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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kwang Hyuck Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01421836
First received: August 22, 2011
Last updated: April 27, 2016
Last verified: April 2016
  Purpose
  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 Intervention Phase
Tumor Appearance of Biliary System Obstruction
Procedure: ERCP-guided stent insertion
Procedure: EUS guided stent insertion
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Study Comparing EUS Guided Biliary Drainage and ERCP With Stent Placement for Malignant Biliary Obstruction

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • stent patency (days) [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complication rate [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2011
Study Completion Date: March 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Children
  • Hilar obstruction
  • Active infection
  • Bleeding tendency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421836

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

Responsible Party: Kwang Hyuck Lee, Professor of Department of Medicine,Samsung Medical Center,Sungkyunkwan University School of Medicine, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01421836     History of Changes
Other Study ID Numbers: 2011-03-101-001 
Study First Received: August 22, 2011
Last Updated: April 27, 2016
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
stent patency
EUS guided insertion
ERCP guided insertion

ClinicalTrials.gov processed this record on May 26, 2016