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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tea Jun Song, Inje University
ClinicalTrials.gov Identifier:
NCT01862198
First received: May 19, 2013
Last updated: November 29, 2013
Last verified: November 2013
  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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients' survival rate [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  • Complication rate related to the hybrid stents [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tea Jun Song, Assistant professor, Inje University
ClinicalTrials.gov Identifier: NCT01862198     History of Changes
Other Study ID Numbers: S2012-1819-0002
Study First Received: May 19, 2013
Last Updated: November 29, 2013
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014