Back to resultsComparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent
Primary Purpose
Obstruction of Biliary Tree, Cholangiocarcinoma, Hepatocellular Carcinoma
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stent insertion
Endoscopic retrograde cholangiopancreatoscopy(ERCP)
Sponsored by
About this trial
This is an interventional treatment trial for Obstruction of Biliary Tree
Eligibility Criteria
Inclusion Criteria:
- Age> 18
- diagnosis of malignancy in pathology or cytology
- jaundice(Total bilirubin)> 2.0 mg/dL
- Diagnosed malignant hilar invasion to CT or other image finding
Exclusion Criteria:
- bleeding tendency(INR>1.5)
- Pregnancy
- severe liver,kidney disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Unilateral stent insertion group
Bilateral stent insertion group
Arm Description
the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
Outcomes
Primary Outcome Measures
Stent patency
Participants will followed for the new obstruction(new jaundice) will occur.
Secondary Outcome Measures
survival period
Participants will followed for 1year.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01875549
Brief Title
Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent
Official Title
Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Why Stopped
no enrollment
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kwang Hyuck Lee
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Internal biliary drainage is an useful method for a control of jaundice and cholangitis to patients who had a malignant hilar obstruction due to hepatocellular carcinoma, cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy.
Bilateral biliary drainage is more physiologic but technically difficult to compared with unilateral biliary drainage specially related to conformability and flexibility between using stents.
There are no prospective clinical trials compared with these internal biliary drainage methods in hilar malignant obstruction using metal stent.
Therefore, the investigators want to compare the clinical outcome of two method: Unilateral biliary stent and Bilateral biliary stent
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstruction of Biliary Tree, Cholangiocarcinoma, Hepatocellular Carcinoma, Malignant Lymphadenopathy, Gall Bladder Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unilateral stent insertion group
Arm Type
Active Comparator
Arm Description
the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
Arm Title
Bilateral stent insertion group
Arm Type
Active Comparator
Arm Description
the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
Intervention Type
Device
Intervention Name(s)
stent insertion
Other Intervention Name(s)
Niti-S large cell D-type biliary stent [LCD]
Intervention Description
to use a LCD stent at an unilateral or bilateral stent insertion
Intervention Type
Procedure
Intervention Name(s)
Endoscopic retrograde cholangiopancreatoscopy(ERCP)
Intervention Description
to use ERCP for a stent insertion in an obstructive biliary tract
Primary Outcome Measure Information:
Title
Stent patency
Description
Participants will followed for the new obstruction(new jaundice) will occur.
Time Frame
up to 1year
Secondary Outcome Measure Information:
Title
survival period
Description
Participants will followed for 1year.
Time Frame
up to 1year
Other Pre-specified Outcome Measures:
Title
complication
Description
Participants will followed after stent insertion and observe a complication rate between two groups.
Time Frame
up to 1year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age> 18
diagnosis of malignancy in pathology or cytology
jaundice(Total bilirubin)> 2.0 mg/dL
Diagnosed malignant hilar invasion to CT or other image finding
Exclusion Criteria:
bleeding tendency(INR>1.5)
Pregnancy
severe liver,kidney disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwang hyuck Lee, PhD
Organizational Affiliation
Division of Gastroenterology,Department of internal medicaion,samsung medical center,Sungkyunkwan University School of Medicine
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent
We'll reach out to this number within 24 hrs