<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/NCT03754452</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A1104-51</org_study_id>
    <nct_id>NCT03754452</nct_id>
  </id_info>
  <brief_title>Evaluation of the Sarcopenia in Hepatobiliary Surgery</brief_title>
  <acronym>SARFO</acronym>
  <official_title>Evaluation of the Prevalence, the Diagnosis Tests, and the Associated Morbimortality of Sarcopenia in Hepatobiliary Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</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 sarcopenia is defined as a loss of muscle mass and a loss of muscle function ( strength&#xD;
      or performance). Some studies showed that the sarcopenia increase the postoperative&#xD;
      complications and the overall survival in abdominal surgery. But the sarcopenia is not&#xD;
      evaluated in the Hepatobiliary surgery. This prospective, monconcentrique study aim to&#xD;
      evaluate the prevalence of sarcopenia, and its associated morbimortality in hepatobiliary&#xD;
      surgery for malignant or benign tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 9, 2018</start_date>
  <completion_date type="Anticipated">February 2023</completion_date>
  <primary_completion_date type="Anticipated">February 2023</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>the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking</measure>
    <time_frame>1 month</time_frame>
    <description>for the man : i/impedancemetry BMI&lt;8,87kg/m2 and ii/ a muscular force &lt; 30kg or a walking speed &lt;0,8m/s</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking</measure>
    <time_frame>1 month</time_frame>
    <description>for the woman: i/impedancemetry BMI&lt;6,42kg/m2 and ii/muscular force &lt; 20kg or a walking speed &lt;0,8m/s</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>comparison between the impedancemetry and the abdominopevis CT for the diagnosis of sarcopenia</measure>
    <time_frame>3 months</time_frame>
    <description>impedancemetry used to evaluate the muscular mass&#xD;
abdominopelvis CT evualate the muscular mass by measuring the muscular area on the L3 section</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of the postoperatives complications using the clavien dindo classsification between the patient with sarcopenia and the patient without sarcopenia.</measure>
    <time_frame>4 months</time_frame>
    <description>postoperatives complications evualuated according the clavien dindo classification are : death, nausea, vomit, need of nasogastric tube, liver failure with jaundice, ascites, liver encephalopathy, biliary fistula, biliary peritonitis, hernia, parietal abcess, urinary infection, urinary retention, hematoma, pulmonary embolism, pulmonary infection, pleural effusion, atelectasis, renal failure, hyponatremia, hypernatremia, hypokaliema, hyperkaliema the post operative complication evaluate</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Sarcopenia</condition>
  <condition>Hepatobiliary Disease</condition>
  <condition>Postoperative Complications</condition>
  <condition>Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        - all patients who should have a hepatobiliary surgery for malignant and benign tumor in&#xD;
        the universitary hospital center of Angers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hepatobiliary surgery&#xD;
&#xD;
          -  scheduled surgery&#xD;
&#xD;
          -  oral consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  patient under low protection&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  hepatic encephalopathy stage II, III and IV&#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>Julien BARBIEUX, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Angers</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julien BARBIEUX, Dr</last_name>
    <phone>0241353618</phone>
    <email>Julien.Barbieux@chu-angers.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julien Barbieux, Dr</last_name>
      <email>julien.barbieux@chu-angers.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>July 27, 2022</last_update_submitted>
  <last_update_submitted_qc>July 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Digestive System Diseases</mesh_term>
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Sarcopenia</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03754452
org study id: 2018-A1104-51
nct id: NCT03754452
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The sarcopenia is defined as a loss of muscle mass and a loss of muscle function ( strength
      or performance). Some studies showed that the sarcopenia increase the postoperative
      complications and the overall survival in abdominal surgery. But the sarcopenia is not
      evaluated in the Hepatobiliary surgery. This prospective, monconcentrique study aim to
      evaluate the prevalence of sarcopenia, and its associated morbimortality in hepatobiliary
      surgery for malignant or benign tumors.
observational model: Cohort
time perspective: Prospective
measure: the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking
time frame: 1 month
description: for the man : i/impedancemetry BMI<8,87kg/m2 and ii/ a muscular force < 30kg or a walking speed <0,8m/s
measure: the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking
time frame: 1 month
description: for the woman: i/impedancemetry BMI<6,42kg/m2 and ii/muscular force < 20kg or a walking speed <0,8m/s
measure: comparison between the impedancemetry and the abdominopevis CT for the diagnosis of sarcopenia
time frame: 3 months
description: impedancemetry used to evaluate the muscular mass
abdominopelvis CT evualate the muscular mass by measuring the muscular area on the L3 section
measure: comparison of the postoperatives complications using the clavien dindo classsification between the patient with sarcopenia and the patient without sarcopenia.
time frame: 4 months
description: postoperatives complications evualuated according the clavien dindo classification are : death, nausea, vomit, need of nasogastric tube, liver failure with jaundice, ascites, liver encephalopathy, biliary fistula, biliary peritonitis, hernia, parietal abcess, urinary infection, urinary retention, hematoma, pulmonary embolism, pulmonary infection, pleural effusion, atelectasis, renal failure, hyponatremia, hypernatremia, hypokaliema, hyperkaliema the post operative complication evaluate
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julien BARBIEUX, Dr
role: Principal Investigator
affiliation: University Hospital, Angers
last name: Julien BARBIEUX, Dr
phone: 0241353618
email: Julien.Barbieux@chu-angers.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Digestive System Diseases
mesh term: Liver Diseases
mesh term: Sarcopenia
mesh term: Postoperative Complications
sharing ipd: No