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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014