<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/NCT03827681</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-Cirrhosis-20</org_study_id>
    <nct_id>NCT03827681</nct_id>
  </id_info>
  <brief_title>To Study the Efficacy and Safety of TIPS (Trans Intrahepatic Portosystemic Shunt) Versus Self Expanding Metallic Stent (SEMS) in the Management of Refractory Variceal Bleed in Cirrhotics.</brief_title>
  <official_title>A Randomised Controlled Trial to Study the Efficacy and Safety of TIPS (Trans Intrahepatic Portosystemic Shunt) Versus Self Expanding Metallic Stent (SEMS) in the Management of Refractory Variceal Bleed in Cirrhotics.</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>
      A total of 50 patients will be enrolled and will be randomized into either Group A(TIPS) or&#xD;
      Group B (SEMS).&#xD;
&#xD;
      Primary end point of the study will be to compare efficacy of TIPS versus SEMS for survival&#xD;
      at 6 week or Early re Bleed. All enrolled patients will also undergo HVPG measurement at&#xD;
      baseline to stratify risk of failure to control bleed or early re-bleed.&#xD;
&#xD;
      Patient will be monitored for 5 days for re bleed, complications of therapy, worsening of&#xD;
      Liver function tests and scores and efficacy of either treatment modality over other. Patient&#xD;
      will be followed for 6 weeks to see for the primary end point.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</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>Survival in both groups</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Re-bleeding in both groups for 5 days from end of therapy</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rebleeding in both groups</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decompensation in both groups in the form of ascites or Hepatic Encephalopathy</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events in both groups</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worsening of liver severity score in both groups.</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Liver Cirrhoses</condition>
  <arm_group>
    <arm_group_label>TIPS + Vasoactive Drug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SEMS + Vasoactive Drug</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trans Intrahepatic Portosystemic Shunt</intervention_name>
    <description>The most common approach is through the right internal jugular approach.&#xD;
After infiltrating the puncture site with 2% lignocaine and puncturing the vein a guide wire is advanced into the IVC followed by a 9F/10F vascular sheath.&#xD;
A wedged venogram is performed with a peripherally placed hepatic vein catheter, which may identify a portion of the portal vein to facilitate subsequent puncture.'&#xD;
A stiff guide wire is then passed through the catheter and the vascular sheath is advanced into the right hepatic vein. With the vascular sheath in place a rigid needle with 15-20 degrees of distal angulation is advanced over the guide wire and through the vascular sheath to enter the hepatic vein.</description>
    <arm_group_label>TIPS + Vasoactive Drug</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Self Expanding Metallic Stent</intervention_name>
    <description>At upper endoscopy, a 0.35 Superstiff radiological guidewire with a soft tip (supplied with the stent insertion kit) is delivered into the stomach under direct vision and the endoscope is removed.&#xD;
The stent delivery device is then advanced over the guidewire into the stomach, and the distal portion of the stent delivery system is withdrawn to allow inflation of the gastric balloon.&#xD;
The gastric balloon is then inflated with 100 mL of air, and the whole delivery system is withdrawn until resistance is felt, which signifies that the balloon is impacting at the cardia, thus anchoring the distal end of the stent during deployment.&#xD;
After stent deployment, the gastric balloon is deflated and the stent delivery system is withdrawn. The stent is then examined endoscopically. When deployed, the stent is 135 mm long and 25 mm wide.</description>
    <arm_group_label>SEMS + Vasoactive Drug</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vasoactive Agent</intervention_name>
    <description>Vasoactive Agent</description>
    <arm_group_label>SEMS + Vasoactive Drug</arm_group_label>
    <arm_group_label>TIPS + Vasoactive Drug</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Consecutive patients of cirrhosis aged 18-70 years presenting with acute variceal&#xD;
        Bleeding, who on endoscopy fail to control bleed or rebleeds within 5 days will be&#xD;
        randomized.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bleeding from non-variceal source&#xD;
&#xD;
          -  Coagulopathy related bleed&#xD;
&#xD;
          -  Bleeding from Gastric varices&#xD;
&#xD;
          -  Any malignancy including HCC&#xD;
&#xD;
          -  Main Portal vein thrombosis&#xD;
&#xD;
          -  Patients in refractory shock&#xD;
&#xD;
          -  Patients with severe cardiopulmonary disease&#xD;
&#xD;
          -  Grade 4 Hepatic encephalopathy&#xD;
&#xD;
          -  MELD &gt; 25&#xD;
&#xD;
          -  Multiorgan failure&#xD;
&#xD;
          -  Active sepsis&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Failure to give consent&#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_contact>
    <last_name>Dr Shushrut Singh, MD</last_name>
    <phone>01146300000</phone>
    <email>drsushrut20@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of Liver &amp; Biliary Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr Shushrut Singh, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 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>
  </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/NCT03827681
org study id: ILBS-Cirrhosis-20
nct id: NCT03827681
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A total of 50 patients will be enrolled and will be randomized into either Group A(TIPS) or
      Group B (SEMS).

      Primary end point of the study will be to compare efficacy of TIPS versus SEMS for survival
      at 6 week or Early re Bleed. All enrolled patients will also undergo HVPG measurement at
      baseline to stratify risk of failure to control bleed or early re-bleed.

      Patient will be monitored for 5 days for re bleed, complications of therapy, worsening of
      Liver function tests and scores and efficacy of either treatment modality over other. Patient
      will be followed for 6 weeks to see for the primary end point.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival in both groups
time frame: 6 weeks
measure: Re-bleeding in both groups for 5 days from end of therapy
time frame: 5 days
measure: Rebleeding in both groups
time frame: 6 weeks
measure: Decompensation in both groups in the form of ascites or Hepatic Encephalopathy
time frame: 6 weeks
measure: Adverse events in both groups
time frame: 6 weeks
measure: Worsening of liver severity score in both groups.
time frame: 6 weeks
arm group label: TIPS + Vasoactive Drug
arm group type: Experimental
arm group label: SEMS + Vasoactive Drug
arm group type: Active Comparator
intervention type: Procedure
intervention name: Trans Intrahepatic Portosystemic Shunt
description: The most common approach is through the right internal jugular approach.
After infiltrating the puncture site with 2% lignocaine and puncturing the vein a guide wire is advanced into the IVC followed by a 9F/10F vascular sheath.
A wedged venogram is performed with a peripherally placed hepatic vein catheter, which may identify a portion of the portal vein to facilitate subsequent puncture.'
A stiff guide wire is then passed through the catheter and the vascular sheath is advanced into the right hepatic vein. With the vascular sheath in place a rigid needle with 15-20 degrees of distal angulation is advanced over the guide wire and through the vascular sheath to enter the hepatic vein.
arm group label: TIPS + Vasoactive Drug
intervention type: Procedure
intervention name: Self Expanding Metallic Stent
description: At upper endoscopy, a 0.35 Superstiff radiological guidewire with a soft tip (supplied with the stent insertion kit) is delivered into the stomach under direct vision and the endoscope is removed.
The stent delivery device is then advanced over the guidewire into the stomach, and the distal portion of the stent delivery system is withdrawn to allow inflation of the gastric balloon.
The gastric balloon is then inflated with 100 mL of air, and the whole delivery system is withdrawn until resistance is felt, which signifies that the balloon is impacting at the cardia, thus anchoring the distal end of the stent during deployment.
After stent deployment, the gastric balloon is deflated and the stent delivery system is withdrawn. The stent is then examined endoscopically. When deployed, the stent is 135 mm long and 25 mm wide.
arm group label: SEMS + Vasoactive Drug
intervention type: Drug
intervention name: Vasoactive Agent
description: Vasoactive Agent
arm group label: SEMS + Vasoactive Drug
arm group label: TIPS + Vasoactive Drug
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Dr Shushrut Singh, MD
phone: 01146300000
email: drsushrut20@gmail.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Sponsor
mesh term: Liver Cirrhosis
sharing ipd: Undecided