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

Phase 2

Completed

• Conditions: Tumor Appearance of Biliary System Obstruction
• Interventions: Procedure: EUS guided stent insertion; Procedure: ERCP-guided stent insertion

• Registration Number: NCT01421836
• Lead Sponsor: Samsung Medical Center

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

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-08-22
• Study First Submitted QC: 2011-08-22
• Study First Posted: 2011-08-23
• Primary Completion: 2015-10
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• Children
• Hilar obstruction
• Active infection
• Bleeding tendency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS guided stent insertion	EUS guided stent insertion	-
ERCP guided stent insertion	ERCP-guided stent insertion	-

Primary Outcome Measures

Name	Time	Method
stent patency (days)	six months

Secondary Outcome Measures

Name	Time	Method
complication rate	six months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Irwon-dong, Gangnam-gu, Korea, Republic of