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Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction

Sponsor
Samsung Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02255669
Collaborator
(none)
106
Enrollment
1
Location
2
Arms
24
Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.

Condition or Disease Intervention/Treatment Phase
  • Device: partially covered SEMS
  • Device: fully covered SEMS
 N/A

Detailed Description

Endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of chemotherapy. Although SEMSs have been reported to be superior to plastic stents in terms of stent patency, they still have some debatable issues ; in uncovered SEMS, stent occlusion due to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem, whereas covered SEMSs are prone to migration.

The aim of the current study is to compare the duration of stent patency between partially covered and fully covered SEMS as a primary objective, and investigate overall patient survival, stent occlusion rate, and incidence of adverse events including stent dysfunction as secondary objectives.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison Between Fully Covered and Partially Covered Self-expandable Metal Stents With Anti-migration System for Malignant Distal Biliary Obstruction
Study Start Date :
Oct 1, 2014
Anticipated Primary Completion Date :
Oct 1, 2016
Anticipated Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: partially covered SEMS

Deployment of Partially covered biliary self expandable metal stent

Device: partially covered SEMS
Used for palliation of inoperable malignant distal bile duct obstruction.
Other Names:
  • Insertion of partially covered SEMS (PCSEMS)

    		•
    Active Comparator: fully covered SEMS

    Deployment of Fully covered biliary self expandable metal stent

    Device: fully covered SEMS
    Used for palliation of inoperable malignant distal bile duct obstruction.
    Other Names:
  • Insertion of fully covered SEMS (FCSEMS)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. duration of stent patency [From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months]

    Secondary Outcome Measures

    1. overall survival [From the date of randomization until the date of death from any cause, assessed upto 12 months]

    2. stent occlusion rate [From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months]

    3. stent related complication [From the date of randomization until the date of first documented stent related complication, assessed up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 1.> 19years 2.malignant biliary obstruction, 2 cm distal to hilum 3.unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal
    Exclusion Criteria:
    • 1.history of biliary surgery except cholecystectomy 2.history of SEMS placement 3.coagulopathy (INR>1.5, Platelet<50000) 4.expected survival > 3 months based on Karnofsky performance score 5.duodenal stricture

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    • Principal Investigator: Jong Kyun Lee, M.D., Ph.D., Samsung Medical Cencer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT02255669
    Other Study ID Numbers:
    • 2014-07-187-001
    First Posted:
    Oct 2, 2014
    Last Update Posted:
    Feb 12, 2015
    Last Verified:
    Sep 1, 2014
    Additional relevant MeSH terms:
    Biliary Tract Neoplasms

    Study Results

    No Results Posted as of Feb 12, 2015