Back to resultsComparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
Primary Purpose
Bile Duct Neoplasm, Obstructive Jaundice
Status
Withdrawn
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
parallel stent
Y-stent (BONASTENT M-Hilar)
Sponsored by
About this trial
This is an interventional treatment trial for Bile Duct Neoplasm
Eligibility Criteria
Inclusion Criteria:
- age ≥ 18 years
- patient who have obstructive jaundice (bilirubin > 2.0mg/dl) due to hilar malignancy
Exclusion Criteria:
- patients with endoscopic retrograde cholangiogram is not possible
- bleeding tendency (PT INR > 1.5, platelet < 50,000)
- poor general condition (ECOG 3-4) or cardiopulmonary deterioration
- pregnancy
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
parallel stent
Y-stent
Arm Description
parallel stent insertion group
Y-stent insertion group
Outcomes
Primary Outcome Measures
The time taken to insert bilateral stent
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01622803
Brief Title
Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
Official Title
Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Patients enrollment problem
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.
Bilateral drainage is more physiologic and have more long patency than unilateral drainage.
There are two methods of bilateral drainage: Y-stent and side by side.
However there are no clinical data about comparing the effectiveness of these two methods.
Therefore the investigators want to compare the clinical outcomes of two methods:
Y-stent and side by side.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Neoplasm, Obstructive Jaundice
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
parallel stent
Arm Type
Active Comparator
Arm Description
parallel stent insertion group
Arm Title
Y-stent
Arm Type
Active Comparator
Arm Description
Y-stent insertion group
Intervention Type
Procedure
Intervention Name(s)
parallel stent
Other Intervention Name(s)
bilateral pig tail plastic stent
Intervention Description
bilateral parallel stent insertion (right and left side)
Intervention Type
Device
Intervention Name(s)
Y-stent (BONASTENT M-Hilar)
Other Intervention Name(s)
BONASTENT M-Hilar, Standard Sci Tech Inc, Seoul, South Korea
Intervention Description
Bilateral Y-stent insertion (stent in stent type)
Primary Outcome Measure Information:
Title
The time taken to insert bilateral stent
Time Frame
After the ERCP procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥ 18 years
patient who have obstructive jaundice (bilirubin > 2.0mg/dl) due to hilar malignancy
Exclusion Criteria:
patients with endoscopic retrograde cholangiogram is not possible
bleeding tendency (PT INR > 1.5, platelet < 50,000)
poor general condition (ECOG 3-4) or cardiopulmonary deterioration
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwang hyuck Lee, MD, phD
Organizational Affiliation
Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
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