<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/NCT03825848</url>
  </required_header>
  <id_info>
    <org_study_id>B2018-292R</org_study_id>
    <nct_id>NCT03825848</nct_id>
  </id_info>
  <brief_title>The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy</brief_title>
  <official_title>The Influence of Shunting Left/Right Portal Vein Branch on Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy: a Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Through a multicenter randomized controlled trial of TIPS to prevent post-hepatitis B&#xD;
      cirrhosis of esophagogastric varices, the incidence of hepatic encephalopathy, the rate of&#xD;
      stent patency, the incidence of rebleeding and survival in the left and right branches of the&#xD;
      portal vein were compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most common cause of cirrhosis in China is hepatitis B virus infection; post-hepatitis B&#xD;
      cirrhosis with gastroesophageal variceal hemorrhage is common in clinical practice; recent&#xD;
      studies [14] found that implantation of 8 mm diameter is compared with the use of 10 mm&#xD;
      diameter stents. The membrane stent significantly reduced the incidence of HE after TIPS&#xD;
      without affecting the shunt effect. To further evaluate the effect of &quot;left/right branch of&#xD;
      shunt portal&quot; on hepatic encephalopathy after TIPS, we intend to conduct the following&#xD;
      studies: for individual etiology (post-hepatitis B cirrhosis), the only indication (to&#xD;
      prevent recurrent rupture of gastroesophageal varices) ), implanted 8mm diameter Viatorr&#xD;
      stent, unified HE evaluation criteria, and stratified multi-center randomized clinical trial&#xD;
      study with Child classification, hope to guide TIPS in line with China's national conditions&#xD;
      through the high-level evidence-based medical evidence obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 20, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of HE</measure>
    <time_frame>2 years</time_frame>
    <description>compare difference incidence of HE between shunting left and right portal vein branch</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Portal Hypertension</condition>
  <condition>Hepatic Encephalopathy</condition>
  <arm_group>
    <arm_group_label>Left Portal Vein Branch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Shunt left portal vein branch during the trans jugular intrahepatic portal systemic shunt</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Right Portal Vein Branch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Shunt right portal vein branch during the trans jugular intrahepatic portal systemic shunt</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>trans jugular intrahepatic portal systemic shunt</intervention_name>
    <description>Shunting left or right PV branch in the TIPS procedure</description>
    <arm_group_label>Left Portal Vein Branch</arm_group_label>
    <arm_group_label>Right Portal Vein Branch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient's gender is not limited, ≥ 18 years old and ≤ 75 years old;&#xD;
&#xD;
          2. Clinically diagnosed post-hepatitis B cirrhosis;&#xD;
&#xD;
          3. History of esophageal varices venous rupture confirmed by endoscopy, re-bleeding after&#xD;
             standard treatment;&#xD;
&#xD;
          4. Liver function Child A or B;&#xD;
&#xD;
          5. Imaging (CT or MRI) suggests that the left/right first branch of the intrahepatic&#xD;
             portal can construct a shunt;&#xD;
&#xD;
          6. Platelet count ≥ 50 × 109 / L;&#xD;
&#xD;
          7. Prothrombin time (PT) does not exceed the upper limit of the normal control for 3&#xD;
             seconds;&#xD;
&#xD;
          8. Serum creatinine concentration ≤115umol/L;&#xD;
&#xD;
          9. Patients and their families agree to join the clinical trial and sign an informed&#xD;
             consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Imaging confirms portal vein thrombosis;&#xD;
&#xD;
          2. Patients who have undergone previous surgical treatment of portal hypertension&#xD;
             (including splenectomy, surgical disconnection or shunt);&#xD;
&#xD;
          3. Combine any malignant tumor;&#xD;
&#xD;
          4. History of previous hepatic encephalopathy;&#xD;
&#xD;
          5. Consolidation of intractable ascites;&#xD;
&#xD;
          6. Pulmonary artery pressure &gt; 40 mmHg, left ventricular ejection fraction &lt; 50%,&#xD;
             congestive heart failure or severe valvular insufficiency;&#xD;
&#xD;
          7. Others: persistent active bleeding, vital signs can not be maintained, blood ammonia ≥&#xD;
             100, total bilirubin &gt; 51umol / L failed to improve after symptomatic treatment;&#xD;
             combined active infection, especially biliary system inflammation; female patients are&#xD;
             pregnant Or lactation; severe contrast allergy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianjun Luo, doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianjun Luo, Doctor</last_name>
    <phone>+86 13801924777</phone>
    <email>luo.jianjun@zs-hospital.sh.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Interventional Radiology, Zhongshan Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianjun Luo, MD</last_name>
      <email>zhangzihan0217@126.com</email>
    </contact>
    <investigator>
      <last_name>Zhinping Yan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jianjun Luo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Wang Q, Lv Y, Bai M, Wang Z, Liu H, He C, Niu J, Guo W, Luo B, Yin Z, Bai W, Chen H, Wang E, Xia D, Li X, Yuan J, Han N, Cai H, Li T, Xie H, Xia J, Wang J, Zhang H, Wu K, Fan D, Han G. Eight millimetre covered TIPS does not compromise shunt function but reduces hepatic encephalopathy in preventing variceal rebleeding. J Hepatol. 2017 Sep;67(3):508-516. doi: 10.1016/j.jhep.2017.05.006. Epub 2017 May 12.</citation>
    <PMID>28506905</PMID>
  </results_reference>
  <results_reference>
    <citation>American Association for the Study of Liver Diseases; European Association for the Study of the Liver. Hepatic encephalopathy in chronic liver disease: 2014 practice guideline by the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. J Hepatol. 2014 Sep;61(3):642-59. doi: 10.1016/j.jhep.2014.05.042. Epub 2014 Jul 8. No abstract available. Erratum In: J Hepatol. 2015 Oct;63(4):1055.</citation>
    <PMID>25015420</PMID>
  </results_reference>
  <results_reference>
    <citation>Bajaj JS, Heuman DM, Sterling RK, Sanyal AJ, Siddiqui M, Matherly S, Luketic V, Stravitz RT, Fuchs M, Thacker LR, Gilles H, White MB, Unser A, Hovermale J, Gavis E, Noble NA, Wade JB. Validation of EncephalApp, Smartphone-Based Stroop Test, for the Diagnosis of Covert Hepatic Encephalopathy. Clin Gastroenterol Hepatol. 2015 Oct;13(10):1828-1835.e1. doi: 10.1016/j.cgh.2014.05.011. Epub 2014 May 17.</citation>
    <PMID>24846278</PMID>
  </results_reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>August 8, 2019</last_update_submitted>
  <last_update_submitted_qc>August 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2019</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>Hypertension, Portal</mesh_term>
    <mesh_term>Hepatic Encephalopathy</mesh_term>
    <mesh_term>Brain Diseases</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/NCT03825848
org study id: B2018-292R
nct id: NCT03825848
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Through a multicenter randomized controlled trial of TIPS to prevent post-hepatitis B
      cirrhosis of esophagogastric varices, the incidence of hepatic encephalopathy, the rate of
      stent patency, the incidence of rebleeding and survival in the left and right branches of the
      portal vein were compared.
The most common cause of cirrhosis in China is hepatitis B virus infection; post-hepatitis B
      cirrhosis with gastroesophageal variceal hemorrhage is common in clinical practice; recent
      studies [14] found that implantation of 8 mm diameter is compared with the use of 10 mm
      diameter stents. The membrane stent significantly reduced the incidence of HE after TIPS
      without affecting the shunt effect. To further evaluate the effect of "left/right branch of
      shunt portal" on hepatic encephalopathy after TIPS, we intend to conduct the following
      studies: for individual etiology (post-hepatitis B cirrhosis), the only indication (to
      prevent recurrent rupture of gastroesophageal varices) ), implanted 8mm diameter Viatorr
      stent, unified HE evaluation criteria, and stratified multi-center randomized clinical trial
      study with Child classification, hope to guide TIPS in line with China's national conditions
      through the high-level evidence-based medical evidence obtained.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The incidence of HE
time frame: 2 years
description: compare difference incidence of HE between shunting left and right portal vein branch
arm group label: Left Portal Vein Branch
arm group type: Experimental
description: Shunt left portal vein branch during the trans jugular intrahepatic portal systemic shunt
arm group label: Right Portal Vein Branch
arm group type: Experimental
description: Shunt right portal vein branch during the trans jugular intrahepatic portal systemic shunt
intervention type: Procedure
intervention name: trans jugular intrahepatic portal systemic shunt
description: Shunting left or right PV branch in the TIPS procedure
arm group label: Left Portal Vein Branch
arm group label: Right Portal Vein Branch
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jianjun Luo, doctor
role: Study Chair
affiliation: Fudan University
last name: Jianjun Luo, Doctor
phone: +86 13801924777
email: luo.jianjun@zs-hospital.sh.cn
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
citation: Wang Q, Lv Y, Bai M, Wang Z, Liu H, He C, Niu J, Guo W, Luo B, Yin Z, Bai W, Chen H, Wang E, Xia D, Li X, Yuan J, Han N, Cai H, Li T, Xie H, Xia J, Wang J, Zhang H, Wu K, Fan D, Han G. Eight millimetre covered TIPS does not compromise shunt function but reduces hepatic encephalopathy in preventing variceal rebleeding. J Hepatol. 2017 Sep;67(3):508-516. doi: 10.1016/j.jhep.2017.05.006. Epub 2017 May 12.
PMID: 28506905
citation: American Association for the Study of Liver Diseases; European Association for the Study of the Liver. Hepatic encephalopathy in chronic liver disease: 2014 practice guideline by the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. J Hepatol. 2014 Sep;61(3):642-59. doi: 10.1016/j.jhep.2014.05.042. Epub 2014 Jul 8. No abstract available. Erratum In: J Hepatol. 2015 Oct;63(4):1055.
PMID: 25015420
citation: Bajaj JS, Heuman DM, Sterling RK, Sanyal AJ, Siddiqui M, Matherly S, Luketic V, Stravitz RT, Fuchs M, Thacker LR, Gilles H, White MB, Unser A, Hovermale J, Gavis E, Noble NA, Wade JB. Validation of EncephalApp, Smartphone-Based Stroop Test, for the Diagnosis of Covert Hepatic Encephalopathy. Clin Gastroenterol Hepatol. 2015 Oct;13(10):1828-1835.e1. doi: 10.1016/j.cgh.2014.05.011. Epub 2014 May 17.
PMID: 24846278
responsible party type: Sponsor
mesh term: Hypertension, Portal
mesh term: Hepatic Encephalopathy
mesh term: Brain Diseases
sharing ipd: Undecided