for a newly designed metallic stent for endoscopic ultrasound-guided biliary drainage.

Conditions

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Bile Duct Obstruction Disorder of Bile Duct Stent Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hybrid metallic stent

Patients group who were inserted a hybrid metallic stent

Group Type EXPERIMENTAL

EUS-guided biliary drainage with a hybrid metallic stent

Intervention Type DEVICE

EUS-guided biliary drainage with a newly designed hybrid metallic stent

Interventions

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EUS-guided biliary drainage with a hybrid metallic stent

EUS-guided biliary drainage with a newly designed hybrid metallic stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 20 years
* The presence of an unresectable malignant biliary obstruction
* Failed conventional ERCP stenting

Exclusion Criteria

* Age \< 20 years
* An inability to sedate the patient due to advanced heart or pulmonary diseases
* A lack of informed consent
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Tea Jun Song

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang Soo Lee, MD, PhD

Role: STUDY_CHAIR

Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul , South Korea

Locations

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Inje University Ilsan Paik Hospital

Koyang, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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S2012-1819-0002

Identifier Type: -

Identifier Source: org_study_id