<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/NCT03762876</url>
  </required_header>
  <id_info>
    <org_study_id>S-576/2017</org_study_id>
    <nct_id>NCT03762876</nct_id>
  </id_info>
  <brief_title>Evaluation of Trans-Hepatic Flow Changes in Major Hepatectomy</brief_title>
  <acronym>THEFLOW</acronym>
  <official_title>Evaluation of Trans-Hepatic Flow Changes in Major Hepatectomy-THEFLOW Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Heidelberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Heidelberg</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Changes in trans-hepatic flow after major and extended hepatectomy (EH) can lead to small for&#xD;
      size and flow syndrome (SFSF), which is associated with a significantly higher rate of&#xD;
      morbidity and mortality. The current therapies for SFSF are not effective because tissue&#xD;
      damage following SFSF is usually irreversible and the liver parenchyma loses the ability to&#xD;
      regenerate. Therefore, the best approach to improve patient survival is to predict SFSF and&#xD;
      perform adequate intraoperative preventive procedures.&#xD;
&#xD;
      Portal vein flow (PVF), hepatic artery flow (HAF), and portal vein pressure (PVP) are the&#xD;
      main criteria for development of SFSF after living donor liver transplantation. The&#xD;
      mechanisms that change trans-hepatic flow are similar after hepatectomy and living donor&#xD;
      liver transplantation. Trans-hepatic flow is routinely measured during liver resection, but&#xD;
      the effect of these changes on SFSF has not been studied. Identifying the factors that alter&#xD;
      trans-hepatic flow after hepatectomy would allow hepatic inflow to be modulated before and&#xD;
      after surgery, to prevent SFSF.&#xD;
&#xD;
      Trans-hepatic flow and pressure parameters (PVF, HAF, and PVP) are routinely measured and&#xD;
      monitored during liver resection. The aim of the proposed study is to analyze changes in&#xD;
      these parameters after major hepatectomy and determine the factors that alter trans-hepatic&#xD;
      flow after hepatectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Liver resection is an efficient treatment for primary and secondary hepatic tumors and&#xD;
      increases long term survival. Improvements in patient selection criteria, surgical methods,&#xD;
      and postoperative care have increased the indications for major and extended hepatectomy&#xD;
      (EH). Post-hepatectomy liver failure (PHLF) is a major complication following EH and is&#xD;
      called small for size and flow syndrome (SFSF). SFSF significantly increases morbidity and&#xD;
      mortality. The current SFSF treatments are not effective because tissue damage following SFSF&#xD;
      is irreversible and the liver parenchyma loses the ability to regenerate. The best approach&#xD;
      to improve patient survival is to predict SFSF and perform adequate preventive procedures&#xD;
      during liver resection. SFSF is caused by changes in trans-hepatic flow and a low future&#xD;
      liver remnant volume. Portal vein flow (PVF), hepatic artery flow (HAF), and portal vein&#xD;
      pressure (PVP) are the main criteria for SFSF development. Following EH, the ratio of HAF to&#xD;
      the remnant liver weight (HAF/100gr) decreases, while the PVF/100gr and the PVP increase.&#xD;
      This has various pathologic consequences, which lead to SFSF. Troisi et al. suggested an&#xD;
      upper limit of 250 ml/min/100g for PVF to prevent SFSF after living donor liver&#xD;
      transplantation. A vascular modulation that decreases the PVF/100gr and PVP and increases the&#xD;
      HAF/100gr may prevent SFSF. The mechanisms that alter trans-hepatic flow after hepatectomy&#xD;
      and living donor transplantation are similar, but the effect of these changes on SFSF has not&#xD;
      been studied following liver resection. Exploring the changes in trans-hepatic flow after&#xD;
      major and extended hepatectomy and determining the factors that influence these changes would&#xD;
      allow us to modulate hepatic inflow during hepatectomy to prevent PHLF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 25, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Portal vein flow</measure>
    <time_frame>One day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Portal vein pressure</measure>
    <time_frame>One day</time_frame>
    <description>Vein pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatic artery flow</measure>
    <time_frame>One day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central vein pressure</measure>
    <time_frame>One day</time_frame>
    <description>Vein pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean arterial pressure</measure>
    <time_frame>One day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-hepatectomy liver failure</measure>
    <time_frame>Three months</time_frame>
    <description>Based on the ISGLS criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of morbidity</measure>
    <time_frame>Three months</time_frame>
    <description>Based on the Clavien-Dindo classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of mortality</measure>
    <time_frame>Three months</time_frame>
    <description>All cause death events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grade of liver stiffness</measure>
    <time_frame>Three months</time_frame>
    <description>Via fibroscan before and after resection</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Major Hepatectomy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients underwent Major hepatectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient consent&#xD;
&#xD;
          -  Undergoing major or central liver resection&#xD;
&#xD;
          -  Aged above 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cirrhosis&#xD;
&#xD;
          -  Previous surgery of the hepatoduodenal ligament&#xD;
&#xD;
          -  Status after transjugular intrahepatic portosystemic shunt&#xD;
&#xD;
          -  Metabolic liver diseases&#xD;
&#xD;
          -  Cardiac failure&#xD;
&#xD;
          -  Pulmonary hypertension&#xD;
&#xD;
          -  Portal vein thrombosis&#xD;
&#xD;
          -  Portal vein hypertension&#xD;
&#xD;
          -  Vascular malformation&#xD;
&#xD;
          -  Not able to give consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammad Golriz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of General, Visceral and Transplant Surgery, University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arianeb Mehrabi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Department of General, Visceral and Transplant Surgery, University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohammad Golriz, MD</last_name>
    <phone>004962215638948</phone>
    <email>Mohammad.Golriz@med.uni-heidelberg.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Division of Visceral Transplantation, Department of General, Visceral and Transplantation Surgery, University of Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-Württemberg</state>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arianeb Mehrabi, MD</last_name>
      <phone>0049 - 6221 - 5636223</phone>
      <email>arianeb.mehrabi@med.uni-heidelberg.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>October 11, 2019</last_update_submitted>
  <last_update_submitted_qc>October 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Heidelberg</investigator_affiliation>
    <investigator_full_name>Dr. A. Mehrabi</investigator_full_name>
    <investigator_title>Professsor, Head of the Division of Liver Surgery and Visceral Transplantation</investigator_title>
  </responsible_party>
  <keyword>Hepatectomy</keyword>
  <keyword>Trans-hepatic flow</keyword>
  <keyword>Post-hepatectomy liver failure</keyword>
  <keyword>Mortality</keyword>
  <!-- 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/NCT03762876
org study id: S-576/2017
nct id: NCT03762876
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Changes in trans-hepatic flow after major and extended hepatectomy (EH) can lead to small for
      size and flow syndrome (SFSF), which is associated with a significantly higher rate of
      morbidity and mortality. The current therapies for SFSF are not effective because tissue
      damage following SFSF is usually irreversible and the liver parenchyma loses the ability to
      regenerate. Therefore, the best approach to improve patient survival is to predict SFSF and
      perform adequate intraoperative preventive procedures.

      Portal vein flow (PVF), hepatic artery flow (HAF), and portal vein pressure (PVP) are the
      main criteria for development of SFSF after living donor liver transplantation. The
      mechanisms that change trans-hepatic flow are similar after hepatectomy and living donor
      liver transplantation. Trans-hepatic flow is routinely measured during liver resection, but
      the effect of these changes on SFSF has not been studied. Identifying the factors that alter
      trans-hepatic flow after hepatectomy would allow hepatic inflow to be modulated before and
      after surgery, to prevent SFSF.

      Trans-hepatic flow and pressure parameters (PVF, HAF, and PVP) are routinely measured and
      monitored during liver resection. The aim of the proposed study is to analyze changes in
      these parameters after major hepatectomy and determine the factors that alter trans-hepatic
      flow after hepatectomy.
Liver resection is an efficient treatment for primary and secondary hepatic tumors and
      increases long term survival. Improvements in patient selection criteria, surgical methods,
      and postoperative care have increased the indications for major and extended hepatectomy
      (EH). Post-hepatectomy liver failure (PHLF) is a major complication following EH and is
      called small for size and flow syndrome (SFSF). SFSF significantly increases morbidity and
      mortality. The current SFSF treatments are not effective because tissue damage following SFSF
      is irreversible and the liver parenchyma loses the ability to regenerate. The best approach
      to improve patient survival is to predict SFSF and perform adequate preventive procedures
      during liver resection. SFSF is caused by changes in trans-hepatic flow and a low future
      liver remnant volume. Portal vein flow (PVF), hepatic artery flow (HAF), and portal vein
      pressure (PVP) are the main criteria for SFSF development. Following EH, the ratio of HAF to
      the remnant liver weight (HAF/100gr) decreases, while the PVF/100gr and the PVP increase.
      This has various pathologic consequences, which lead to SFSF. Troisi et al. suggested an
      upper limit of 250 ml/min/100g for PVF to prevent SFSF after living donor liver
      transplantation. A vascular modulation that decreases the PVF/100gr and PVP and increases the
      HAF/100gr may prevent SFSF. The mechanisms that alter trans-hepatic flow after hepatectomy
      and living donor transplantation are similar, but the effect of these changes on SFSF has not
      been studied following liver resection. Exploring the changes in trans-hepatic flow after
      major and extended hepatectomy and determining the factors that influence these changes would
      allow us to modulate hepatic inflow during hepatectomy to prevent PHLF.
observational model: Cohort
time perspective: Prospective
measure: Portal vein flow
time frame: One day
measure: Portal vein pressure
time frame: One day
description: Vein pressure (mmHg)
measure: Hepatic artery flow
time frame: One day
measure: Central vein pressure
time frame: One day
description: Vein pressure (mmHg)
measure: Mean arterial pressure
time frame: One day
measure: Post-hepatectomy liver failure
time frame: Three months
description: Based on the ISGLS criteria
measure: Rate of morbidity
time frame: Three months
description: Based on the Clavien-Dindo classification
measure: Rate of mortality
time frame: Three months
description: All cause death events
measure: Grade of liver stiffness
time frame: Three months
description: Via fibroscan before and after resection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mohammad Golriz, MD
role: Principal Investigator
affiliation: Department of General, Visceral and Transplant Surgery, University Hospital
last name: Arianeb Mehrabi, MD
role: Study Director
affiliation: Department of General, Visceral and Transplant Surgery, University Hospital
last name: Mohammad Golriz, MD
phone: 004962215638948
email: Mohammad.Golriz@med.uni-heidelberg.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Heidelberg
investigator full name: Dr. A. Mehrabi
investigator title: Professsor, Head of the Division of Liver Surgery and Visceral Transplantation