<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/NCT02201485</url>
  </required_header>
  <id_info>
    <org_study_id>2BCS-rencanalization</org_study_id>
    <nct_id>NCT02201485</nct_id>
  </id_info>
  <brief_title>Budd-Chiari Syndrome in China: Balloon Angioplasty Alone or Combined With Stent Placement?</brief_title>
  <official_title>Balloon Angioplasty Alone Versus in Combination With Stent Placement for the Treatment of Budd-Chiari Syndrome in China: An Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Air Force Military Medical University, China</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Budd-Chiari syndrome (BCS) is defined as the hepatic outflow obstruction from the small&#xD;
      hepatic veins to the confluence between inferior vena cava and right atrium, which often&#xD;
      leads to the life-threatening complications, such as liver failure and portal&#xD;
      hypertension-related complications. At present, a stepwise treatment strategy is employed,&#xD;
      including anticoagulation, thrombolysis, percutaneous recanalization (i.e., percutaneous&#xD;
      transluminal angioplasty [PTA] alone or in combination with stent placement), transjugular&#xD;
      intrahepatic portosystemic shunt, and liver transplantation. In West, only less than 20% of&#xD;
      BCS patients underwent percutaneous recanalization; by contrast, percutaneous recanalization&#xD;
      is the most common treatment modality used in China.&#xD;
&#xD;
      Recently, an 11-year retrospective case series of 177 Chinese patients with primary BCS has&#xD;
      shown a higher rate of re-occlusion in the PTA alone group than in the PTA combined with&#xD;
      stent placement group (31% versus 7.7%, p&lt;0.001). In addition, re-occlusion was regarded as&#xD;
      the independent predictor of mortality. Accordingly, we hypothesized that PTA alone might&#xD;
      have a worse survival than PTA combined with stent placement in Chinese patients with primary&#xD;
      BCS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">April 2019</completion_date>
  <primary_completion_date type="Actual">September 2017</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 (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of reocclusion between PTA alone and in combination with stent-placement groups</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The survival between PTA alone and in combination with stent placement groups</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of procedure-related complications between PTA alone and in combination with stent placement groups</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The length of hospitalization between PTA alone and in combination with stent placement groups</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The symptom recurrence rate between PTA alone and in combination with stent placement groups</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Budd-Chiari Syndrome</condition>
  <arm_group>
    <arm_group_label>PTA in combination with stent-placement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group, the patients will undergo percutaneous balloon angioplasty with or without stent-placement angioplasty in combination with stent-placement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PTA alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group, the patients will undergo percutaneous balloon angioplasty alone. The patients will transfer to the stent placement in the following cases: 1) reocclusion with thrombosis; and 2) at least 2 reocclusion events.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stent</intervention_name>
    <arm_group_label>PTA in combination with stent-placement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Balloon</intervention_name>
    <arm_group_label>PTA alone</arm_group_label>
    <arm_group_label>PTA in combination with stent-placement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Informed consent.&#xD;
&#xD;
          2. Age 18-75 years old.&#xD;
&#xD;
          3. Budd-Chiari syndrome&#xD;
&#xD;
          4. Child-Pugh score &lt;13 points.&#xD;
&#xD;
          5. Eligible for percutaneous recanalization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or lactation.&#xD;
&#xD;
          2. Malignancy.&#xD;
&#xD;
          3. HIV infection.&#xD;
&#xD;
          4. Severe cardiac or lung diseases.&#xD;
&#xD;
          5. Severe renal dysfunction (serum&gt; 265.2 umol/l).&#xD;
&#xD;
          6. Uncontrolled systemic infection.&#xD;
&#xD;
          7. Allergic to contrast agents.&#xD;
&#xD;
          8. Poor compliance.&#xD;
&#xD;
          9. A prior history of percutaneous recanalization.&#xD;
&#xD;
         10. Ineligible for percutaneous recanalization.&#xD;
&#xD;
         11. Liver cirrhosis with severe portal hypertension-related complications.&#xD;
&#xD;
         12. Acute liver failure.&#xD;
&#xD;
         13. Progressive deterioration of liver function.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guohong Han, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xijing Hospital of Digestive Diseases, Fourth Military Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xijing Hospital of Digestive Diseases</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Han G, Qi X, Zhang W, He C, Yin Z, Wang J, Xia J, Xu K, Guo W, Niu J, Wu K, Fan D. Percutaneous recanalization for Budd-Chiari syndrome: an 11-year retrospective study on patency and survival in 177 Chinese patients from a single center. Radiology. 2013 Feb;266(2):657-67. doi: 10.1148/radiol.12120856. Epub 2012 Nov 9.</citation>
    <PMID>23143028</PMID>
  </reference>
  <reference>
    <citation>Qi X, Han G. Images in clinical medicine. Abdominal-wall varices in the Budd-Chiari syndrome. N Engl J Med. 2014 May 8;370(19):1829. doi: 10.1056/NEJMicm1308567. No abstract available.</citation>
    <PMID>24806162</PMID>
  </reference>
  <reference>
    <citation>Qi X, Wu F, Ren W, He C, Yin Z, Niu J, Bai M, Yang Z, Wu K, Fan D, Han G. Thrombotic risk factors in Chinese Budd-Chiari syndrome patients. An observational study with a systematic review of the literature. Thromb Haemost. 2013 May;109(5):878-84. doi: 10.1160/TH12-10-0784. Epub 2013 Feb 28.</citation>
    <PMID>23447059</PMID>
  </reference>
  <reference>
    <citation>Qi X, Wu F, Fan D, Han G. Prevalence of thrombotic risk factors in Chinese Budd-Chiari syndrome patients: results of a prospective validation study. Eur J Gastroenterol Hepatol. 2014 May;26(5):576-7. doi: 10.1097/MEG.0000000000000056. No abstract available.</citation>
    <PMID>24694738</PMID>
  </reference>
  <reference>
    <citation>Qi X, Guo W, He C, Zhang W, Wu F, Yin Z, Bai M, Niu J, Yang Z, Fan D, Han G. Transjugular intrahepatic portosystemic shunt for Budd-Chiari syndrome: techniques, indications and results on 51 Chinese patients from a single centre. Liver Int. 2014 Sep;34(8):1164-75. doi: 10.1111/liv.12355. Epub 2013 Nov 20.</citation>
    <PMID>24256572</PMID>
  </reference>
  <reference>
    <citation>Qi X, Han G, Guo W, Yin Z, Fan D. Education and Imaging. Hepatobiliary and pancreatic: Budd-Chiari syndrome with infra-hepatic obstruction of inferior vena cava. J Gastroenterol Hepatol. 2013 Jun;28(6):905. doi: 10.1111/jgh.12228. No abstract available.</citation>
    <PMID>23692579</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>April 20, 2019</last_update_submitted>
  <last_update_submitted_qc>April 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
    <investigator_full_name>Guohong Han</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Budd-Chiari syndrome</keyword>
  <keyword>percutaneous recanalization</keyword>
  <keyword>treatment</keyword>
  <keyword>reocclusion</keyword>
  <keyword>patency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Budd-Chiari Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT02201485
org study id: 2BCS-rencanalization
nct id: NCT02201485
lead sponsor: 
has dmc: No
Budd-Chiari syndrome (BCS) is defined as the hepatic outflow obstruction from the small
      hepatic veins to the confluence between inferior vena cava and right atrium, which often
      leads to the life-threatening complications, such as liver failure and portal
      hypertension-related complications. At present, a stepwise treatment strategy is employed,
      including anticoagulation, thrombolysis, percutaneous recanalization (i.e., percutaneous
      transluminal angioplasty [PTA] alone or in combination with stent placement), transjugular
      intrahepatic portosystemic shunt, and liver transplantation. In West, only less than 20% of
      BCS patients underwent percutaneous recanalization; by contrast, percutaneous recanalization
      is the most common treatment modality used in China.

      Recently, an 11-year retrospective case series of 177 Chinese patients with primary BCS has
      shown a higher rate of re-occlusion in the PTA alone group than in the PTA combined with
      stent placement group (31% versus 7.7%, p<0.001). In addition, re-occlusion was regarded as
      the independent predictor of mortality. Accordingly, we hypothesized that PTA alone might
      have a worse survival than PTA combined with stent placement in Chinese patients with primary
      BCS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: The incidence of reocclusion between PTA alone and in combination with stent-placement groups
time frame: 2 years
measure: The survival between PTA alone and in combination with stent placement groups
time frame: 2 years
measure: The incidence of procedure-related complications between PTA alone and in combination with stent placement groups
time frame: 2 years
measure: The length of hospitalization between PTA alone and in combination with stent placement groups
time frame: 2 years
measure: The symptom recurrence rate between PTA alone and in combination with stent placement groups
time frame: 2 years
arm group label: PTA in combination with stent-placement
arm group type: Active Comparator
description: In this group, the patients will undergo percutaneous balloon angioplasty with or without stent-placement angioplasty in combination with stent-placement.
arm group label: PTA alone
arm group type: Active Comparator
description: In this group, the patients will undergo percutaneous balloon angioplasty alone. The patients will transfer to the stent placement in the following cases: 1) reocclusion with thrombosis; and 2) at least 2 reocclusion events.
intervention type: Device
intervention name: Stent
arm group label: PTA in combination with stent-placement
intervention type: Device
intervention name: Balloon
arm group label: PTA alone
arm group label: PTA in combination with stent-placement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Guohong Han, MD
role: Principal Investigator
affiliation: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
facility: 
country: China
citation: Han G, Qi X, Zhang W, He C, Yin Z, Wang J, Xia J, Xu K, Guo W, Niu J, Wu K, Fan D. Percutaneous recanalization for Budd-Chiari syndrome: an 11-year retrospective study on patency and survival in 177 Chinese patients from a single center. Radiology. 2013 Feb;266(2):657-67. doi: 10.1148/radiol.12120856. Epub 2012 Nov 9.
PMID: 23143028
citation: Qi X, Han G. Images in clinical medicine. Abdominal-wall varices in the Budd-Chiari syndrome. N Engl J Med. 2014 May 8;370(19):1829. doi: 10.1056/NEJMicm1308567. No abstract available.
PMID: 24806162
citation: Qi X, Wu F, Ren W, He C, Yin Z, Niu J, Bai M, Yang Z, Wu K, Fan D, Han G. Thrombotic risk factors in Chinese Budd-Chiari syndrome patients. An observational study with a systematic review of the literature. Thromb Haemost. 2013 May;109(5):878-84. doi: 10.1160/TH12-10-0784. Epub 2013 Feb 28.
PMID: 23447059
citation: Qi X, Wu F, Fan D, Han G. Prevalence of thrombotic risk factors in Chinese Budd-Chiari syndrome patients: results of a prospective validation study. Eur J Gastroenterol Hepatol. 2014 May;26(5):576-7. doi: 10.1097/MEG.0000000000000056. No abstract available.
PMID: 24694738
citation: Qi X, Guo W, He C, Zhang W, Wu F, Yin Z, Bai M, Niu J, Yang Z, Fan D, Han G. Transjugular intrahepatic portosystemic shunt for Budd-Chiari syndrome: techniques, indications and results on 51 Chinese patients from a single centre. Liver Int. 2014 Sep;34(8):1164-75. doi: 10.1111/liv.12355. Epub 2013 Nov 20.
PMID: 24256572
citation: Qi X, Han G, Guo W, Yin Z, Fan D. Education and Imaging. Hepatobiliary and pancreatic: Budd-Chiari syndrome with infra-hepatic obstruction of inferior vena cava. J Gastroenterol Hepatol. 2013 Jun;28(6):905. doi: 10.1111/jgh.12228. No abstract available.
PMID: 23692579
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Guohong Han
investigator title: Professor
mesh term: Budd-Chiari Syndrome
mesh term: Syndrome