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

Samsung Medical Center

Status and phase: Completed; Phase 3; Phase 2

Conditions: Tumor Appearance of Biliary System Obstruction

Treatments: Procedure: ERCP-guided stent insertion; Procedure: EUS guided stent insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT01421836

2011-03-101-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• distal biliary obstruction due to malignant tumor
• unresectable tumor
• Jaundice

Exclusion criteria

• Children
• Hilar obstruction
• Active infection
• Bleeding tendency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

ERCP guided stent insertion

Active Comparator group

Treatment:

Procedure: ERCP-guided stent insertion

EUS guided stent insertion

Active Comparator group

Treatment:

Procedure: EUS guided stent insertion