<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/NCT03796819</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AFCRC2017SJ-007</org_study_id>
    <nct_id>NCT03796819</nct_id>
  </id_info>
  <brief_title>Routine Lymphadenectomy for Intrahepatic Cholangiocarcinoma</brief_title>
  <acronym>LND for ICC</acronym>
  <official_title>Impact of Routine Lymphadenectomy on Prognosis of Patients Undergoing Curative Resection for Intrahepatic Cholangiocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ningxia Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanchang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Binzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shaanxi Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shaanxi University of Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Third Affiliated Hospital of Beijing University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The role of routine lymphadenectomy (LND) in the surgical treatment of intrahepatic&#xD;
      cholangiocarcinoma (ICC) remains controversial. The investigators' multi-institutional&#xD;
      retrospective study have showed an increasing adoption of LND among patients undergoing&#xD;
      curative resection for ICC during the last decade. The current prospective and randomized&#xD;
      study based on a multi-institutional collaboration would investigate whether routine LND&#xD;
      would benefit patients in short- and long-term survival remains.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver cancer and its&#xD;
      incidence is increasing worldwide.Resection of the primary ICC tumor site within the liver&#xD;
      represents the best curative treatment option. However, the role of lymphadenectomy (LND) at&#xD;
      the time of surgery remains controversial with some centers considering it standard while&#xD;
      other surgeons perform LND only in select circumstances. The utilization of LND may not only&#xD;
      vary among different institutions, but also by geographic region. Specifically, data from&#xD;
      East and West centers have noted a variation in the utilization of LND ranging 27%-100%.While&#xD;
      several case series from Asia have noted that most centers do not regularly perform LND,other&#xD;
      data from the West suggest that LND may be becoming more routine. Despite the lack of&#xD;
      consensus among surgeons, the American Joint Committee on Cancer (AJCC) Staging manual&#xD;
      recommends that the nodal basin be staged. Disease-specific staging for ICC was first&#xD;
      introduced in the 7th edition of the AJCC staging manual published in 2010. The newly updated&#xD;
      8th edition of the AJCC staging system now recommends that 6 lymph nodes be evaluated to&#xD;
      stage a patient with ICC.&#xD;
&#xD;
      The previous multi-institutional retrospective study from the investigators have showed an&#xD;
      increasing adoption of LND among patients undergoing curative resection for ICC during the&#xD;
      last decade. The current prospective and randomized study based on a multi-institutional&#xD;
      collaboration would investigate whether routine LND would benefit patients in short- and&#xD;
      long-term survival remains.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 2021</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>
    <intervention_model_description>routine hepatoduodenal lymphadenectomy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>patients would not be told about the lymphadenectomy</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>1-year recurrence rate</measure>
    <time_frame>1 year after surgery (up to 1 year)</time_frame>
    <description>compare the 1-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3-year recurrence rate</measure>
    <time_frame>3 years after surgery (up to 3 years)</time_frame>
    <description>compare the 3-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative morbidity</measure>
    <time_frame>From the date of surgery to stitches off (up to 1 month)</time_frame>
    <description>investigate the postoperative morbidity, such as hepatic failure, postoperative bleeding, superficial and deep site infection between lymphadenectomy and no lymphadenectomy groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-year overall survival</measure>
    <time_frame>1 year after surgery (up to 1 year)</time_frame>
    <description>compare the 1-year overall survival rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year overall survival</measure>
    <time_frame>3 years after surgery (up to 3 years)</time_frame>
    <description>compare the 3-year overall survival rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Intrahepatic Cholangiocarcinoma</condition>
  <arm_group>
    <arm_group_label>lymphadenectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of patients would undergo routine hepatoduodenal lymphadenectomy combined with ICC resection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No lymphadenectomy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group of patients would not undergo hepatoduodenal lymphadenectomy when preoperative imaging and intraoperative exploration found no lymph node enlargement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>lymphadenectomy</intervention_name>
    <description>Patients would undergo routine hepatoduodenal lymphadenectomy at the time of ICC resection</description>
    <arm_group_label>lymphadenectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with intrahepatic cholangiocarcinoma by imaging or biopsy&#xD;
&#xD;
          -  The tumor is limited in the liver with no distant metastasis, and the primary disease&#xD;
             is resectable&#xD;
&#xD;
          -  Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found&#xD;
             no nodal swelling or enlargement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The primary disease is unresectable with or without distant metastasis&#xD;
&#xD;
          -  The liver function or general condition of patients does not permit surgery&#xD;
&#xD;
          -  Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found&#xD;
             obvious nodal swelling or enlargement, which indicates lymphadenectomy should be&#xD;
             performed&#xD;
&#xD;
          -  Patients aged below 18 or older than 65 would be excluded&#xD;
&#xD;
          -  Pregnant women would not be enrolled&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi Lv, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xu-Feng Zhang, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 6, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>December 7, 2021</last_update_submitted>
  <last_update_submitted_qc>December 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intrahepatic cholangiocarcinoma</keyword>
  <keyword>surgery</keyword>
  <keyword>lymphadenectomy</keyword>
  <keyword>lymph node metastasis</keyword>
  <keyword>prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</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/NCT03796819
org study id: XJTU1AFCRC2017SJ-007
nct id: NCT03796819
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The role of routine lymphadenectomy (LND) in the surgical treatment of intrahepatic
      cholangiocarcinoma (ICC) remains controversial. The investigators' multi-institutional
      retrospective study have showed an increasing adoption of LND among patients undergoing
      curative resection for ICC during the last decade. The current prospective and randomized
      study based on a multi-institutional collaboration would investigate whether routine LND
      would benefit patients in short- and long-term survival remains.
Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver cancer and its
      incidence is increasing worldwide.Resection of the primary ICC tumor site within the liver
      represents the best curative treatment option. However, the role of lymphadenectomy (LND) at
      the time of surgery remains controversial with some centers considering it standard while
      other surgeons perform LND only in select circumstances. The utilization of LND may not only
      vary among different institutions, but also by geographic region. Specifically, data from
      East and West centers have noted a variation in the utilization of LND ranging 27%-100%.While
      several case series from Asia have noted that most centers do not regularly perform LND,other
      data from the West suggest that LND may be becoming more routine. Despite the lack of
      consensus among surgeons, the American Joint Committee on Cancer (AJCC) Staging manual
      recommends that the nodal basin be staged. Disease-specific staging for ICC was first
      introduced in the 7th edition of the AJCC staging manual published in 2010. The newly updated
      8th edition of the AJCC staging system now recommends that 6 lymph nodes be evaluated to
      stage a patient with ICC.

      The previous multi-institutional retrospective study from the investigators have showed an
      increasing adoption of LND among patients undergoing curative resection for ICC during the
      last decade. The current prospective and randomized study based on a multi-institutional
      collaboration would investigate whether routine LND would benefit patients in short- and
      long-term survival remains.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: routine hepatoduodenal lymphadenectomy
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: patients would not be told about the lymphadenectomy
measure: 1-year recurrence rate
time frame: 1 year after surgery (up to 1 year)
description: compare the 1-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy
measure: 3-year recurrence rate
time frame: 3 years after surgery (up to 3 years)
description: compare the 3-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy
measure: Postoperative morbidity
time frame: From the date of surgery to stitches off (up to 1 month)
description: investigate the postoperative morbidity, such as hepatic failure, postoperative bleeding, superficial and deep site infection between lymphadenectomy and no lymphadenectomy groups
measure: 1-year overall survival
time frame: 1 year after surgery (up to 1 year)
description: compare the 1-year overall survival rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy
measure: 3-year overall survival
time frame: 3 years after surgery (up to 3 years)
description: compare the 3-year overall survival rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy
arm group label: lymphadenectomy
arm group type: Experimental
description: This group of patients would undergo routine hepatoduodenal lymphadenectomy combined with ICC resection
arm group label: No lymphadenectomy
arm group type: No Intervention
description: This group of patients would not undergo hepatoduodenal lymphadenectomy when preoperative imaging and intraoperative exploration found no lymph node enlargement.
intervention type: Procedure
intervention name: lymphadenectomy
description: Patients would undergo routine hepatoduodenal lymphadenectomy at the time of ICC resection
arm group label: lymphadenectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yi Lv, MD, PhD
role: Study Chair
affiliation: First Affiliated Hospital Xi'an Jiaotong University
last name: Xu-Feng Zhang, MD,PhD
role: Principal Investigator
affiliation: First Affiliated Hospital Xi'an Jiaotong University
facility: 
country: China
responsible party type: Sponsor
mesh term: Cholangiocarcinoma