Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent

April 24, 2016 updated by: Kwang Hyuck Lee

Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent

Internal biliary drainage is an useful method for a control of jaundice and cholangitis to patients who had a malignant hilar obstruction due to hepatocellular carcinoma, cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy.

Bilateral biliary drainage is more physiologic but technically difficult to compared with unilateral biliary drainage specially related to conformability and flexibility between using stents.

There are no prospective clinical trials compared with these internal biliary drainage methods in hilar malignant obstruction using metal stent.

Therefore, the investigators want to compare the clinical outcome of two method: Unilateral biliary stent and Bilateral biliary stent

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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:

  • Age> 18
  • diagnosis of malignancy in pathology or cytology
  • jaundice(Total bilirubin)> 2.0 mg/dL
  • Diagnosed malignant hilar invasion to CT or other image finding

Exclusion Criteria:

  • bleeding tendency(INR>1.5)
  • Pregnancy
  • severe liver,kidney disease

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Unilateral stent insertion group
the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
Device: stent insertion
to use a LCD stent at an unilateral or bilateral stent insertion
Other Names:
  • Niti-S large cell D-type biliary stent [LCD]
Procedure: Endoscopic retrograde cholangiopancreatoscopy(ERCP)
to use ERCP for a stent insertion in an obstructive biliary tract
Active Comparator: Bilateral stent insertion group
the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
Device: stent insertion
to use a LCD stent at an unilateral or bilateral stent insertion
Other Names:
  • Niti-S large cell D-type biliary stent [LCD]
Procedure: Endoscopic retrograde cholangiopancreatoscopy(ERCP)
to use ERCP for a stent insertion in an obstructive biliary tract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent patency
Time Frame: up to 1year
Participants will followed for the new obstruction(new jaundice) will occur.
up to 1year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival period
Time Frame: up to 1year
Participants will followed for 1year.
up to 1year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
complication
Time Frame: up to 1year
Participants will followed after stent insertion and observe a complication rate between two groups.
up to 1year

Collaborators and Investigators

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

Sponsor

Kwang Hyuck Lee

Investigators

  • Study Director: Kwang hyuck Lee, PhD, Division of Gastroenterology,Department of internal medicaion,samsung medical center,Sungkyunkwan University School of Medicine

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, 2013

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (Estimate)

June 12, 2013

Study Record Updates

Last Update Posted (Estimate)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 24, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-03-014-002

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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