<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/NCT03293459</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-Cirrhosis-13</org_study_id>
    <nct_id>NCT03293459</nct_id>
  </id_info>
  <brief_title>Influence of Shunt Occlusion on Organ Functions in Hyperammonemic Patients With Cirrhosis Having Porto-systemic Shunt.</brief_title>
  <official_title>Influence of Shunt Occlusion on Organ Functions in Hyperammonemic Patients With Cirrhosis Having Porto-systemic Shunt. A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</source>
  <oversight_info>
    <has_dmc>No</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 spontaneous Porto-systemic shunt is occluded by intervention procedures like Balloon&#xD;
      Occluded Retrograde Transvenous Obliteration (BRTO), Plug-assisted Retrograde Transvenous&#xD;
      Obliteration (PARTO) and shunt occlusion procedures resulting in diversion of blood flow&#xD;
      towards the portal circulation and in turn the liver. According to this investigator&#xD;
      hypothesized that shunt occlusion improves liver volume and function along with beneficial&#xD;
      effect on other organ systems by decreasing ammonia and improving hepatopetal flow. All&#xD;
      patients with cirrhosis having large shunt(&gt;10mm) and raised ammonia levels and will be&#xD;
      randomized to receive standard medical treatment and those receiving shunt occlusion&#xD;
      procedures. Investigator will assess organ functions and liver regenerative potential pre and&#xD;
      post (after 3 to 15 months) procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2017</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increase in liver volume by CT Volumetry.</measure>
    <time_frame>3 to 15 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in MELD (Model for End Stage Liver Disease) in both groups</measure>
    <time_frame>3 to 15 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in T Score</measure>
    <time_frame>3 to 15 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in Plasma ammonia levels in both groups</measure>
    <time_frame>3 to 15 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Shunt Occlusion +SMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Shunt Occlusion +SMT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Medical Treatment (SMT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Shunt Occlusion</intervention_name>
    <description>Catheterization of the Porto-systemic shunt (via the left renal vein for gastro-lienorenal shunt) will be accomplished using a catheter and occlusion will be performed with balloon catheter/vascular plug. Occlusion venography is then performed to define the type of varix/varices and the anatomy of the venous drainage followed by infusion of sclerosant. The occluded balloon were inflated and remained in place for a maximum of 24 hours deflated under fluoroscopy the next day/plug is deployed and sclerosant is injected to obliterate the shunt and follow up CT is done to look for completion on the next day. Follow up CT abdomen is done periodically to look for effect on shunt and organ.</description>
    <arm_group_label>Shunt Occlusion +SMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Standard Medical Treatment (SMT)</intervention_name>
    <description>These will include diet rich in BCAA (branch chain amino acids), laxatives and rifaximin</description>
    <arm_group_label>Shunt Occlusion +SMT</arm_group_label>
    <arm_group_label>Standard Medical Treatment (SMT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent to participate in the study&#xD;
&#xD;
          -  Age 18 to 70 years&#xD;
&#xD;
          -  Cirrhotic patients with large shunts (&gt;10mm) and hyperammonemia (arterial ammonia &gt;1.5&#xD;
             x N)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intractable ascites&#xD;
&#xD;
          -  Hepatocellular Carcinoma&#xD;
&#xD;
          -  Portal Vein Thrombosis or splenic vein thrombosis&#xD;
&#xD;
          -  High risk esophageal varices&#xD;
&#xD;
          -  Pregnant and lactation&#xD;
&#xD;
          -  Significant heart or respiratory failure&#xD;
&#xD;
          -  Active gastrointestinal bleeding&#xD;
&#xD;
          -  Refusal to participate in study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Amar Mukund, MD</last_name>
    <role>Study Director</role>
    <affiliation>Institute of Liver &amp; Biliary Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Liver and Biliary Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>November 13, 2020</last_update_submitted>
  <last_update_submitted_qc>November 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2020</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>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT03293459
org study id: ILBS-Cirrhosis-13
nct id: NCT03293459
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The spontaneous Porto-systemic shunt is occluded by intervention procedures like Balloon
      Occluded Retrograde Transvenous Obliteration (BRTO), Plug-assisted Retrograde Transvenous
      Obliteration (PARTO) and shunt occlusion procedures resulting in diversion of blood flow
      towards the portal circulation and in turn the liver. According to this investigator
      hypothesized that shunt occlusion improves liver volume and function along with beneficial
      effect on other organ systems by decreasing ammonia and improving hepatopetal flow. All
      patients with cirrhosis having large shunt(>10mm) and raised ammonia levels and will be
      randomized to receive standard medical treatment and those receiving shunt occlusion
      procedures. Investigator will assess organ functions and liver regenerative potential pre and
      post (after 3 to 15 months) procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Increase in liver volume by CT Volumetry.
time frame: 3 to 15 months
measure: Reduction in MELD (Model for End Stage Liver Disease) in both groups
time frame: 3 to 15 months
measure: Improvement in T Score
time frame: 3 to 15 months
measure: Reduction in Plasma ammonia levels in both groups
time frame: 3 to 15 months
arm group label: Shunt Occlusion +SMT
arm group type: Experimental
description: Shunt Occlusion +SMT
arm group label: Standard Medical Treatment (SMT)
arm group type: Active Comparator
intervention type: Procedure
intervention name: Shunt Occlusion
description: Catheterization of the Porto-systemic shunt (via the left renal vein for gastro-lienorenal shunt) will be accomplished using a catheter and occlusion will be performed with balloon catheter/vascular plug. Occlusion venography is then performed to define the type of varix/varices and the anatomy of the venous drainage followed by infusion of sclerosant. The occluded balloon were inflated and remained in place for a maximum of 24 hours deflated under fluoroscopy the next day/plug is deployed and sclerosant is injected to obliterate the shunt and follow up CT is done to look for completion on the next day. Follow up CT abdomen is done periodically to look for effect on shunt and organ.
arm group label: Shunt Occlusion +SMT
intervention type: Dietary Supplement
intervention name: Standard Medical Treatment (SMT)
description: These will include diet rich in BCAA (branch chain amino acids), laxatives and rifaximin
arm group label: Shunt Occlusion +SMT
arm group label: Standard Medical Treatment (SMT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Dr Amar Mukund, MD
role: Study Director
affiliation: Institute of Liver & Biliary Sciences
facility: 
country: India
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Fibrosis
sharing ipd: No