Tumor Appearance of Biliary System Obstruction
Conditions
Keywords
stent patency, EUS guided insertion, ERCP guided insertion
Brief summary
1. Purpose of the study -To compare stent patency and complication rate between endoscopic ultrasound (EUS) guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided stent insertion for malignant biliary obstruction 2. Subjects of the study -Patients who have biliary obstruction owing to malignant tumors 3. Methods of the study * Prospective randomized controlled study * Patients were enrolled randomly in two groups, EUS guided stent insertion group or ERCP guided stent insertion group * Patients will get assigned procedure (EUS guided stent insertion or ERCP guided stent insertion)for decompression of malignant biliary obstruction * After the procedure, regular follow up, blood test,and imaging test will be done to check sufficient biliary decompression,stent patency and complications.
Detailed description
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
Interventions
ERCP guided stent insertion for malignant biliary obstruction
EUS-guided stent insertion for malignant biliary obstruction
Sponsors
Study design
Eligibility
Inclusion criteria
* distal biliary obstruction due to malignant tumor * unresectable tumor * Jaundice
Exclusion criteria
* Children * Hilar obstruction * Active infection * Bleeding tendency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| stent patency (days) | six months |
Secondary
| Measure | Time frame |
|---|---|
| complication rate | six months |
Countries
South Korea