<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/NCT02238613</url>
  </required_header>
  <id_info>
    <org_study_id>yanliu307</org_study_id>
    <secondary_id>307xhk</secondary_id>
    <nct_id>NCT02238613</nct_id>
  </id_info>
  <brief_title>Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer</brief_title>
  <official_title>Intraluminal Implantation of Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>307 Hospital of PLA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>307 Hospital of PLA</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether radioactive stents and common used plastic&#xD;
      stents are effective and safety in the treatment of unresectable biliary tract cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with unresectable biliary tract cancer (intrahepatic or extrahepatic&#xD;
      cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with&#xD;
      radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional&#xD;
      stent group). After stent placement, the outcomes were compared in terms of tumor response,&#xD;
      progression-free survival, overall survival time, and complications related to the&#xD;
      procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">June 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>Tumor Response rate</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators will conduct CT test or MRI scan after the implantation of the stents in order to measure the tumor size of each patients and evaluate the best tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>6 months</time_frame>
    <description>In order to research the progression-free survival, the investigators will check the presence of progression disease for each patients until the date of disease progression or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>follow-up in interval of stent insertion and death (1 years)</time_frame>
    <description>Overall survival was calculated from the date of randomization until the date of death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>Individual adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Intrahepatic Cholangiocarcinoma</condition>
  <condition>Cholangiocarcinoma of the Extrahepatic Bile Duct</condition>
  <condition>Ampullary Carcinoma</condition>
  <condition>Biliary Obstruction</condition>
  <arm_group>
    <arm_group_label>radioactive stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The radioactive stent carrying seeds iodine 125 is made of Polytetrafluoroethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the irradiation group patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>plastic stent</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The plastic stent is made of polyethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the conventional group patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>radioactive stent</intervention_name>
    <description>radioactive stent carrying seed iodine 125</description>
    <arm_group_label>radioactive stent</arm_group_label>
    <other_name>brand names: carriable radioactive bile duct plastic stent</other_name>
    <other_name>serial numbers and code name: PBS1-A/B-10/160/140</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>plastic stent</intervention_name>
    <description>common plastic stent without carrying seed iodine 125</description>
    <arm_group_label>plastic stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients were eligible if they had received a histopathological or cytologic diagnosis&#xD;
             of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or&#xD;
             extrahepatic cholangiocarcinoma,or ampullary carcinoma)&#xD;
&#xD;
          -  Patients aged between 18 and 80 years&#xD;
&#xD;
          -  an estimated life expectancy of more than 3 months&#xD;
&#xD;
          -  Disease had to be measurable by computed tomography scan (as assessed by Response&#xD;
             Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria&#xD;
&#xD;
          -  TNM stage III-IV&#xD;
&#xD;
          -  no evidence of cancer of another organ.&#xD;
&#xD;
          -  no prior chemotherapy for advanced disease was allowed, but adjuvant/neoadjuvant&#xD;
             therapy was allowed&#xD;
&#xD;
          -  Karnofsky index of ≥60%&#xD;
&#xD;
          -  ECOG index ≥2&#xD;
&#xD;
          -  previous technically successful stenting or ENBD derange&#xD;
&#xD;
          -  Accept of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant cardiovascular disease&#xD;
&#xD;
          -  coagulation disorders&#xD;
&#xD;
          -  contraindication of Endoscopic&#xD;
&#xD;
          -  pregnant or breastfeeding women&#xD;
&#xD;
          -  known sensitivity sensitivity to investigated agents or components&#xD;
&#xD;
          -  recent invasive procedure&#xD;
&#xD;
          -  prior chemotherapy or radiotherapy for biliary cancer&#xD;
&#xD;
          -  refusal of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yan Liu, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>307 hospital of PLA, Beijing, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yan Liu, MD,PhD</last_name>
    <phone>86-13911798288</phone>
    <email>13911798288@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>307 hospital of PLA</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>10086</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhaoshen Li, Doctor</last_name>
    </contact>
    <investigator>
      <last_name>Min Min, M.D. PhD.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>307 Hospital of PLA</investigator_affiliation>
    <investigator_full_name>yan liu</investigator_full_name>
    <investigator_title>PhD, MD. Chairman of Department of Gastroenterology and Hepatology, 307 Hospital of PLA</investigator_title>
  </responsible_party>
  <keyword>Radioactive stents</keyword>
  <keyword>Brachytherapy</keyword>
  <keyword>Biliary obstruction</keyword>
  <keyword>Intrahepatic Cholangiocarcinoma</keyword>
  <keyword>Cholangiocarcinoma of the Extrahepatic Bile Duct</keyword>
  <keyword>ampullary carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <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/NCT02238613
org study id: yanliu307
secondary id: 307xhk
nct id: NCT02238613
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether radioactive stents and common used plastic
      stents are effective and safety in the treatment of unresectable biliary tract cancer.
Patients with unresectable biliary tract cancer (intrahepatic or extrahepatic
      cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with
      radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional
      stent group). After stent placement, the outcomes were compared in terms of tumor response,
      progression-free survival, overall survival time, and complications related to the
      procedures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tumor Response rate
time frame: 3 months
description: The investigators will conduct CT test or MRI scan after the implantation of the stents in order to measure the tumor size of each patients and evaluate the best tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).
measure: Progression-free survival
time frame: 6 months
description: In order to research the progression-free survival, the investigators will check the presence of progression disease for each patients until the date of disease progression or death.
measure: overall survival
time frame: follow-up in interval of stent insertion and death (1 years)
description: Overall survival was calculated from the date of randomization until the date of death.
measure: Adverse events
time frame: 1 year
description: Individual adverse events
arm group label: radioactive stent
arm group type: Experimental
description: The radioactive stent carrying seeds iodine 125 is made of Polytetrafluoroethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the irradiation group patients.
arm group label: plastic stent
arm group type: Other
description: The plastic stent is made of polyethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the conventional group patients.
intervention type: Device
intervention name: radioactive stent
description: radioactive stent carrying seed iodine 125
arm group label: radioactive stent
other name: brand names: carriable radioactive bile duct plastic stent
other name: serial numbers and code name: PBS1-A/B-10/160/140
intervention type: Device
intervention name: plastic stent
description: common plastic stent without carrying seed iodine 125
arm group label: plastic stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yan Liu, Doctor
role: Principal Investigator
affiliation: 307 hospital of PLA, Beijing, China
last name: Yan Liu, MD,PhD
phone: 86-13911798288
email: 13911798288@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: 307 Hospital of PLA
investigator full name: yan liu
investigator title: PhD, MD. Chairman of Department of Gastroenterology and Hepatology, 307 Hospital of PLA
mesh term: Cholangiocarcinoma
mesh term: Biliary Tract Neoplasms