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OpenTrials
Completed

NCT Number: NCT01421836

Prospective Study Comparing EUS vs ERCP Stent Insertion 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.

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Key information

Conditions

Tumor Appearance of Biliary System Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Samsung Medical Center

Seoul, Irwon-dong, Gangnam-gu, 135-710, South Korea

About this study

  • 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
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children
  • Hilar obstruction
  • Active infection
  • Bleeding tendency

Treatment and study plan

ERCP-guided stent insertion

Procedure

ERCP guided stent insertion for malignant biliary obstruction

Other names: ERCP-guided metal stent insertion

EUS guided stent insertion

Procedure

EUS-guided stent insertion for malignant biliary obstruction

Other names: EUS-guided metal stent insertion

Primary outcomes

  1. stent patency (days)

    Time frame: six months

Secondary outcomes

  1. complication rate

    Time frame: six months

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Aug 23, 2011
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.