Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstruction of Biliary Tree
- Sponsor
- Kwang Hyuck Lee
- Primary Endpoint
- Stent patency
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
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
Investigators
Kwang Hyuck Lee
Professor
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Stent patency
Time Frame: up to 1year
Participants will followed for the new obstruction(new jaundice) will occur.
Secondary Outcomes
- survival period(up to 1year)