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Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Sponsor
Samsung Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01622803
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
24
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: parallel stent
  • Device: Y-stent (BONASTENT M-Hilar)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
Study Start Date :
Aug 1, 2011
Anticipated Primary Completion Date :
Aug 1, 2013
Anticipated Study Completion Date :
Aug 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The time taken to insert bilateral stent [After the ERCP procedure]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of 135-710

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kwang Hyuck Lee, Assistant Professor of Medicine, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT01622803
    Other Study ID Numbers:
    • KH0LEE
    First Posted:
    Jun 19, 2012
    Last Update Posted:
    Apr 26, 2016
    Last Verified:
    Apr 1, 2016
    Additional relevant MeSH terms:
    Bile Duct Neoplasms
    Jaundice
    Jaundice, Obstructive

    Study Results

    No Results Posted as of Apr 26, 2016