<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/NCT03269786</url>
  </required_header>
  <id_info>
    <org_study_id>laucaevt</org_study_id>
    <nct_id>NCT03269786</nct_id>
  </id_info>
  <brief_title>Changes in Lab and Ultrasonography After Endoscopic Varisceal Treatment</brief_title>
  <official_title>Laoboratory and Ultrasonographic Changes After Endoscopic Varisceal Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      laboratory and ultrasongraphicc changes after endoscopical varices treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2018</start_date>
  <completion_date type="Anticipated">November 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in liver function tests</measure>
    <time_frame>6 months</time_frame>
    <description>Liver function tests (ALT, AST, bilirubin,Albumin,Cbc,Prothrombin time,INR ) level (expected to be lower after endoscopic varisceal treatment&#xD;
(ex</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ultrasonographic changes</measure>
    <time_frame>6 months</time_frame>
    <description>{ portal vein diameter , portal vein velocity and flow direction, volume flow in portal vein , congetive index, spleen size.(expected to be chnged after endoscopic varisceal treatment</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Liver Cirrhosis</condition>
  <arm_group>
    <arm_group_label>cirrhotic patients with esophagel varisces</arm_group_label>
    <description>Endoscopic band ligation or injection scelerotheraby will be done for all patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Liver function tests (ALT,AST,ALBUMIN,BILIRUBIN,INR,PC,CBC)</intervention_name>
    <description>Liver function tests will be assessed after endoscopic varisceal treatment for 6 monthes</description>
    <arm_group_label>cirrhotic patients with esophagel varisces</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>biannual ultrasonography</intervention_name>
    <description>portal vein diameter , portal vein velocity and flow direction, volume flow in portal vein , congetive index, spleen size.will be assessed after endoscopic varisceal treatment by using biannual ultrasonography for 6 monthes</description>
    <arm_group_label>cirrhotic patients with esophagel varisces</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with liver cirrhosis and portal hyprtension with esophagel varisces&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with liver cirrhosis and portal hyprtension with esophagel varisces&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Patients with heart failure or renal failure 2. patients with COPD 3. Patients with&#xD;
             hepato cellular carcinoma and portal vein thrombosis 4. Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>salwa el gendi, professor doctor</last_name>
    <phone>01005766155</phone>
    <email>salwaelgendi@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>hanan sharaf, assistant professor</last_name>
    <phone>01005035006</phone>
    <email>dr_hanansharaf@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assuit</city>
        <zip>171516</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Salwa elgendi, Proessor doctor</last_name>
      <phone>01005766155</phone>
      <email>sawaelgendi@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>hanan sharaf, assI stand professor</last_name>
      <phone>01005035006</phone>
      <email>dr_hanansharaf@.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>October 7, 2018</last_update_submitted>
  <last_update_submitted_qc>October 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mahmoud Abdelhamed</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bilirubin</mesh_term>
  </intervention_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/NCT03269786
org study id: laucaevt
nct id: NCT03269786
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
laboratory and ultrasongraphicc changes after endoscopical varices treatment
observational model: Cohort
time perspective: Cross-Sectional
measure: Changes in liver function tests
time frame: 6 months
description: Liver function tests (ALT, AST, bilirubin,Albumin,Cbc,Prothrombin time,INR ) level (expected to be lower after endoscopic varisceal treatment
(ex
measure: Ultrasonographic changes
time frame: 6 months
description: { portal vein diameter , portal vein velocity and flow direction, volume flow in portal vein , congetive index, spleen size.(expected to be chnged after endoscopic varisceal treatment
arm group label: cirrhotic patients with esophagel varisces
description: Endoscopic band ligation or injection scelerotheraby will be done for all patients
intervention type: Diagnostic Test
intervention name: Liver function tests (ALT,AST,ALBUMIN,BILIRUBIN,INR,PC,CBC)
description: Liver function tests will be assessed after endoscopic varisceal treatment for 6 monthes
arm group label: cirrhotic patients with esophagel varisces
intervention type: Device
intervention name: biannual ultrasonography
description: portal vein diameter , portal vein velocity and flow direction, volume flow in portal vein , congetive index, spleen size.will be assessed after endoscopic varisceal treatment by using biannual ultrasonography for 6 monthes
arm group label: cirrhotic patients with esophagel varisces
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: salwa el gendi, professor doctor
phone: 01005766155
email: salwaelgendi@yahoo.com
last name: hanan sharaf, assistant professor
phone: 01005035006
email: dr_hanansharaf@yahoo.com
facility: 
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mahmoud Abdelhamed
investigator title: principal investigator
mesh term: Liver Cirrhosis
mesh term: Bilirubin
sharing ipd: No