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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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01421836
Enrollment
30
Registered
2011-08-23
Start date
2011-05-31
Completion date
2016-03-31
Last updated
2016-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumor Appearance of Biliary System Obstruction

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

PROCEDUREERCP-guided stent insertion

ERCP guided stent insertion for malignant biliary obstruction

PROCEDUREEUS guided stent insertion

EUS-guided stent insertion for malignant biliary obstruction

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Children * Hilar obstruction * Active infection * Bleeding tendency

Design outcomes

Primary

MeasureTime frame
stent patency (days)six months

Secondary

MeasureTime frame
complication ratesix months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026