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

Sponsor
Kwang Hyuck Lee (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01875549
Collaborator
(none)
0
Enrollment
2
Arms
36
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: stent insertion
  • Procedure: Endoscopic retrograde cholangiopancreatoscopy(ERCP)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent
Study Start Date :
May 1, 2013
Anticipated Primary Completion Date :
May 1, 2015
Anticipated Study Completion Date :
May 1, 2016

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Stent patency [up to 1year]

      Participants will followed for the new obstruction(new jaundice) will occur.

    Secondary Outcome Measures

    1. survival period [up to 1year]

      Participants will followed for 1year.

    Other Outcome Measures

    1. complication [up to 1year]

      Participants will followed after stent insertion and observe a complication rate between two groups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kwang Hyuck Lee, Professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT01875549
    Other Study ID Numbers:
    • 2013-03-014-002
    First Posted:
    Jun 12, 2013
    Last Update Posted:
    Apr 26, 2016
    Last Verified:
    Apr 1, 2016
    Additional relevant MeSH terms:
    Cholangiocarcinoma
    Gallbladder Neoplasms
    Lymphadenopathy

    Study Results

    No Results Posted as of Apr 26, 2016