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

April 27, 2016 updated by: Kwang Hyuck Lee, Samsung Medical Center

Prospective Study Comparing EUS Guided Biliary Drainage and ERCP With Stent Placement 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Irwon-dong, Gangnam-gu
      • Seoul, Irwon-dong, Gangnam-gu, Korea, Republic of, 135-710
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Children
  • Hilar obstruction
  • Active infection
  • Bleeding tendency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: ERCP guided stent insertion
Procedure: ERCP-guided stent insertion
ERCP guided stent insertion for malignant biliary obstruction
Other Names:
  • 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 Names:
  • EUS-guided metal stent insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stent patency (days)
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
complication rate
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

August 22, 2011

First Submitted That Met QC Criteria

August 22, 2011

First Posted (ESTIMATE)

August 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2011-03-101-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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