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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421836
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : April 28, 2016
Information provided by (Responsible Party):
Kwang Hyuck Lee, 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.

Condition or disease Intervention/treatment Phase
Tumor Appearance of Biliary System Obstruction Procedure: ERCP-guided stent insertion Procedure: EUS guided stent insertion Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study Comparing EUS Guided Biliary Drainage and ERCP With Stent Placement for Malignant Biliary Obstruction
Study Start Date : May 2011
Actual Primary Completion Date : October 2015
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Active Comparator: ERCP guided stent insertion Procedure: ERCP-guided stent insertion
ERCP guided stent insertion for malignant biliary obstruction
Other Name: ERCP-guided metal stent insertion
Active Comparator: EUS guided stent insertion Procedure: EUS guided stent insertion
EUS-guided stent insertion for malignant biliary obstruction
Other Name: EUS-guided metal stent insertion

Primary Outcome Measures :
  1. stent patency (days) [ Time Frame: six months ]

Secondary Outcome Measures :
  1. complication rate [ Time Frame: six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Children
  • Hilar obstruction
  • Active infection
  • Bleeding tendency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421836

Korea, Republic of
Samsung Medical Center
Seoul, Irwon-dong, Gangnam-gu, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Study Director: Kwanghyuck Lee, MD, phD Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Responsible Party: Kwang Hyuck Lee, Professor of Department of Medicine,Samsung Medical Center,Sungkyunkwan University School of Medicine, Samsung Medical Center Identifier: NCT01421836     History of Changes
Other Study ID Numbers: 2011-03-101-001
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016

Keywords provided by Kwang Hyuck Lee, Samsung Medical Center:
stent patency
EUS guided insertion
ERCP guided insertion