<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/NCT02996006</url>
  </required_header>
  <id_info>
    <org_study_id>TJ-liver-200804</org_study_id>
    <nct_id>NCT02996006</nct_id>
  </id_info>
  <brief_title>New Techniques to Reduce Intra-operative Bleeding During Complex Liver Resection</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji Hospital</source>
  <brief_summary>
    <textblock>
      This observational study introduced an new advanced bleeding control strategy during complex&#xD;
      liver resection.This newly described &quot;stepwise vascular control&quot; technique was efficacious&#xD;
      and feasible to control intra-operative bleeding in complex hepatectomy involving second&#xD;
      hepatic hilum and retro-hepatic inferior vena cava.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2009</start_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>blood loss during liver resection</measure>
    <time_frame>duration of operation time</time_frame>
  </primary_outcome>
  <enrollment type="Actual">80</enrollment>
  <condition>Surgical Blood Loss</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>stepwise vascular control</intervention_name>
    <description>Before liver parenchymal resection, we performed &quot;total hepatic vascular preparation for occlusion&quot; with portal triad (PT), infra-hepatic inferior vena cava (IIVC), and supra-hepatic inferior vena cava (SIVC) preparation in order. Then we performed step-by-step vascular occlusion according to the individual bleeding situation.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patient sampling according to the eligibility criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  tumor size is more than 5cm in diameter;&#xD;
&#xD;
          -  these tumor were close to or were compressing main hepatic veins and RIVC directly;&#xD;
&#xD;
          -  Pugh-Child Grade is A or Indocyanine green retention rate at 15min (ICG15%) is less&#xD;
             than 10% .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>41 Years</minimum_age>
    <maximum_age>68 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji Hospital</investigator_affiliation>
    <investigator_full_name>Lei Dou</investigator_full_name>
    <investigator_title>Registrar</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blood Loss, Surgical</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/NCT02996006
org study id: TJ-liver-200804
nct id: NCT02996006
lead sponsor: 
This observational study introduced an new advanced bleeding control strategy during complex
      liver resection.This newly described "stepwise vascular control" technique was efficacious
      and feasible to control intra-operative bleeding in complex hepatectomy involving second
      hepatic hilum and retro-hepatic inferior vena cava.
observational model: Case-Only
time perspective: Cross-Sectional
measure: blood loss during liver resection
time frame: duration of operation time
intervention type: Procedure
intervention name: stepwise vascular control
description: Before liver parenchymal resection, we performed "total hepatic vascular preparation for occlusion" with portal triad (PT), infra-hepatic inferior vena cava (IIVC), and supra-hepatic inferior vena cava (SIVC) preparation in order. Then we performed step-by-step vascular occlusion according to the individual bleeding situation.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 41 Years
maximum age: 68 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Lei Dou
investigator title: Registrar
mesh term: Blood Loss, Surgical