<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/NCT01733342</url>
  </required_header>
  <id_info>
    <org_study_id>HP2012-k</org_study_id>
    <nct_id>NCT01733342</nct_id>
  </id_info>
  <brief_title>Single-center Randomized Trial for Comparison of Performance Between Domestic and Imported Chemoport</brief_title>
  <acronym>SiCDIP</acronym>
  <official_title>Single-center Randomized Trial for Comparison of Performance Between Domestic and Imported Chemoport</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the performance of domestic chemoport and imported chemoport&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      chemoport implantation was done by two investigator Chemoport type was randomly rendered.&#xD;
      Domestic chemoport(Human port) and imported chemoport (Celsite) were used. chemoport function&#xD;
      will be followed up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>function of chemoport</measure>
    <time_frame>6 months</time_frame>
    <description>Whether or not chemoport function is intact will be assessed. Chemoport function will be rendered as intact when chemotherapeutic agent is well infused through the chemoport. Chemoport function will be rendered as not intact when chemotherapeutic agent could be infused through the chemoport.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>infection</measure>
    <time_frame>6 months</time_frame>
    <description>If infection related with chemoport develop during 6 month follow-up, infection will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin dehiscence</measure>
    <time_frame>6 months</time_frame>
    <description>If skin dehiscence related with chemoport develop during 6 month follow-up, it will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>deep vein thrombosis</measure>
    <time_frame>6 months</time_frame>
    <description>If deep vein thrombosis related with chemoport develop during 6 month follow-up, it will be recorded. Deep vein thrombosis can be develop in the jugular vein which is access route.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrin sheath</measure>
    <time_frame>6 months</time_frame>
    <description>If fibrin sheath around chemoport catheter develop during 6 month follow-up, it will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Celsite</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients received celsite chemoport implantation under local anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Humanport</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients received Humanport chemoport implantation under local anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Celsite chemoport implantation</intervention_name>
    <description>Celsite chemoport implantation was done under local anesthesia, at anterior chest wall, under ultrasound guidance</description>
    <arm_group_label>Celsite</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>local anesthesia</intervention_name>
    <description>chemoport implantation will be done under local anesthesia using lidocaine.</description>
    <arm_group_label>Celsite</arm_group_label>
    <arm_group_label>Humanport</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Humanport chemoport implantation</intervention_name>
    <description>Humanport chemoport implantation was done under local anesthesia, at anterior chest wall, under ultrasound guidance</description>
    <arm_group_label>Humanport</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who will receive chemotherapy via implantable port&#xD;
&#xD;
          -  age &gt;20 years&#xD;
&#xD;
          -  expected life time &gt; 6 months&#xD;
&#xD;
          -  lab test (platelet&gt;50K, PT INR &lt;2.0)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  performance status &gt;2&#xD;
&#xD;
          -  brain metastasis&#xD;
&#xD;
          -  expected life time less than 6 months&#xD;
&#xD;
          -  age less than 20 years&#xD;
&#xD;
          -  active infection&#xD;
&#xD;
          -  severe heart dysfunction&#xD;
&#xD;
          -  recent myocardial infarct&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyo-Cheol Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Niederhuber JE, Ensminger W, Gyves JW, Liepman M, Doan K, Cozzi E. Totally implanted venous and arterial access system to replace external catheters in cancer treatment. Surgery. 1982 Oct;92(4):706-12.</citation>
    <PMID>7123491</PMID>
  </reference>
  <reference>
    <citation>Ahn SJ, Kim HC, Chung JW, An SB, Yin YH, Jae HJ, Park JH. Ultrasound and fluoroscopy-guided placement of central venous ports via internal jugular vein: retrospective analysis of 1254 port implantations at a single center. Korean J Radiol. 2012 May-Jun;13(3):314-23. doi: 10.3348/kjr.2012.13.3.314. Epub 2012 Apr 17.</citation>
    <PMID>22563269</PMID>
  </reference>
  <reference>
    <citation>Teichgraber UK, Kausche S, Nagel SN, Gebauer B. Outcome analysis in 3,160 implantations of radiologically guided placements of totally implantable central venous port systems. Eur Radiol. 2011 Jun;21(6):1224-32. doi: 10.1007/s00330-010-2045-7. Epub 2011 Jan 5.</citation>
    <PMID>21207035</PMID>
  </reference>
  <reference>
    <citation>Teichgraber UK, Kausche S, Nagel SN. Evaluation of radiologically implanted central venous port systems explanted due to complications. J Vasc Access. 2011 Oct-Dec;12(4):306-12. doi: 10.5301/JVA.2011.7739.</citation>
    <PMID>21534232</PMID>
  </reference>
  <reference>
    <citation>Biffi R, de Braud F, Orsi F, Pozzi S, Mauri S, Goldhirsch A, Nole F, Andreoni B. Totally implantable central venous access ports for long-term chemotherapy. A prospective study analyzing complications and costs of 333 devices with a minimum follow-up of 180 days. Ann Oncol. 1998 Jul;9(7):767-73. doi: 10.1023/a:1008392423469.</citation>
    <PMID>9739444</PMID>
  </reference>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>December 2, 2013</last_update_submitted>
  <last_update_submitted_qc>December 2, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 4, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Hyo-Cheol Kim</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT01733342
org study id: HP2012-k
nct id: NCT01733342
lead sponsor: 
has dmc: Yes
To compare the performance of domestic chemoport and imported chemoport
chemoport implantation was done by two investigator Chemoport type was randomly rendered.
      Domestic chemoport(Human port) and imported chemoport (Celsite) were used. chemoport function
      will be followed up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: function of chemoport
time frame: 6 months
description: Whether or not chemoport function is intact will be assessed. Chemoport function will be rendered as intact when chemotherapeutic agent is well infused through the chemoport. Chemoport function will be rendered as not intact when chemotherapeutic agent could be infused through the chemoport.
measure: infection
time frame: 6 months
description: If infection related with chemoport develop during 6 month follow-up, infection will be recorded.
measure: Skin dehiscence
time frame: 6 months
description: If skin dehiscence related with chemoport develop during 6 month follow-up, it will be recorded.
measure: deep vein thrombosis
time frame: 6 months
description: If deep vein thrombosis related with chemoport develop during 6 month follow-up, it will be recorded. Deep vein thrombosis can be develop in the jugular vein which is access route.
measure: Fibrin sheath
time frame: 6 months
description: If fibrin sheath around chemoport catheter develop during 6 month follow-up, it will be recorded.
arm group label: Celsite
arm group type: Active Comparator
description: patients received celsite chemoport implantation under local anesthesia
arm group label: Humanport
arm group type: Experimental
description: patients received Humanport chemoport implantation under local anesthesia
intervention type: Device
intervention name: Celsite chemoport implantation
description: Celsite chemoport implantation was done under local anesthesia, at anterior chest wall, under ultrasound guidance
arm group label: Celsite
intervention type: Procedure
intervention name: local anesthesia
description: chemoport implantation will be done under local anesthesia using lidocaine.
arm group label: Celsite
arm group label: Humanport
intervention type: Device
intervention name: Humanport chemoport implantation
description: Humanport chemoport implantation was done under local anesthesia, at anterior chest wall, under ultrasound guidance
arm group label: Humanport
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hyo-Cheol Kim, MD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
citation: Niederhuber JE, Ensminger W, Gyves JW, Liepman M, Doan K, Cozzi E. Totally implanted venous and arterial access system to replace external catheters in cancer treatment. Surgery. 1982 Oct;92(4):706-12.
PMID: 7123491
citation: Ahn SJ, Kim HC, Chung JW, An SB, Yin YH, Jae HJ, Park JH. Ultrasound and fluoroscopy-guided placement of central venous ports via internal jugular vein: retrospective analysis of 1254 port implantations at a single center. Korean J Radiol. 2012 May-Jun;13(3):314-23. doi: 10.3348/kjr.2012.13.3.314. Epub 2012 Apr 17.
PMID: 22563269
citation: Teichgraber UK, Kausche S, Nagel SN, Gebauer B. Outcome analysis in 3,160 implantations of radiologically guided placements of totally implantable central venous port systems. Eur Radiol. 2011 Jun;21(6):1224-32. doi: 10.1007/s00330-010-2045-7. Epub 2011 Jan 5.
PMID: 21207035
citation: Teichgraber UK, Kausche S, Nagel SN. Evaluation of radiologically implanted central venous port systems explanted due to complications. J Vasc Access. 2011 Oct-Dec;12(4):306-12. doi: 10.5301/JVA.2011.7739.
PMID: 21534232
citation: Biffi R, de Braud F, Orsi F, Pozzi S, Mauri S, Goldhirsch A, Nole F, Andreoni B. Totally implantable central venous access ports for long-term chemotherapy. A prospective study analyzing complications and costs of 333 devices with a minimum follow-up of 180 days. Ann Oncol. 1998 Jul;9(7):767-73. doi: 10.1023/a:1008392423469.
PMID: 9739444
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hyo-Cheol Kim
investigator title: Clinical Assistant Professor
mesh term: Anesthetics