<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/NCT02990351</url>
  </required_header>
  <id_info>
    <org_study_id>HCC and liver transplantation</org_study_id>
    <nct_id>NCT02990351</nct_id>
  </id_info>
  <brief_title>Efficacy of Loco-regional Treatment for Hepatocellular Carcinoma Prior to Living Donor Liver Transplantation in Egypt</brief_title>
  <official_title>Loco-regional Treatment for HCC Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to analyze the outcomes of loco-regional treatment prior Living Donor Liver&#xD;
      Transplantation in patients with HCC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      50 patients received LDLT at Ain Shams Centre for Organ Transplantation (ASCOT) over 1 year&#xD;
      of whom data of 29 HCC patients were analyzed. Twenty patients met the Milan criteria&#xD;
      (68.97%) &amp; 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF&#xD;
      criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down&#xD;
      staging, methods, duration of follow up, the number of the patients who were successfully&#xD;
      down-staged before LT and their outcomes after LT were recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Radiological Response ( complete / partial / tumour progression)in the Radiology (CT/ MRI) before transplantation</measure>
    <time_frame>3 months</time_frame>
    <description>the success of loco-regional therapy for hepatocellular carcinoma in term of radiological complete or partial response in the last spiral triphasic abdominal CT and /or MRI before transpalantation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the degree of accuracy between the last CT/ MRI and the pathology of explant in term of number , size and ablation (complete necrosis ) for HCC</measure>
    <time_frame>3 months</time_frame>
    <description>presence of viable tumour tissue in the explant pathology,&#xD;
mictro vascular invasion&#xD;
capsular or lymph node invasion the degree of accuracy between the last CT/ MRI and the pathology of explant</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">29</enrollment>
  <condition>Hepatocellular Carcinoma (HCC)</condition>
  <condition>Living Donor Liver Transplantation</condition>
  <arm_group>
    <arm_group_label>HCC patients</arm_group_label>
    <description>29 HCC patients who had loco regional therapies for HCC were analyzed. Twenty patients met the Milan criteria (68.97%) &amp; 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down staging, methods, duration of follow up, the number of the patients who were successfully down-staged before LT and their outcomes after LT were recorded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>loco regional therapies for HCC</intervention_name>
    <description>29 HCC patients received locoregonal therapy as a bridging therapy for those who were within milan and as downstaging for those were initially beyond milan. The main LRT types used for our patients were TACE and or RFA and microwave ablation</description>
    <arm_group_label>HCC patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult Egyptian patients prepared for living donor liver transplantation , at Ain Shams&#xD;
        Centre for Organ Transplantation (ASCOT) , Cairo Egypt&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients 18-65 years&#xD;
&#xD;
          2. Patients transplanted for HCC within Milan and UCSF criteria who underwent pre&#xD;
             transplant bridge or down staging treatment for HCC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Tumor progression on the waiting list&#xD;
&#xD;
          2. Vascular invasion by imaging studies&#xD;
&#xD;
          3. Extrahepatic or lymph node metastasis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Iman Fawzy Montasser</investigator_full_name>
    <investigator_title>Associate profesor of tropical medicine , Ain Shams university</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02990351
org study id: HCC and liver transplantation
nct id: NCT02990351
lead sponsor: 
has dmc: No
This study aimed to analyze the outcomes of loco-regional treatment prior Living Donor Liver
      Transplantation in patients with HCC.
50 patients received LDLT at Ain Shams Centre for Organ Transplantation (ASCOT) over 1 year
      of whom data of 29 HCC patients were analyzed. Twenty patients met the Milan criteria
      (68.97%) & 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF
      criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down
      staging, methods, duration of follow up, the number of the patients who were successfully
      down-staged before LT and their outcomes after LT were recorded.
observational model: Cohort
time perspective: Retrospective
measure: Radiological Response ( complete / partial / tumour progression)in the Radiology (CT/ MRI) before transplantation
time frame: 3 months
description: the success of loco-regional therapy for hepatocellular carcinoma in term of radiological complete or partial response in the last spiral triphasic abdominal CT and /or MRI before transpalantation
measure: the degree of accuracy between the last CT/ MRI and the pathology of explant in term of number , size and ablation (complete necrosis ) for HCC
time frame: 3 months
description: presence of viable tumour tissue in the explant pathology,
mictro vascular invasion
capsular or lymph node invasion the degree of accuracy between the last CT/ MRI and the pathology of explant
arm group label: HCC patients
description: 29 HCC patients who had loco regional therapies for HCC were analyzed. Twenty patients met the Milan criteria (68.97%) & 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down staging, methods, duration of follow up, the number of the patients who were successfully down-staged before LT and their outcomes after LT were recorded.
intervention type: Procedure
intervention name: loco regional therapies for HCC
description: 29 HCC patients received locoregonal therapy as a bridging therapy for those who were within milan and as downstaging for those were initially beyond milan. The main LRT types used for our patients were TACE and or RFA and microwave ablation
arm group label: HCC patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Iman Fawzy Montasser
investigator title: Associate profesor of tropical medicine , Ain Shams university
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: Undecided