Prospective Study Comparing EUS Guided Biliary Drainage and ERCP With Stent Placement for Malignant Biliary Obstruction
18 Years
N/A
Both
Tumor Appearance of Biliary System Obstruction
Trial Information
Prospective Study Comparing EUS Guided Biliary Drainage and ERCP With Stent Placement for Malignant Biliary Obstruction
1. Inclusion criteria 1) age: 18 - 80 2) a patients who had common bile duct dilatation
because of malignant distal common bile duct obstruction in radiologically 3)
Hyperbilirubinemia (total bilirubin >= 1.5 mg/dl) 4) inoperable state 5) a patients who
agree to join this study
2. Exclusion criteria 1) a patients who can not endure sedation 2) a patients with
bleeding tendency (PT > 1.5 INR, PLT < 50,000) 3) a patients with systemic infection 4)
a patients who had hilar obstruction
Inclusion Criteria:
- distal biliary obstruction due to malignant tumor
- unresectable tumor
- Jaundice
Exclusion Criteria:
- Children
- Hilar obstruction
- Active infection
- Bleeding tendency
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
stent patency (days)
Outcome Time Frame:
six months
Safety Issue:
No
Principal Investigator
Kwanghyuck Lee, MD, phD
Investigator Role:
Study Director
Investigator Affiliation:
Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Authority:
South Korea: Institutional Review Board
Study ID:
2011-03-101-001
NCT ID:
NCT01421836
Start Date:
May 2011
Completion Date:
August 2014
Related Keywords:
- Tumor Appearance of Biliary System Obstruction
- stent patency
- EUS guided insertion
- ERCP guided insertion
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