<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/NCT03783065</url>
  </required_header>
  <id_info>
    <org_study_id>CHESS1803</org_study_id>
    <nct_id>NCT03783065</nct_id>
  </id_info>
  <brief_title>HVPG-guided Laparoscopic Versus Endoscopic Therapy for Variceal Rebleeding in Portal Hypertension: A Multicenter Randomized Controlled Trial (CHESS1803)</brief_title>
  <official_title>HVPG-guided Laparoscopic Versus Endoscopic Therapy for Variceal Rebleeding in Portal Hypertension: A Multicenter Randomized Controlled Trial (CHESS1803)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Southern Medical University, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xingtai People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing 302 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LanZhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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 development of portal hypertension is a vital event in the natural progression of&#xD;
      cirrhosis and is associated with severe complications including gastroesophageal varices&#xD;
      bleeding. Cirrhotic patients with hemorrhagic shock and/or liver failure caused by variceal&#xD;
      bleeding face a mortality of 5-20%.&#xD;
&#xD;
      Hepatic venous pressure gradient (HVPG) is the recommended golden standard for portal&#xD;
      pressure assessment globally with favorable consistency and repeatability. Reducing the HVPG&#xD;
      to levels of 12mmHg or below is associated with protection of variceal hemorrhage. An HVPG&gt;&#xD;
      16mmHg indicates a higher risk of death and HVPG ≥ 20mmHg predicts failure to control&#xD;
      bleeding, early rebleeding, and death during acute variceal hemorrhage.&#xD;
&#xD;
      The management of portal hypertension has showed a trend of diversification with the&#xD;
      development of medication, endoscopy, radiological intervention and liver transplantation.&#xD;
      Although medication and endoscopic therapy have achieved preferable effects and are&#xD;
      recommended as standard of care for the prevention of variceal rebleeding, patients with&#xD;
      HVPG≥ 16mmHg still have a high risk of treatment failure and a high rate of rebleeding.&#xD;
      Recent years, early TIPS is recommended as the first-line therapy for the prevention of&#xD;
      rebleeding in cirrhotic patients with HVPG≥ 20mmHg. However, for those with HVPG values&#xD;
      between 16 to 20mmHg, there is still lack of strong evidence to demonstrate the best practice&#xD;
      for the management.&#xD;
&#xD;
      With the rapid advancement of laparoscopic device and technique, the utility of laparoscopic&#xD;
      splenectomy and pericardial devascularization showed less surgical trauma, bleeding and&#xD;
      complications while retaining dependable effects compared to traditional open surgery,&#xD;
      especially for portal hypertension with hypersplenism. In the study, the investigators aim to&#xD;
      conduct a multicenter randomized controlled trial to compare the safety and effectiveness of&#xD;
      HVPG-guided (16 to 20mmHg) laparoscopic versus endoscopic therapy for variceal rebleeding in&#xD;
      patients with portal hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The development of portal hypertension is a vital event in the natural progression of&#xD;
      cirrhosis and is associated with severe complications including gastroesophageal varices&#xD;
      bleeding. Cirrhotic patients with hemorrhagic shock and/or liver failure caused by variceal&#xD;
      bleeding face a mortality of 5-20%.&#xD;
&#xD;
      Hepatic venous pressure gradient (HVPG) is the recommended golden standard for portal&#xD;
      pressure assessment globally with favorable consistency and repeatability. Reducing the HVPG&#xD;
      to levels of 12mmHg or below is associated with protection of variceal hemorrhage. An HVPG&gt;&#xD;
      16mmHg indicates a higher risk of death and HVPG ≥ 20mmHg predicts failure to control&#xD;
      bleeding, early rebleeding, and death during acute variceal hemorrhage.&#xD;
&#xD;
      The management of portal hypertension has showed a trend of diversification with the&#xD;
      development of medication, endoscopy, radiological intervention and liver transplantation.&#xD;
      Although medication and endoscopic therapy have achieved preferable effects and are&#xD;
      recommended as standard of care for the prevention of variceal rebleeding, patients with&#xD;
      HVPG≥ 16mmHg still have a high risk of treatment failure and a high rate of rebleeding.&#xD;
      Recent years, early TIPS is recommended as the first-line therapy for the prevention of&#xD;
      rebleeding in cirrhotic patients with HVPG≥ 20mmHg. However, for those with HVPG values&#xD;
      between 16 to 20mmHg, there is still lack of strong evidence to demonstrate the best practice&#xD;
      for the management.&#xD;
&#xD;
      With the rapid advancement of laparoscopic device and technique, the utility of laparoscopic&#xD;
      splenectomy and pericardial devascularization showed less surgical trauma, bleeding and&#xD;
      complications while retaining dependable effects compared to traditional open surgery,&#xD;
      especially for portal hypertension with hypersplenism. In the study, the investigators aim to&#xD;
      conduct a multicenter (Shunde Hospital of Southern Medical University, Xingtai People's&#xD;
      Hospital, The Fifth Medical Center of Chinese PLA General Hospital, The First Hospital of&#xD;
      Lanzhou University) randomized controlled trial to compare the safety and effectiveness of&#xD;
      HVPG-guided (16 to 20mmHg) laparoscopic versus endoscopic therapy for variceal rebleeding in&#xD;
      patients with portal hypertension.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Anticipated">October 28, 2022</completion_date>
  <primary_completion_date type="Actual">October 28, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Variceal rebleeding</measure>
    <time_frame>1 year</time_frame>
    <description>The occurrence rate of gastroesophageal varices rebleeding within 1-year follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>1 year</time_frame>
    <description>The number of participants still alive 1 year after the therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatocellular carcinoma occurrence</measure>
    <time_frame>1 year</time_frame>
    <description>The occurrence rate of hepatocellular carcinoma 1 year after the therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Venous thrombosis</measure>
    <time_frame>1 year</time_frame>
    <description>The occurrence rate of venous thrombosis upon each follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life score</measure>
    <time_frame>1 year</time_frame>
    <description>The quality of life score measured using the 36-item Short Form Health Survey (SF-36) questionnaire upon each follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Karnofsky score</measure>
    <time_frame>1 year</time_frame>
    <description>The Karnofsky score categorized into low (score 10-40), intermediate (50-70), and high (80-100) upon each follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Portal Hypertension</condition>
  <condition>Variceal Rebleeding</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Procedure: Laparoscopic splenectomy and pericardial devascularization Drug: Propranolol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Procedure: Endoscopic therapy Drug: Propranolol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propranolol</intervention_name>
    <description>Propranolol was administrated orally while keeping monitoring heart rate and blood pressure daily.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic splenectomy and pericardial devascularization</intervention_name>
    <description>Including splenectomy and pericardial devascularizaion under laparoscopy</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic therapy</intervention_name>
    <description>Either endoscopic variceal ligation (EVL) or cyanoacrylate injection was applied according to the condition of varices</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically and/or pathologically diagnosed cirrhosis with portal hypertension&#xD;
&#xD;
          -  History of varicial bleeding without receiving endoscopic treatment&#xD;
&#xD;
          -  HVPG values between 16-20 mmHg&#xD;
&#xD;
          -  ECOG score ≤ 2 or KPS score ≥ 60 during screening&#xD;
&#xD;
          -  Voluntarily participated in the study and able to provide written informed consent,&#xD;
             understand and willing to comply with the requirements of the study&#xD;
&#xD;
          -  Child-Pugh class A or B&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Prior known or suspected malignancy (hepatocellular carcinoma, cholangiocarcinoma&#xD;
             etc.)&#xD;
&#xD;
          -  Limited coagulation situation (Quick&lt; 50%, PTT&gt; 50 sec, thrombocyte count &lt;50000 / μl&#xD;
             or disturbed thrombocyte function)&#xD;
&#xD;
          -  Massive ascites&#xD;
&#xD;
          -  Child-Pugh class C&#xD;
&#xD;
          -  Refuse or inadequate for HVPG measurement&#xD;
&#xD;
          -  Other situations whose existence judged inadequate for participation by the&#xD;
             investigators&#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>Weidong Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southern Medical University, China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Changzeng Zuo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xingtai People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xun Li, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>LanZhou University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaolong Qi, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Nanfang Hospital, Southern Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaolong Qi, MD</last_name>
    <phone>86-18588602600</phone>
    <email>qixiaolong@vip.163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Fifth Medical Center of Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhiwei Li, MD</last_name>
    </contact>
    <investigator>
      <last_name>Zhiwei Li, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Lanzhou University</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xun Li, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Xun Li, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shunde Hospital, Southern Medical University</name>
      <address>
        <city>Shunde</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Weidong Wang, MD</last_name>
    </contact>
    <investigator>
      <last_name>Weidong Wang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Xingtai People's Hospital</name>
      <address>
        <city>Xingtai</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Changzeng Zuo, MD</last_name>
    </contact>
    <investigator>
      <last_name>Changzeng Zuo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jitao Wang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.</citation>
    <PMID>30215362</PMID>
  </reference>
  <reference>
    <citation>Cremers I, Ribeiro S. Management of variceal and nonvariceal upper gastrointestinal bleeding in patients with cirrhosis. Therap Adv Gastroenterol. 2014 Sep;7(5):206-16. doi: 10.1177/1756283X14538688.</citation>
    <PMID>25177367</PMID>
  </reference>
  <reference>
    <citation>Garcia-Tsao G, Bosch J. Management of varices and variceal hemorrhage in cirrhosis. N Engl J Med. 2010 Mar 4;362(9):823-32. doi: 10.1056/NEJMra0901512. No abstract available. Erratum In: N Engl J Med. 2011 Feb 3;364(5):490. Dosage error in article text.</citation>
    <PMID>20200386</PMID>
  </reference>
  <reference>
    <citation>Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available. Erratum In: Hepatology. 2017 Jul;66(1):304.</citation>
    <PMID>27786365</PMID>
  </reference>
  <reference>
    <citation>de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.</citation>
    <PMID>26047908</PMID>
  </reference>
  <reference>
    <citation>Bosch J, Abraldes JG, Berzigotti A, Garcia-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1.</citation>
    <PMID>19724251</PMID>
  </reference>
  <reference>
    <citation>Saad WE. Endovascular management of gastric varices. Clin Liver Dis. 2014 Nov;18(4):829-51. doi: 10.1016/j.cld.2014.07.005. Epub 2014 Oct 16.</citation>
    <PMID>25438286</PMID>
  </reference>
  <reference>
    <citation>de Souza AR, La Mura V, Reverter E, Seijo S, Berzigotti A, Ashkenazi E, Garcia-Pagan JC, Abraldes JG, Bosch J. Patients whose first episode of bleeding occurs while taking a beta-blocker have high long-term risks of rebleeding and death. Clin Gastroenterol Hepatol. 2012 Jun;10(6):670-6; quiz e58. doi: 10.1016/j.cgh.2012.02.011. Epub 2012 Feb 22. Erratum In: Clin Gastroenterol Hepatol. 2014 Jun;12(6):1056.</citation>
    <PMID>22366180</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanfang Hospital, Southern Medical University</investigator_affiliation>
    <investigator_full_name>Xiaolong Qi</investigator_full_name>
    <investigator_title>Director, Hepatic Hemodynamic Lab</investigator_title>
  </responsible_party>
  <keyword>Variceal Rebleeding</keyword>
  <keyword>Hepatic venous pressure gradient</keyword>
  <keyword>Laparoscopic Therapy</keyword>
  <keyword>Endoscopic Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Portal</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propranolol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD data including age, gender, height, weight, ethnic, past history (including time of bleeding), dignosis, co-morbidity, medication, labortory test results (including blood routine, blood ammonia, clotting time, liver function and renal function), ultrasonic results (including spleen diameter, portal vein diameter, portal vein velocity, splenic vein velocity, etc.), transient elastography results (including liver and spleen stiffness), esophagogastroduodenoscopy results, Child-pugh score, QOL and KPS scores and time of all outcome events will be shared upon publication of this study.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The data will become available upon publication of this study for 2 years.</ipd_time_frame>
    <ipd_access_criteria>Access application is approved by principal investigators.</ipd_access_criteria>
  </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/NCT03783065
org study id: CHESS1803
nct id: NCT03783065
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The development of portal hypertension is a vital event in the natural progression of
      cirrhosis and is associated with severe complications including gastroesophageal varices
      bleeding. Cirrhotic patients with hemorrhagic shock and/or liver failure caused by variceal
      bleeding face a mortality of 5-20%.

      Hepatic venous pressure gradient (HVPG) is the recommended golden standard for portal
      pressure assessment globally with favorable consistency and repeatability. Reducing the HVPG
      to levels of 12mmHg or below is associated with protection of variceal hemorrhage. An HVPG>
      16mmHg indicates a higher risk of death and HVPG ≥ 20mmHg predicts failure to control
      bleeding, early rebleeding, and death during acute variceal hemorrhage.

      The management of portal hypertension has showed a trend of diversification with the
      development of medication, endoscopy, radiological intervention and liver transplantation.
      Although medication and endoscopic therapy have achieved preferable effects and are
      recommended as standard of care for the prevention of variceal rebleeding, patients with
      HVPG≥ 16mmHg still have a high risk of treatment failure and a high rate of rebleeding.
      Recent years, early TIPS is recommended as the first-line therapy for the prevention of
      rebleeding in cirrhotic patients with HVPG≥ 20mmHg. However, for those with HVPG values
      between 16 to 20mmHg, there is still lack of strong evidence to demonstrate the best practice
      for the management.

      With the rapid advancement of laparoscopic device and technique, the utility of laparoscopic
      splenectomy and pericardial devascularization showed less surgical trauma, bleeding and
      complications while retaining dependable effects compared to traditional open surgery,
      especially for portal hypertension with hypersplenism. In the study, the investigators aim to
      conduct a multicenter randomized controlled trial to compare the safety and effectiveness of
      HVPG-guided (16 to 20mmHg) laparoscopic versus endoscopic therapy for variceal rebleeding in
      patients with portal hypertension.
The development of portal hypertension is a vital event in the natural progression of
      cirrhosis and is associated with severe complications including gastroesophageal varices
      bleeding. Cirrhotic patients with hemorrhagic shock and/or liver failure caused by variceal
      bleeding face a mortality of 5-20%.

      Hepatic venous pressure gradient (HVPG) is the recommended golden standard for portal
      pressure assessment globally with favorable consistency and repeatability. Reducing the HVPG
      to levels of 12mmHg or below is associated with protection of variceal hemorrhage. An HVPG>
      16mmHg indicates a higher risk of death and HVPG ≥ 20mmHg predicts failure to control
      bleeding, early rebleeding, and death during acute variceal hemorrhage.

      The management of portal hypertension has showed a trend of diversification with the
      development of medication, endoscopy, radiological intervention and liver transplantation.
      Although medication and endoscopic therapy have achieved preferable effects and are
      recommended as standard of care for the prevention of variceal rebleeding, patients with
      HVPG≥ 16mmHg still have a high risk of treatment failure and a high rate of rebleeding.
      Recent years, early TIPS is recommended as the first-line therapy for the prevention of
      rebleeding in cirrhotic patients with HVPG≥ 20mmHg. However, for those with HVPG values
      between 16 to 20mmHg, there is still lack of strong evidence to demonstrate the best practice
      for the management.

      With the rapid advancement of laparoscopic device and technique, the utility of laparoscopic
      splenectomy and pericardial devascularization showed less surgical trauma, bleeding and
      complications while retaining dependable effects compared to traditional open surgery,
      especially for portal hypertension with hypersplenism. In the study, the investigators aim to
      conduct a multicenter (Shunde Hospital of Southern Medical University, Xingtai People's
      Hospital, The Fifth Medical Center of Chinese PLA General Hospital, The First Hospital of
      Lanzhou University) randomized controlled trial to compare the safety and effectiveness of
      HVPG-guided (16 to 20mmHg) laparoscopic versus endoscopic therapy for variceal rebleeding in
      patients with portal hypertension.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Variceal rebleeding
time frame: 1 year
description: The occurrence rate of gastroesophageal varices rebleeding within 1-year follow-up
measure: Overall survival
time frame: 1 year
description: The number of participants still alive 1 year after the therapy
measure: Hepatocellular carcinoma occurrence
time frame: 1 year
description: The occurrence rate of hepatocellular carcinoma 1 year after the therapy
measure: Venous thrombosis
time frame: 1 year
description: The occurrence rate of venous thrombosis upon each follow-up
measure: Quality of life score
time frame: 1 year
description: The quality of life score measured using the 36-item Short Form Health Survey (SF-36) questionnaire upon each follow-up.
measure: Karnofsky score
time frame: 1 year
description: The Karnofsky score categorized into low (score 10-40), intermediate (50-70), and high (80-100) upon each follow-up.
arm group label: Experimental group
arm group type: Experimental
description: Procedure: Laparoscopic splenectomy and pericardial devascularization Drug: Propranolol
arm group label: Control group
arm group type: Active Comparator
description: Procedure: Endoscopic therapy Drug: Propranolol
intervention type: Drug
intervention name: Propranolol
description: Propranolol was administrated orally while keeping monitoring heart rate and blood pressure daily.
arm group label: Control group
arm group label: Experimental group
intervention type: Procedure
intervention name: Laparoscopic splenectomy and pericardial devascularization
description: Including splenectomy and pericardial devascularizaion under laparoscopy
arm group label: Experimental group
intervention type: Procedure
intervention name: Endoscopic therapy
description: Either endoscopic variceal ligation (EVL) or cyanoacrylate injection was applied according to the condition of varices
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Weidong Wang, MD
role: Principal Investigator
affiliation: Southern Medical University, China
last name: Changzeng Zuo, MD
role: Principal Investigator
affiliation: Xingtai People's Hospital
last name: Xun Li, MD
role: Principal Investigator
affiliation: LanZhou University
last name: Xiaolong Qi, MD
role: Study Chair
affiliation: Nanfang Hospital, Southern Medical University
last name: Xiaolong Qi, MD
phone: 86-18588602600
email: qixiaolong@vip.163.com
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
citation: Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.
PMID: 30215362
citation: Cremers I, Ribeiro S. Management of variceal and nonvariceal upper gastrointestinal bleeding in patients with cirrhosis. Therap Adv Gastroenterol. 2014 Sep;7(5):206-16. doi: 10.1177/1756283X14538688.
PMID: 25177367
citation: Garcia-Tsao G, Bosch J. Management of varices and variceal hemorrhage in cirrhosis. N Engl J Med. 2010 Mar 4;362(9):823-32. doi: 10.1056/NEJMra0901512. No abstract available. Erratum In: N Engl J Med. 2011 Feb 3;364(5):490. Dosage error in article text.
PMID: 20200386
citation: Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available. Erratum In: Hepatology. 2017 Jul;66(1):304.
PMID: 27786365
citation: de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
PMID: 26047908
citation: Bosch J, Abraldes JG, Berzigotti A, Garcia-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1.
PMID: 19724251
citation: Saad WE. Endovascular management of gastric varices. Clin Liver Dis. 2014 Nov;18(4):829-51. doi: 10.1016/j.cld.2014.07.005. Epub 2014 Oct 16.
PMID: 25438286
citation: de Souza AR, La Mura V, Reverter E, Seijo S, Berzigotti A, Ashkenazi E, Garcia-Pagan JC, Abraldes JG, Bosch J. Patients whose first episode of bleeding occurs while taking a beta-blocker have high long-term risks of rebleeding and death. Clin Gastroenterol Hepatol. 2012 Jun;10(6):670-6; quiz e58. doi: 10.1016/j.cgh.2012.02.011. Epub 2012 Feb 22. Erratum In: Clin Gastroenterol Hepatol. 2014 Jun;12(6):1056.
PMID: 22366180
responsible party type: Principal Investigator
investigator affiliation: Nanfang Hospital, Southern Medical University
investigator full name: Xiaolong Qi
investigator title: Director, Hepatic Hemodynamic Lab
mesh term: Hypertension, Portal
mesh term: Hypertension
mesh term: Propranolol
sharing ipd: Yes
ipd description: IPD data including age, gender, height, weight, ethnic, past history (including time of bleeding), dignosis, co-morbidity, medication, labortory test results (including blood routine, blood ammonia, clotting time, liver function and renal function), ultrasonic results (including spleen diameter, portal vein diameter, portal vein velocity, splenic vein velocity, etc.), transient elastography results (including liver and spleen stiffness), esophagogastroduodenoscopy results, Child-pugh score, QOL and KPS scores and time of all outcome events will be shared upon publication of this study.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The data will become available upon publication of this study for 2 years.
ipd access criteria: Access application is approved by principal investigators.