Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Stent patency
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Unilateral stent insertion group
the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
Intervention: stent insertion (Device)
Unilateral stent insertion group
the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
Intervention: Endoscopic retrograde cholangiopancreatoscopy(ERCP) (Procedure)
Bilateral stent insertion group
the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
Intervention: stent insertion (Device)
Bilateral stent insertion group
the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
Intervention: Endoscopic retrograde cholangiopancreatoscopy(ERCP) (Procedure)
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)
Investigators
Kwang Hyuck Lee
Professor
Samsung Medical Center