- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01875549
Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent
Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Unilateral stent insertion group
the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
|
to use a LCD stent at an unilateral or bilateral stent insertion
Other Names:
to use ERCP for a stent insertion in an obstructive biliary tract
|
Active Comparator: Bilateral stent insertion group
the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
|
to use a LCD stent at an unilateral or bilateral stent insertion
Other Names:
to use ERCP for a stent insertion in an obstructive biliary tract
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stent patency
Time Frame: up to 1year
|
Participants will followed for the new obstruction(new jaundice) will occur.
|
up to 1year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
survival period
Time Frame: up to 1year
|
Participants will followed for 1year.
|
up to 1year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complication
Time Frame: up to 1year
|
Participants will followed after stent insertion and observe a complication rate between two groups.
|
up to 1year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kwang hyuck Lee, PhD, Division of Gastroenterology,Department of internal medicaion,samsung medical center,Sungkyunkwan University School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphatic Diseases
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Gallbladder Diseases
- Biliary Tract Diseases
- Biliary Tract Neoplasms
- Cholangiocarcinoma
- Lymphadenopathy
- Gallbladder Neoplasms
Other Study ID Numbers
- 2013-03-014-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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