xml: <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/NCT06013670</url>
    </required_header>
    <id_info>
      <org_study_id>2022-LCYS-MS-13</org_study_id>
      <nct_id>NCT06013670</nct_id>
    </id_info>
    <brief_title>Standard Therapy and TIPS for Moderate to High-risk Esophageal and Gastric Variceal Bleeding</brief_title>
    <official_title>Endoscopic Therapy+ β Receptor Blockers and TIPS Preventing Rebleeding in Moderate to High-risk Patients With Liver Cirrhosis, Esophageal and Gastric Varices A Multicenter, Prospective Parallel Open Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Nanfang Hospital, Southern Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Beijing Friendship Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</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>
        Comparison of endoscopic therapy combined with non-selective therapy β Receptor blockers&#xD;
        (NSBBs) and TIPS in the treatment of liver cirrhosis&#xD;
  &#xD;
        The impact of reducing bleeding on the survival of critically ill patients. To compare the&#xD;
        effect of endoscopic therapy combined with NSBBs drugs and TIPS on rebleeding and incidence&#xD;
        of Hepatic encephalopathy in patients with moderate risk of liver cirrhosis hemorrhage.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Portal hypertension (PH) is one of the most common and serious adverse consequences of liver&#xD;
        cirrhosis. Its complications, including esophageal and gastric variceal bleeding (EGVB),&#xD;
        intractable ascites, Hepatorenal syndrome, have become the main cause of death in patients&#xD;
        with liver cirrhosis. In patients with compensated cirrhosis, the incidence of varices is 30%&#xD;
        -40%, while in patients with decompensated cirrhosis, the incidence of varices is as high as&#xD;
        85%. Varices progress at a rate of 7% -8% annually, with an annual bleeding rate of 10% -15%&#xD;
        and a 6-week mortality rate of 15% -25% [1,2]. Within 1-2 years after the first bleeding,&#xD;
        approximately 60% of untreated patients experience variceal rebleeding, with a mortality rate&#xD;
        of about 30% [4].&#xD;
  &#xD;
        In recent years, both domestic and international guidelines have recommended the use of&#xD;
        endoscopic ligation in the absence of effective risk stratification measures&#xD;
  &#xD;
        (EVL) Joint Non Selective β Receptor blockers (NSBBs) are the preferred treatment for&#xD;
        preventing rebleeding in patients with esophageal and gastric variceal bleeding due to&#xD;
        cirrhosis (standard treatment), while for those who fail standard treatment (with&#xD;
        rebleeding), transjugular intrahepatic portosystemic shunt (TIPS) is used [4]. Although TIPS&#xD;
        is significantly superior to standard treatment in the prevention of rebleeding, its&#xD;
        complications are relatively more, especially the portal vein blood flow shunt effectively&#xD;
        achieved through TIPS, which leads to Hepatic encephalopathy (HE) caused by insufficient&#xD;
        liver perfusion and liver failure. More importantly, previous studies have not found that&#xD;
        TIPS can improve patient survival. Two RCTs compared TIPS and EVL for secondary prevention of&#xD;
        VB, and concluded that TIPS significantly reduced the occurrence of rebleeding without any&#xD;
        significant difference in 2-year survival rate. [8,9] This may be due to bias caused by the&#xD;
        lack of risk stratification for patients.&#xD;
  &#xD;
        The level of portal vein pressure is closely related to the prognosis of patients. Numerous&#xD;
        studies have shown that hepatic vein pressure gradient (HVPG) can reflect the severity of&#xD;
        portal hypertension, and it is still the &quot;gold standard&quot; for diagnosing portal hypertension.&#xD;
        HVPG has been proven to be the best risk stratification tool for portal hypertension.&#xD;
        Recently, it has also received more and more attention and has been carried out more and more&#xD;
        widely. [3] Although more and more non-invasive methods can be used in daily clinical&#xD;
        practice, non-invasive procedures still cannot replace HVPG in decompensated liver cirrhosis&#xD;
        patients. [3] HVPG ≥ 10 mmHg is defined as clinical dominant portal Hypotension (CSPH), and&#xD;
        variceal bleeding is prone to occur when HVPG ≥ 12 mmHg; In patients with HVPG ≥ 16 mmHg, the&#xD;
        mortality rate of acute variceal bleeding increases; HVPG ≥ 20 mmHg has become an effective&#xD;
        predictor of early rebleeding in clinical practice. [12] Recent expert consensus indicates&#xD;
        that hierarchical treatment of HVPG is a reasonable clinical strategy.&#xD;
  &#xD;
        A domestic study in 2015 concluded that risk stratification based on HVPG contributes to the&#xD;
        decision of secondary prevention and treatment strategies for esophageal and gastric variceal&#xD;
        bleeding in liver cirrhosis. [13] However, the cut-off point of HVPG in risk stratification&#xD;
        has not been clearly demonstrated. Based on the value of HVPG, target patients can be&#xD;
        classified as high-risk (HVPG&gt;20mmHg), medium risk (16mmHg ≤ HVPG ≤ 20mmHg), and low-risk&#xD;
        (HVPG&lt;16mmHg). Previous studies have shown that HVPG&gt;20mmHg is an independent predictor of&#xD;
        rebleeding and frequent death. Therefore, TIPS has been widely recognized as the preferred&#xD;
        method for preventing rebleeding in high-risk patients [16]. However, there is no consensus&#xD;
        on whether to choose TIPS treatment as high-risk patients for moderate to high-risk patients&#xD;
        with 16mmHg ≤ HVPG ≤ 20mmHg. In a small study of 49 patients, the survival probability of&#xD;
        patients with baseline HVPG below 16 mmHg was significantly higher than that of patients with&#xD;
        HVPG above 16 mmHg. [14] In addition, CandidV et al. pointed out that HVPG&gt;16mmHg is one of&#xD;
        the predictive factors for treatment failure in the acute bleeding phase of esophageal and&#xD;
        gastric variceal bleeding. [15] However, there is currently no research indicating that TIPS&#xD;
        can improve the prognosis of patients at moderate risk.&#xD;
  &#xD;
        Our research group has completed three retrospective small sample studies in the early stage.&#xD;
        For patients with HVPG ≥ 20 mmHg, TIPS has a significant reduction in rebleeding rate and&#xD;
        survival benefits compared to standard treatment (propranolol+EVL), consistent with previous&#xD;
        studies. [17] For medium to high-risk patients, TIPS significantly reduced the rate of&#xD;
        rebleeding compared to EVL+NSBBs during a 2-year follow-up period, but did not show&#xD;
        significant benefits in improving survival. [18] In 2021, our research team conducted a&#xD;
        single center retrospective study to compare the clinical efficacy of TIPS and EVL+NSBBs&#xD;
        based on HVPG related risk stratification for secondary prevention of EGVB in cirrhotic&#xD;
        portal hypertension. During a 5-year long-term follow-up, for patients with HVPG ≥ 16mmHg,&#xD;
        patients receiving TIPS can obtain significant survival benefits, and the incidence of&#xD;
        dominant Hepatic encephalopathy is not higher than that of the standard treatment group.&#xD;
  &#xD;
        To further verify the reliability of this conclusion, a multicenter prospective parallel open&#xD;
        clinical study is planned to explore the treatment strategy of secondary prevention for&#xD;
        medium risk patients with 16mmHg ≤ HVPG ≤ 20mmHg. Endoscopic therapy combined with NSBBs drug&#xD;
        therapy and TIPS prevention of rebleeding in medium risk patients with esophageal and gastric&#xD;
        variceal bleeding due to cirrhosis is of great clinical significance.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2026</primary_completion_date>
    <phase>N/A</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rebleeding</measure>
      <time_frame>24 months</time_frame>
      <description>Refer to Baveno VII standard for definition of rebleeding.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hepatic encephalopathy</measure>
      <time_frame>24 months</time_frame>
      <description>The definition and grading of HE refer to the consensus opinion on the diagnosis and treatment of Hepatic encephalopathy in China in 2013. The observation indicators include dominant HE and MHE (OHE). The evaluation of HE is based on the West Haven grading standard. Spontaneous HE is defined as explicit HE that occurs at least once without a clear cause.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">86</enrollment>
    <condition>Portal Hypertension</condition>
    <arm_group>
      <arm_group_label>Endoscopy+NSBBs treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Endoscopic treatment+NSBBs group: After admission, carvedilol 6.25mg qd p.o. was administered to lower portal vein pressure. After one week without any adverse reactions, add the dosage to 12.5mg qd, maintained for a long time, with close monitoring of blood pressure and pulse (morning and evening monitoring) during dosing and later use, to maintain systolic blood pressure&gt;90mmHg and heart rate&gt;55bpm. Otherwise, dosage reduction or even discontinuation of medication is necessary. Endoscopic treatment adopts sequential treatment, with an interval of four weeks, until the varicose vein becomes mild or disappears.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TIPS treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receives TIPS for the prevention of variceal bleeding</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Endoscopy+NSBBs</intervention_name>
      <description>Endoscopic treatment+NSBBs group: After admission, carvedilol 6.25mg qd p.o. was administered to lower portal vein pressure. After one week without any adverse reactions, add the dosage to 12.5mg qd, maintained for a long time, with close monitoring of blood pressure and pulse (morning and evening monitoring) during dosing and later use, to maintain systolic blood pressure&gt;90mmHg and heart rate&gt;55bpm. Otherwise, dosage reduction or even discontinuation of medication is necessary. Endoscopic treatment adopts sequential treatment, with an interval of four weeks, until the varicose vein becomes mild or disappears.</description>
      <arm_group_label>Endoscopy+NSBBs treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Transjugular intrahepatic portosystemic shunt</intervention_name>
      <description>TIPS group: All TIPS procedures are completed by a professional liver disease intervention treatment team.</description>
      <arm_group_label>TIPS treatment group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Confirmed as liver cirrhosis (based on clinical, laboratory examination, imaging, or&#xD;
               liver biopsy), and the disease is caused by viral hepatitis cirrhosis or alcoholic&#xD;
               cirrhosis.&#xD;
  &#xD;
            -  16mmHg ≤ HVPG ≤ 20mmHg&#xD;
  &#xD;
            -  Gastroscopy confirms moderate to severe esophageal and gastric varices (EV and GOV1&#xD;
               types) with at least one history of EGVB&#xD;
  &#xD;
            -  Age 18-80 years old and liver function CTP grading B or C&lt;14 points&#xD;
  &#xD;
            -  Sign the informed consent form;&#xD;
  &#xD;
            -  Expected survival time greater than 1 year&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with cirrhosis associated with non viral hepatitis or Alcoholic hepatitis&#xD;
               Taking NSBBs or other medications to treat portal hypertension within the past 6 weeks&#xD;
  &#xD;
            -  Contraindication for the use of NSBBs, such as bronchial asthma, Cardiogenic shock,&#xD;
               heart block (Ⅱ - Ⅲ degree atrioventricular block), severe or acute heart failure and&#xD;
               sinus bradycardia&#xD;
  &#xD;
            -  Simultaneously taking drugs that affect the metabolism and absorption of NSBBs in the&#xD;
               body&#xD;
  &#xD;
            -  TIPS recanalization treatment due to shunt failure&#xD;
  &#xD;
            -  Serum total bilirubin&gt;85.5 µ mol/L&#xD;
  &#xD;
            -  Preoperative evaluation reveals the presence of liver cancer or extrahepatic tumors,&#xD;
               severe organ dysfunction, and other factors that affect expected survival disease&#xD;
  &#xD;
            -  Intractable ascites or hepatorenal syndrome&#xD;
  &#xD;
            -  Concomitant portal vein cavernous degeneration or severe portal vein system thrombosis&#xD;
  &#xD;
            -  Women who plan to become pregnant or are already pregnant or breastfeeding&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Feng Zhang</last_name>
      <role>Study Chair</role>
      <affiliation>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yuzheng Zhuge</last_name>
      <role>Study Director</role>
      <affiliation>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Feng Zhang</last_name>
      <phone>13951872835</phone>
      <email>fzdndx@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nanjing Drum Tower Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Feng Zhang</last_name>
        <phone>13951872835</phone>
        <email>fzdndx@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013670
  org study id: 2022-LCYS-MS-13
  nct id: NCT06013670
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Comparison of endoscopic therapy combined with non-selective therapy β Receptor blockers
        (NSBBs) and TIPS in the treatment of liver cirrhosis
  
        The impact of reducing bleeding on the survival of critically ill patients. To compare the
        effect of endoscopic therapy combined with NSBBs drugs and TIPS on rebleeding and incidence
        of Hepatic encephalopathy in patients with moderate risk of liver cirrhosis hemorrhage.
  Portal hypertension (PH) is one of the most common and serious adverse consequences of liver
        cirrhosis. Its complications, including esophageal and gastric variceal bleeding (EGVB),
        intractable ascites, Hepatorenal syndrome, have become the main cause of death in patients
        with liver cirrhosis. In patients with compensated cirrhosis, the incidence of varices is 30%
        -40%, while in patients with decompensated cirrhosis, the incidence of varices is as high as
        85%. Varices progress at a rate of 7% -8% annually, with an annual bleeding rate of 10% -15%
        and a 6-week mortality rate of 15% -25% [1,2]. Within 1-2 years after the first bleeding,
        approximately 60% of untreated patients experience variceal rebleeding, with a mortality rate
        of about 30% [4].
  
        In recent years, both domestic and international guidelines have recommended the use of
        endoscopic ligation in the absence of effective risk stratification measures
  
        (EVL) Joint Non Selective β Receptor blockers (NSBBs) are the preferred treatment for
        preventing rebleeding in patients with esophageal and gastric variceal bleeding due to
        cirrhosis (standard treatment), while for those who fail standard treatment (with
        rebleeding), transjugular intrahepatic portosystemic shunt (TIPS) is used [4]. Although TIPS
        is significantly superior to standard treatment in the prevention of rebleeding, its
        complications are relatively more, especially the portal vein blood flow shunt effectively
        achieved through TIPS, which leads to Hepatic encephalopathy (HE) caused by insufficient
        liver perfusion and liver failure. More importantly, previous studies have not found that
        TIPS can improve patient survival. Two RCTs compared TIPS and EVL for secondary prevention of
        VB, and concluded that TIPS significantly reduced the occurrence of rebleeding without any
        significant difference in 2-year survival rate. [8,9] This may be due to bias caused by the
        lack of risk stratification for patients.
  
        The level of portal vein pressure is closely related to the prognosis of patients. Numerous
        studies have shown that hepatic vein pressure gradient (HVPG) can reflect the severity of
        portal hypertension, and it is still the "gold standard" for diagnosing portal hypertension.
        HVPG has been proven to be the best risk stratification tool for portal hypertension.
        Recently, it has also received more and more attention and has been carried out more and more
        widely. [3] Although more and more non-invasive methods can be used in daily clinical
        practice, non-invasive procedures still cannot replace HVPG in decompensated liver cirrhosis
        patients. [3] HVPG ≥ 10 mmHg is defined as clinical dominant portal Hypotension (CSPH), and
        variceal bleeding is prone to occur when HVPG ≥ 12 mmHg; In patients with HVPG ≥ 16 mmHg, the
        mortality rate of acute variceal bleeding increases; HVPG ≥ 20 mmHg has become an effective
        predictor of early rebleeding in clinical practice. [12] Recent expert consensus indicates
        that hierarchical treatment of HVPG is a reasonable clinical strategy.
  
        A domestic study in 2015 concluded that risk stratification based on HVPG contributes to the
        decision of secondary prevention and treatment strategies for esophageal and gastric variceal
        bleeding in liver cirrhosis. [13] However, the cut-off point of HVPG in risk stratification
        has not been clearly demonstrated. Based on the value of HVPG, target patients can be
        classified as high-risk (HVPG>20mmHg), medium risk (16mmHg ≤ HVPG ≤ 20mmHg), and low-risk
        (HVPG<16mmHg). Previous studies have shown that HVPG>20mmHg is an independent predictor of
        rebleeding and frequent death. Therefore, TIPS has been widely recognized as the preferred
        method for preventing rebleeding in high-risk patients [16]. However, there is no consensus
        on whether to choose TIPS treatment as high-risk patients for moderate to high-risk patients
        with 16mmHg ≤ HVPG ≤ 20mmHg. In a small study of 49 patients, the survival probability of
        patients with baseline HVPG below 16 mmHg was significantly higher than that of patients with
        HVPG above 16 mmHg. [14] In addition, CandidV et al. pointed out that HVPG>16mmHg is one of
        the predictive factors for treatment failure in the acute bleeding phase of esophageal and
        gastric variceal bleeding. [15] However, there is currently no research indicating that TIPS
        can improve the prognosis of patients at moderate risk.
  
        Our research group has completed three retrospective small sample studies in the early stage.
        For patients with HVPG ≥ 20 mmHg, TIPS has a significant reduction in rebleeding rate and
        survival benefits compared to standard treatment (propranolol+EVL), consistent with previous
        studies. [17] For medium to high-risk patients, TIPS significantly reduced the rate of
        rebleeding compared to EVL+NSBBs during a 2-year follow-up period, but did not show
        significant benefits in improving survival. [18] In 2021, our research team conducted a
        single center retrospective study to compare the clinical efficacy of TIPS and EVL+NSBBs
        based on HVPG related risk stratification for secondary prevention of EGVB in cirrhotic
        portal hypertension. During a 5-year long-term follow-up, for patients with HVPG ≥ 16mmHg,
        patients receiving TIPS can obtain significant survival benefits, and the incidence of
        dominant Hepatic encephalopathy is not higher than that of the standard treatment group.
  
        To further verify the reliability of this conclusion, a multicenter prospective parallel open
        clinical study is planned to explore the treatment strategy of secondary prevention for
        medium risk patients with 16mmHg ≤ HVPG ≤ 20mmHg. Endoscopic therapy combined with NSBBs drug
        therapy and TIPS prevention of rebleeding in medium risk patients with esophageal and gastric
        variceal bleeding due to cirrhosis is of great clinical significance.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Rebleeding
  time frame: 24 months
  description: Refer to Baveno VII standard for definition of rebleeding.
  measure: Hepatic encephalopathy
  time frame: 24 months
  description: The definition and grading of HE refer to the consensus opinion on the diagnosis and treatment of Hepatic encephalopathy in China in 2013. The observation indicators include dominant HE and MHE (OHE). The evaluation of HE is based on the West Haven grading standard. Spontaneous HE is defined as explicit HE that occurs at least once without a clear cause.
  arm group label: Endoscopy+NSBBs treatment group
  arm group type: Experimental
  description: Endoscopic treatment+NSBBs group: After admission, carvedilol 6.25mg qd p.o. was administered to lower portal vein pressure. After one week without any adverse reactions, add the dosage to 12.5mg qd, maintained for a long time, with close monitoring of blood pressure and pulse (morning and evening monitoring) during dosing and later use, to maintain systolic blood pressure>90mmHg and heart rate>55bpm. Otherwise, dosage reduction or even discontinuation of medication is necessary. Endoscopic treatment adopts sequential treatment, with an interval of four weeks, until the varicose vein becomes mild or disappears.
  arm group label: TIPS treatment group
  arm group type: Experimental
  description: Patients receives TIPS for the prevention of variceal bleeding
  intervention type: Procedure
  intervention name: Endoscopy+NSBBs
  description: Endoscopic treatment+NSBBs group: After admission, carvedilol 6.25mg qd p.o. was administered to lower portal vein pressure. After one week without any adverse reactions, add the dosage to 12.5mg qd, maintained for a long time, with close monitoring of blood pressure and pulse (morning and evening monitoring) during dosing and later use, to maintain systolic blood pressure>90mmHg and heart rate>55bpm. Otherwise, dosage reduction or even discontinuation of medication is necessary. Endoscopic treatment adopts sequential treatment, with an interval of four weeks, until the varicose vein becomes mild or disappears.
  arm group label: Endoscopy+NSBBs treatment group
  intervention type: Procedure
  intervention name: Transjugular intrahepatic portosystemic shunt
  description: TIPS group: All TIPS procedures are completed by a professional liver disease intervention treatment team.
  arm group label: TIPS treatment group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Feng Zhang
  role: Study Chair
  affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  last name: Yuzheng Zhuge
  role: Study Director
  affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  last name: Feng Zhang
  phone: 13951872835
  email: fzdndx@126.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Hypertension, Portal
  sharing ipd: No