Prospective Study Comparing EUS vs ERCP Stent Insertion for Malignant Biliary Obstruction

Prospective Study Comparing EUS Guided Biliary Drainage and ERCP With Stent Placement for Malignant Biliary Obstruction

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.

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