<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/NCT03007225</url>
  </required_header>
  <id_info>
    <org_study_id>treatment of HCC</org_study_id>
    <nct_id>NCT03007225</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Drug Eluting Beads TACE in Treatment of HCC in Egyptian Patients</brief_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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to to compare the conventional transarterial chemoembolization (cTACE) with&#xD;
      chemoembolization using doxorubicin drug eluting beads (DEB-TACE) for the treatment of&#xD;
      hepatocellular carcinoma regarding short term efficacy and safety in first 3 months after&#xD;
      embolization&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective case control was conducted at the Department of Tropical Medicine and HCC&#xD;
      Clinic, Ain Shams University Hospitals (Cairo, Egypt), The patients were divided according to&#xD;
      the line of treatment into 2 groups:&#xD;
&#xD;
        1. Group (I): Twenty-five patients underwent Chemoembolization with Drug eluting beads.&#xD;
&#xD;
        2. Group (II): Twenty-five patients underwent conventional Chemoembolization (cTACE)&#xD;
&#xD;
      The total number of procedures was 77 sessions (37 sessions of TACE with beads and 40&#xD;
      sessions of conventional TACE).Post-procedure follow up:&#xD;
&#xD;
      Schedule of follow up:&#xD;
&#xD;
      All included patients were checked at:&#xD;
&#xD;
        1. One week after the procedure to detect early post chemoembolization complications and&#xD;
           Patients were subjected to Liver function tests, Kidney function tests, complete blood&#xD;
           count and Abdominal Ultrasound.&#xD;
&#xD;
        2. One and four months after the maneuver.&#xD;
&#xD;
      Patients were subjected to the following in each visit:&#xD;
&#xD;
        1. Complete History taking&#xD;
&#xD;
        2. Thorough clinical examination&#xD;
&#xD;
        3. Laboratory Investigations including:&#xD;
&#xD;
             1. Liver function tests&#xD;
&#xD;
             2. Kidney function tests&#xD;
&#xD;
             3. CBC&#xD;
&#xD;
             4. Serum alpha-fetoprotein.&#xD;
&#xD;
        4. Triphasic pelvi-abdominal CT Follow up imaging was performed at the first and fourth&#xD;
           months after embolization and every 3 months thereafter. Repeated embolization was&#xD;
           scheduled &quot;on demand&quot; basis, if there was residual viable tumor deemed unsuitable for&#xD;
           radiofrequency ablation or surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Complete Response</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment of Radiological response by modified RECIST radiological criteria after treatment (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>HepatoCellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>group 1 Drug eluting beads intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2 Conventional TACE intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trans-arterial chemoembolization (TACE)</intervention_name>
    <description>TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography of the Coeliac and Hepatic arteries to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed.&#xD;
Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performed by cutting gel foam sheets into small pledges mannully then mixed with a contrast material and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved.</description>
    <arm_group_label>group 2 Conventional TACE intervention</arm_group_label>
    <other_name>TACE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TACE with Drug Eluting Beads procedure</intervention_name>
    <description>The same was done as cTACE till the super selective catheterization of the feeding artery.&#xD;
Loading of the beads with Doxorubicin hydrochloride (100-150 mg) was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter (Cobra head catheter; Cordis, USA) or 2.7F microcatheter (Progreat; Terumo, Japan).</description>
    <arm_group_label>group 1 Drug eluting beads intervention</arm_group_label>
    <other_name>DEB-TACE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of HCC according to the European association of study of liver&#xD;
             diseases&#xD;
&#xD;
          -  Early stage HCC (Stage A), using the Barcelona Clinic Liver Cancer (BCLC) staging&#xD;
             system, (single or 3 nodules &lt; 3cm PS 0) whenever curative measures were&#xD;
             contraindicated and BCLC stage B (intermediate HCC).&#xD;
&#xD;
          -  Patent portal vein and its main branches&#xD;
&#xD;
          -  Informed consent from all participants before enrollment in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Child class C according to Child classification (BCLC D).&#xD;
&#xD;
          -  Patients with diffuse HCC (non-measurable lesion).&#xD;
&#xD;
          -  Patients with thrombosis of main portal vein or one of its main branches (BCLC C).&#xD;
&#xD;
          -  Patients with extra hepatic invasion.&#xD;
&#xD;
          -  patients refused to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <results_first_submitted>June 27, 2018</results_first_submitted>
  <results_first_submitted_qc>August 26, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 17, 2020</results_first_posted>
  <last_update_submitted>September 27, 2020</last_update_submitted>
  <last_update_submitted_qc>September 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</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 professor 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, Hepatocellular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorotrianisene</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment finished and study completed Patients collected from HCC clinic full filling the inclusion criteria,Ain Shams University hospitals</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Chemoembolization + Drug Eluting Beads</title>
          <description>Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg)&#xD;
TACE with Drug Eluting Beads procedure: The same was done as cTACE till the super selective catheterization of the feeding artery.&#xD;
Loading of the beads with Doxorubicin hydrochloride (100-150 mg) was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter or 2.7F microcatheter</description>
        </group>
        <group group_id="P2">
          <title>Chemoembolization + Standard TACE Technique</title>
          <description>Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique&#xD;
Trans-arterial chemoembolization (TACE): TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter . Conventional angiography of the Coeliac and Hepatic arteries to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed.&#xD;
Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution.&#xD;
Gel foam embolization was performed then mixed with a contrast material and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25">Followed up for at least 6 months after DEB TACE</participants>
                <participants group_id="P2" count="25">followed up for at least 6 months after TACE</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1</title>
          <description>Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg)&#xD;
The procedure: The same was done as cTACE till the super selective catheterization of the feeding artery.&#xD;
Loading of the beads with Doxorubicin hydrochloride was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter (Cobra head catheter; Cordis, USA) or 2.7F microcatheter (Progreat; Terumo, Japan).</description>
        </group>
        <group group_id="B2">
          <title>Group 2</title>
          <description>Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique&#xD;
TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed.&#xD;
Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performed and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.7" spread="6.8"/>
                    <measurement group_id="B2" value="56" spread="5.5"/>
                    <measurement group_id="B3" value="56.7" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>50 HCC patients entered the study collected from Our weekly HCC clinic,Ain Shams University hodpilals fullfilling the inclusion criteria and after explaining the trial to the patients and obtained informed Vincent from wash patients</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Egypt</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>50 patients with HCC collected from our weekly HCC clinic, Ain Shams University Hospitals</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Complete Response</title>
        <description>Assessment of Radiological response by modified RECIST radiological criteria after treatment (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;)</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg)&#xD;
TACE with Drug Eluting Beads procedure: The same was done as cTACE till the super selective catheterization of the feeding artery.&#xD;
Loading of the beads with Doxorubicin hydrochloride was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique&#xD;
TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed.&#xD;
Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performed and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Complete Response</title>
          <description>Assessment of Radiological response by modified RECIST radiological criteria after treatment (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;)</description>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <desc>Deterioration of liver functions Bleeding from puncture site Sepsis</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1</title>
          <description>Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg)&#xD;
TACE with Drug Eluting Beads procedure: The same was done as cTACE till the super selective catheterization of the feeding artery.&#xD;
Loading of the beads with Doxorubicin hydrochloride was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter</description>
        </group>
        <group group_id="E2">
          <title>Group 2</title>
          <description>Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique&#xD;
:TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed.&#xD;
Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performedand an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Deteriorating liver functions after the manouver</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding from puncture site</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Iman Montasser, Assistant professor of Tropical Medicine member of HCC clinic and group , Ain Sha</name_or_title>
      <organization>Ain Shams University</organization>
      <phone>0020201065065333</phone>
      <email>imanfawzy2@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03007225
org study id: treatment of HCC
nct id: NCT03007225
lead sponsor: 
has dmc: Yes
This study aimed to to compare the conventional transarterial chemoembolization (cTACE) with
      chemoembolization using doxorubicin drug eluting beads (DEB-TACE) for the treatment of
      hepatocellular carcinoma regarding short term efficacy and safety in first 3 months after
      embolization
This prospective case control was conducted at the Department of Tropical Medicine and HCC
      Clinic, Ain Shams University Hospitals (Cairo, Egypt), The patients were divided according to
      the line of treatment into 2 groups:

        1. Group (I): Twenty-five patients underwent Chemoembolization with Drug eluting beads.

        2. Group (II): Twenty-five patients underwent conventional Chemoembolization (cTACE)

      The total number of procedures was 77 sessions (37 sessions of TACE with beads and 40
      sessions of conventional TACE).Post-procedure follow up:

      Schedule of follow up:

      All included patients were checked at:

        1. One week after the procedure to detect early post chemoembolization complications and
           Patients were subjected to Liver function tests, Kidney function tests, complete blood
           count and Abdominal Ultrasound.

        2. One and four months after the maneuver.

      Patients were subjected to the following in each visit:

        1. Complete History taking

        2. Thorough clinical examination

        3. Laboratory Investigations including:

             1. Liver function tests

             2. Kidney function tests

             3. CBC

             4. Serum alpha-fetoprotein.

        4. Triphasic pelvi-abdominal CT Follow up imaging was performed at the first and fourth
           months after embolization and every 3 months thereafter. Repeated embolization was
           scheduled "on demand" basis, if there was residual viable tumor deemed unsuitable for
           radiofrequency ablation or surgery.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Complete Response
time frame: 1 year
description: Assessment of Radiological response by modified RECIST radiological criteria after treatment (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.")
arm group label: group 1 Drug eluting beads intervention
arm group type: Active Comparator
description: Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg)
arm group label: group 2 Conventional TACE intervention
arm group type: Active Comparator
description: Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique
intervention type: Drug
intervention name: Trans-arterial chemoembolization (TACE)
description: TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography of the Coeliac and Hepatic arteries to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed.
Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performed by cutting gel foam sheets into small pledges mannully then mixed with a contrast material and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved.
arm group label: group 2 Conventional TACE intervention
other name: TACE
intervention type: Drug
intervention name: TACE with Drug Eluting Beads procedure
description: The same was done as cTACE till the super selective catheterization of the feeding artery.
Loading of the beads with Doxorubicin hydrochloride (100-150 mg) was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter (Cobra head catheter; Cordis, USA) or 2.7F microcatheter (Progreat; Terumo, Japan).
arm group label: group 1 Drug eluting beads intervention
other name: DEB-TACE
criteria: 
gender: Male
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 professor of tropical medicine , Ain Shams university
mesh term: Carcinoma, Hepatocellular
mesh term: Chlorotrianisene
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 