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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01862198
First Posted: May 24, 2013
Last Update Posted: December 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tea Jun Song, Inje University
  Purpose
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.

Condition Intervention Phase
Bile Duct Obstruction Disorder of Bile Duct Stent Neoplasms Device: EUS-guided biliary drainage with a hybrid metallic stent Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study on the Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent

Resource links provided by NLM:


Further study details as provided by Tea Jun Song, Inje University:

Primary Outcome Measures:
  • The stent patency rate [ Time Frame: Up to 48 weeks ]

Secondary Outcome Measures:
  • Patients' survival rate [ Time Frame: Up to 48 weeks ]
  • Complication rate related to the hybrid stents [ Time Frame: Up to 48 weeks ]

Enrollment: 27
Study Start Date: September 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hybrid metallic stent
Patients group who were inserted a hybrid metallic stent
Device: EUS-guided biliary drainage with a hybrid metallic stent
EUS-guided biliary drainage with a newly designed hybrid metallic stent

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862198


Locations
Korea, Republic of
Inje University Ilsan Paik Hospital
Koyang, Korea, Republic of, 411-706
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Inje University
Investigators
Study Chair: Sang Soo Lee, MD, PhD Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul , South Korea
  More Information

Responsible Party: Tea Jun Song, Assistant professor, Inje University
ClinicalTrials.gov Identifier: NCT01862198     History of Changes
Other Study ID Numbers: S2012-1819-0002
First Submitted: May 19, 2013
First Posted: May 24, 2013
Last Update Posted: December 2, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases