<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02255669</url>
  </required_header>
  <id_info>
    <org_study_id>2014-07-187-001</org_study_id>
    <nct_id>NCT02255669</nct_id>
  </id_info>
  <brief_title>Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction</brief_title>
  <official_title>Comparison Between Fully Covered and Partially Covered Self-expandable Metal Stents With Anti-migration System for Malignant Distal Biliary Obstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the duration of stent patency between partially&#xD;
      covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endoscopic stent placement has been used as a principle palliative method in patients with&#xD;
      unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief&#xD;
      from obstructive jaundice, improving the quality of life, and allowing the maintenance of&#xD;
      chemotherapy. Although SEMSs have been reported to be superior to plastic stents in terms of&#xD;
      stent patency, they still have some debatable issues ; in uncovered SEMS, stent occlusion due&#xD;
      to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem,&#xD;
      whereas covered SEMSs are prone to migration.&#xD;
&#xD;
      The aim of the current study is to compare the duration of stent patency between partially&#xD;
      covered and fully covered SEMS as a primary objective, and investigate overall patient&#xD;
      survival, stent occlusion rate, and incidence of adverse events including stent dysfunction&#xD;
      as secondary objectives.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">October 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>duration of stent patency</measure>
    <time_frame>From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>From the date of randomization until the date of death from any cause, assessed upto 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stent occlusion rate</measure>
    <time_frame>From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stent related complication</measure>
    <time_frame>From the date of randomization until the date of first documented stent related complication, assessed up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">106</enrollment>
  <condition>Biliary Tract Neoplasms</condition>
  <arm_group>
    <arm_group_label>partially covered SEMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Deployment of Partially covered biliary self expandable metal stent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fully covered SEMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Deployment of Fully covered biliary self expandable metal stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>partially covered SEMS</intervention_name>
    <description>Used for palliation of inoperable malignant distal bile duct obstruction.</description>
    <arm_group_label>partially covered SEMS</arm_group_label>
    <other_name>Insertion of partially covered SEMS (PCSEMS)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>fully covered SEMS</intervention_name>
    <description>Used for palliation of inoperable malignant distal bile duct obstruction.</description>
    <arm_group_label>fully covered SEMS</arm_group_label>
    <other_name>Insertion of fully covered SEMS (FCSEMS)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.&gt; 19years 2.malignant biliary obstruction, 2 cm distal to hilum 3.unsuitable for&#xD;
             curative surgical resection owing to metastasis, locally advanced stage, high&#xD;
             operation risk, or patient's refusal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.history of biliary surgery except cholecystectomy 2.history of SEMS placement&#xD;
             3.coagulopathy (INR&gt;1.5, Platelet&lt;50000) 4.expected survival &gt; 3 months based on&#xD;
             Karnofsky performance score 5.duodenal stricture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong Kyun Lee, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Cencer</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jong Kyun Lee, M.D., Ph.D.</last_name>
    <phone>82-2-3410-3409</phone>
    <email>leejk@skku.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Cencer</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jong-Kyun Lee, M.D., Ph.D.</last_name>
      <phone>81-2-3410-3409</phone>
      <email>jongk.lee@samsung.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>February 10, 2015</last_update_submitted>
  <last_update_submitted_qc>February 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Biliary Tract Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02255669
org study id: 2014-07-187-001
nct id: NCT02255669
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: duration of stent patency
time frame: From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months
measure: overall survival
time frame: From the date of randomization until the date of death from any cause, assessed upto 12 months
measure: stent occlusion rate
time frame: From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months
measure: stent related complication
time frame: From the date of randomization until the date of first documented stent related complication, assessed up to 12 months
arm group label: partially covered SEMS
arm group type: Active Comparator
description: Deployment of Partially covered biliary self expandable metal stent
arm group label: fully covered SEMS
arm group type: Active Comparator
description: Deployment of Fully covered biliary self expandable metal stent
intervention type: Device
intervention name: partially covered SEMS
description: Used for palliation of inoperable malignant distal bile duct obstruction.
arm group label: partially covered SEMS
other name: Insertion of partially covered SEMS (PCSEMS)
intervention type: Device
intervention name: fully covered SEMS
description: Used for palliation of inoperable malignant distal bile duct obstruction.
arm group label: fully covered SEMS
other name: Insertion of fully covered SEMS (FCSEMS)
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Jong Kyun Lee, M.D., Ph.D.
role: Principal Investigator
affiliation: Samsung Medical Cencer
last name: Jong Kyun Lee, M.D., Ph.D.
phone: 82-2-3410-3409
email: leejk@skku.edu
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Biliary Tract Neoplasms