Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

April 24, 2016 updated by: Kwang Hyuck Lee, Samsung Medical Center

Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.

Bilateral drainage is more physiologic and have more long patency than unilateral drainage.

There are two methods of bilateral drainage: Y-stent and side by side.

However there are no clinical data about comparing the effectiveness of these two methods.

Therefore the investigators want to compare the clinical outcomes of two methods:

Y-stent and side by side.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • 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

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 years
  • patient who have obstructive jaundice (bilirubin > 2.0mg/dl) due to hilar malignancy

Exclusion Criteria:

  • patients with endoscopic retrograde cholangiogram is not possible
  • bleeding tendency (PT INR > 1.5, platelet < 50,000)
  • poor general condition (ECOG 3-4) or cardiopulmonary deterioration
  • pregnancy

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: parallel stent
parallel stent insertion group
Procedure: parallel stent
bilateral parallel stent insertion (right and left side)
Other Names:
  • bilateral pig tail plastic stent
ACTIVE_COMPARATOR: Y-stent
Y-stent insertion group
Device: Y-stent (BONASTENT M-Hilar)
Bilateral Y-stent insertion (stent in stent type)
Other Names:
  • BONASTENT M-Hilar, Standard Sci Tech Inc, Seoul, South Korea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The time taken to insert bilateral stent
Time Frame: After the ERCP procedure
After the ERCP procedure

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Investigators

  • Study Director: Kwang hyuck Lee, MD, phD, Division of Gastroenterology, Department of Internal Medicine, 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

August 1, 2011

Primary Completion (ANTICIPATED)

August 1, 2013

Study Completion (ANTICIPATED)

August 1, 2013

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (ESTIMATE)

June 19, 2012

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

  • KH0LEE

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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