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

This study has been completed.
Information provided by (Responsible Party):
Tea Jun Song, Inje University Identifier:
First received: May 19, 2013
Last updated: November 29, 2013
Last verified: November 2013
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
Device: EUS-guided biliary drainage with a hybrid metallic stent
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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 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.

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

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
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Please refer to this study by its identifier: NCT01862198

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
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 Identifier: NCT01862198     History of Changes
Other Study ID Numbers: S2012-1819-0002
Study First Received: May 19, 2013
Last Updated: November 29, 2013

Additional relevant MeSH terms:
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases processed this record on May 23, 2017