Back to resultsThe Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent
Primary Purpose
Bile Duct Obstruction, Disorder of Bile Duct Stent, Neoplasms
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EUS-guided biliary drainage with a hybrid metallic stent
Sponsored by
About this trial
This is an interventional treatment trial for Bile Duct Obstruction
Eligibility 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
Sites / Locations
- Inje University Ilsan Paik Hospital
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hybrid metallic stent
Arm Description
Patients group who were inserted a hybrid metallic stent
Outcomes
Primary Outcome Measures
The stent patency rate
Secondary Outcome Measures
Patients' survival rate
Complication rate related to the hybrid stents
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01862198
Brief Title
The Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent
Official Title
Pilot Study on the Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Obstruction, Disorder of Bile Duct Stent, Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hybrid metallic stent
Arm Type
Experimental
Arm Description
Patients group who were inserted a hybrid metallic stent
Intervention Type
Device
Intervention Name(s)
EUS-guided biliary drainage with a hybrid metallic stent
Intervention Description
EUS-guided biliary drainage with a newly designed hybrid metallic stent
Primary Outcome Measure Information:
Title
The stent patency rate
Time Frame
Up to 48 weeks
Secondary Outcome Measure Information:
Title
Patients' survival rate
Time Frame
Up to 48 weeks
Title
Complication rate related to the hybrid stents
Time Frame
Up to 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Soo Lee, MD, PhD
Organizational Affiliation
Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul , South Korea
Official's Role
Study Chair
Facility Information:
Facility Name
Inje University Ilsan Paik Hospital
City
Koyang
ZIP/Postal Code
411-706
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent
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