<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/NCT01700231</url>
  </required_header>
  <id_info>
    <org_study_id>HVPG/Liver Regeneration Study</org_study_id>
    <nct_id>NCT01700231</nct_id>
  </id_info>
  <brief_title>Plasma and Hemodynamic Markers During Hepatectomy</brief_title>
  <official_title>Monitoring Plasma and Hemodynamic Markers in Patients Undergoing Liver Resection to Identify Pathophysiological Mechanisms and Predict Clinical Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction Liver resection is considered the only curative treatment option for mCRC&#xD;
      patients without extrahepatic disease and is accepted practice. Despite substantial&#xD;
      improvements in surgical techniques, postoperative morbidity and mortality remain an&#xD;
      important concern after major resections. Complications of liver resection, although rare,&#xD;
      include liver failure and acute kidney injury as indicated by oliguria and increased serum&#xD;
      creatinine. The underlying pathophysiological pathways of post-operative renal alteration&#xD;
      following liver resection is an increase in portal venous pressure, based on observations in&#xD;
      animal models or small cohorts. The corpus of data is derived from patients with liver&#xD;
      cirrhosis and subsequent hepatorenal syndrome. These data are limited since cirrhosis cannot&#xD;
      distinguish between metabolic changes, portal hypertension and impaired liver function in the&#xD;
      elucidation of the pathogenesis of renal alterations. Liver resection is therefore a potent&#xD;
      model to evaluate the impact of portal hypertension on the kidney despite stable liver&#xD;
      function.&#xD;
&#xD;
      The most significant factor determining morbidity and mortality following hepatectomy is the&#xD;
      ability of the remnant liver to regenerate. In this context, several growth factors were&#xD;
      shown to regulate the highly orchestrated process of liver regeneration (LR).&#xD;
&#xD;
      Hypothesis The investigators will therefore test the hypothesis that liver resection leads to&#xD;
      a sustained increase of portalvenous pressure with a subsequent episode of oliguric renal&#xD;
      impairment, correlating with the quantity of resected liver.&#xD;
&#xD;
      Furthermore, the investigators will examine the relationship between postoperative liver&#xD;
      regeneration and circulating growth factor levels in patients undergoing hepatectomy. Based&#xD;
      on the preclinical data the investigators hypothesize that a circulating growth factor levels&#xD;
      will be associated with delayed liver regeneration, an increased incidence of postoperative&#xD;
      liver dysfunction and concomitant worse clinical outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Perioperative blood parameters and HVPG</measure>
    <time_frame>90 postoperative days</time_frame>
    <description>Time course and predictive potential of blood parameter and HVPG in patients undergoing liver resection. Clinical outcome parameters are postoperative morbidity, mortality and liver dysfunction</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Hepatorenal Syndrome, Liver Regeneration</condition>
  <arm_group>
    <arm_group_label>Liver resection ,Liver Dysfunction</arm_group_label>
    <description>100 patients will be monitored perioperatively, in a subset of 40 patients hepatic venous pressure gradient will be monitored</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liver resection</intervention_name>
    <description>Liver resection of patient with neoplastic hepatic tumors</description>
    <arm_group_label>Liver resection ,Liver Dysfunction</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      perioperative plasma samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with neoplastic liver tumors undergoing hepatectomy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with neoplastic liver tumors undergoing elective hepatectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non elective hepatic surgery, preoperative HVPG &gt; 10 mmHG, preoperative renal failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edith Fleischmann, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>General Hospital Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>April 6, 2015</last_update_submitted>
  <last_update_submitted_qc>April 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Edith Fleischmann</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>hepatorenal syndrome, liver regeneration, liver dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatorenal Syndrome</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/NCT01700231
org study id: HVPG/Liver Regeneration Study
nct id: NCT01700231
lead sponsor: 
has dmc: No
Introduction Liver resection is considered the only curative treatment option for mCRC
      patients without extrahepatic disease and is accepted practice. Despite substantial
      improvements in surgical techniques, postoperative morbidity and mortality remain an
      important concern after major resections. Complications of liver resection, although rare,
      include liver failure and acute kidney injury as indicated by oliguria and increased serum
      creatinine. The underlying pathophysiological pathways of post-operative renal alteration
      following liver resection is an increase in portal venous pressure, based on observations in
      animal models or small cohorts. The corpus of data is derived from patients with liver
      cirrhosis and subsequent hepatorenal syndrome. These data are limited since cirrhosis cannot
      distinguish between metabolic changes, portal hypertension and impaired liver function in the
      elucidation of the pathogenesis of renal alterations. Liver resection is therefore a potent
      model to evaluate the impact of portal hypertension on the kidney despite stable liver
      function.

      The most significant factor determining morbidity and mortality following hepatectomy is the
      ability of the remnant liver to regenerate. In this context, several growth factors were
      shown to regulate the highly orchestrated process of liver regeneration (LR).

      Hypothesis The investigators will therefore test the hypothesis that liver resection leads to
      a sustained increase of portalvenous pressure with a subsequent episode of oliguric renal
      impairment, correlating with the quantity of resected liver.

      Furthermore, the investigators will examine the relationship between postoperative liver
      regeneration and circulating growth factor levels in patients undergoing hepatectomy. Based
      on the preclinical data the investigators hypothesize that a circulating growth factor levels
      will be associated with delayed liver regeneration, an increased incidence of postoperative
      liver dysfunction and concomitant worse clinical outcome.
observational model: Case-Only
time perspective: Prospective
measure: Perioperative blood parameters and HVPG
time frame: 90 postoperative days
description: Time course and predictive potential of blood parameter and HVPG in patients undergoing liver resection. Clinical outcome parameters are postoperative morbidity, mortality and liver dysfunction
arm group label: Liver resection ,Liver Dysfunction
description: 100 patients will be monitored perioperatively, in a subset of 40 patients hepatic venous pressure gradient will be monitored
intervention type: Procedure
intervention name: Liver resection
description: Liver resection of patient with neoplastic hepatic tumors
arm group label: Liver resection ,Liver Dysfunction
perioperative plasma samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Edith Fleischmann, M.D.
role: Principal Investigator
affiliation: Medical University of Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Edith Fleischmann
investigator title: Clinical Professor
mesh term: Hepatorenal Syndrome