<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/NCT03812250</url>
  </required_header>
  <id_info>
    <org_study_id>2018</org_study_id>
    <nct_id>NCT03812250</nct_id>
  </id_info>
  <brief_title>EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction</brief_title>
  <official_title>EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First People's Hospital of Hangzhou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First People's Hospital of Hangzhou</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>
      Purpose of the study: To compare efficacy, stent patency, re-intervention rate, cost, quality&#xD;
      of life, survival time, and adverse events between EUS-guide biliary drainage (EUS-BD) and&#xD;
      ERCP assisted trans-papillary drainage for malignant biliary obstruction.&#xD;
&#xD;
      Subjects of the study: Patients who have malignant biliary obstruction.&#xD;
&#xD;
      Methods of the study:&#xD;
&#xD;
        -  Prospective randomized controlled study&#xD;
&#xD;
        -  Patients were randomly divided into two groups, EUS-BD group or ERCP group&#xD;
&#xD;
        -  Patients will get assigned procedure (EUS-BD or ERCP assisted trans-papillary&#xD;
           drainage)for decompression of malignant biliary obstruction&#xD;
&#xD;
        -  After the procedure, regular follow up, blood test, and imaging test will be done to&#xD;
           check sufficient biliary decompression, stent patency, re-intervention rate, cost,&#xD;
           quality of life, survival time, and adverse events rate.&#xD;
&#xD;
      Statistical methods: SPSS 23.0 statistical software was used. The measurement data was&#xD;
      expressed as x± s, and t-test or non-parametric test was used. Chi-square test was used for&#xD;
      count data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ERCP is a well-established procedure for the management of malignant biliary obstruction.&#xD;
      However, even in expert hands, ERCP fails in 3%-5% of cases, especially in patients with&#xD;
      surgically altered anatomy or difficult biliary cannulation. In these cases, more invasive&#xD;
      options are usually considered, which including percutaneous trans-hepatic biliary drainage&#xD;
      and surgical intervention, but they all have been associated with a higher risk of&#xD;
      complications and prolonged hospital stay. EUS-guide biliary drainage using a metal stent,&#xD;
      particularly a lumen-apposing metal stent, is a promising technique for biliary decompression&#xD;
      in patients with failed ERCP. There has been growing global experience with EUS-BD in recent&#xD;
      years, and data from expert centers support the feasibility and efficacy of EUS-BD. However,&#xD;
      few researches compared the efficacy and complication rates between EUS-BD and ERCP for&#xD;
      malignant biliary obstruction. The investigators herein aim to conduct a randomized&#xD;
      controlled clinical trial to compare the efficacy and complication rates between EUS-BD and&#xD;
      ERCP for malignant biliary obstruction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">February 15, 2023</completion_date>
  <primary_completion_date type="Actual">February 10, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical success rates</measure>
    <time_frame>one month after the procedures.</time_frame>
    <description>The number of patients with total bilirubin drop more than 50 % compared with baseline after successful endoscopic procedures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events rates</measure>
    <time_frame>within 6-9 months after the procedures</time_frame>
    <description>The number of patients who developed adverse events, included biliary leakage, hemorrhage, perforation, cholangitis as defined and graded according to the consensus guideline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Re-intervention rates</measure>
    <time_frame>within 6-9 months from the procedures</time_frame>
    <description>Number of re-interventions (ERCP or PTCD) that are necessary after successful endoscopic treatment (for example due to stent migration or stent occlusion)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the cost of the procedure and hospitalization.</measure>
    <time_frame>Up to 30 days after the intervention.</time_frame>
    <description>Evaluation of the cost for different procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>within 6-9 months from the procedures</time_frame>
    <description>death in the follow up after endoscopic treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Malignant Biliary Obstruction</condition>
  <arm_group>
    <arm_group_label>ERCP assisted trans-papillary drainage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ERCP assisted trans-papillary drainage for malignant biliary obstruction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EUS-guide biliary drainage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EUS-guide biliary drainage for malignant biliary obstruction</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ERCP assisted trans-papillary drainage for malignant biliary obstruction</intervention_name>
    <description>ERCP assisted trans-papillary drainage for malignant biliary obstruction</description>
    <arm_group_label>ERCP assisted trans-papillary drainage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>EUS-guide biliary drainage for malignant biliary obstruction</intervention_name>
    <description>EUS-guide biliary drainage for malignant biliary obstruction</description>
    <arm_group_label>EUS-guide biliary drainage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age: 18 - 85 years&#xD;
&#xD;
          -  a patients who had malignant biliary obstruction confirmed by imaging examinations and&#xD;
             Pathological examination&#xD;
&#xD;
          -  Hyperbilirubinemia (total bilirubin &gt;= 1.5 mg/dl)&#xD;
&#xD;
          -  inoperable state&#xD;
&#xD;
          -  patients who agree to join this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a patients who cannot endure sedation or therapeutic endoscopic procedure&#xD;
&#xD;
          -  a patients with bleeding tendency (PT &gt; 1.5 INR, PLT &lt; 50,000)&#xD;
&#xD;
          -  patients underwent biliary drainage by surgery, ERCP or percutaneous transhepatic&#xD;
             biliary drainage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaofeng Zhang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>First People's Hospital of Hangzhou</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hangzhou First People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Park JK, Woo YS, Noh DH, Yang JI, Bae SY, Yun HS, Lee JK, Lee KT, Lee KH. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study. Gastrointest Endosc. 2018 Aug;88(2):277-282. doi: 10.1016/j.gie.2018.03.015. Epub 2018 Mar 30.</citation>
    <PMID>29605722</PMID>
  </results_reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>February 18, 2023</last_update_submitted>
  <last_update_submitted_qc>February 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First People's Hospital of Hangzhou</investigator_affiliation>
    <investigator_full_name>Jianfeng Yang</investigator_full_name>
    <investigator_title>Hangzhou First People's Hospital</investigator_title>
  </responsible_party>
  <!-- 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/NCT03812250
org study id: 2018
nct id: NCT03812250
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Purpose of the study: To compare efficacy, stent patency, re-intervention rate, cost, quality
      of life, survival time, and adverse events between EUS-guide biliary drainage (EUS-BD) and
      ERCP assisted trans-papillary drainage for malignant biliary obstruction.

      Subjects of the study: Patients who have malignant biliary obstruction.

      Methods of the study:

        -  Prospective randomized controlled study

        -  Patients were randomly divided into two groups, EUS-BD group or ERCP group

        -  Patients will get assigned procedure (EUS-BD or ERCP assisted trans-papillary
           drainage)for decompression of malignant biliary obstruction

        -  After the procedure, regular follow up, blood test, and imaging test will be done to
           check sufficient biliary decompression, stent patency, re-intervention rate, cost,
           quality of life, survival time, and adverse events rate.

      Statistical methods: SPSS 23.0 statistical software was used. The measurement data was
      expressed as x± s, and t-test or non-parametric test was used. Chi-square test was used for
      count data.
ERCP is a well-established procedure for the management of malignant biliary obstruction.
      However, even in expert hands, ERCP fails in 3%-5% of cases, especially in patients with
      surgically altered anatomy or difficult biliary cannulation. In these cases, more invasive
      options are usually considered, which including percutaneous trans-hepatic biliary drainage
      and surgical intervention, but they all have been associated with a higher risk of
      complications and prolonged hospital stay. EUS-guide biliary drainage using a metal stent,
      particularly a lumen-apposing metal stent, is a promising technique for biliary decompression
      in patients with failed ERCP. There has been growing global experience with EUS-BD in recent
      years, and data from expert centers support the feasibility and efficacy of EUS-BD. However,
      few researches compared the efficacy and complication rates between EUS-BD and ERCP for
      malignant biliary obstruction. The investigators herein aim to conduct a randomized
      controlled clinical trial to compare the efficacy and complication rates between EUS-BD and
      ERCP for malignant biliary obstruction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical success rates
time frame: one month after the procedures.
description: The number of patients with total bilirubin drop more than 50 % compared with baseline after successful endoscopic procedures.
measure: Adverse events rates
time frame: within 6-9 months after the procedures
description: The number of patients who developed adverse events, included biliary leakage, hemorrhage, perforation, cholangitis as defined and graded according to the consensus guideline.
measure: Re-intervention rates
time frame: within 6-9 months from the procedures
description: Number of re-interventions (ERCP or PTCD) that are necessary after successful endoscopic treatment (for example due to stent migration or stent occlusion)
measure: Evaluation of the cost of the procedure and hospitalization.
time frame: Up to 30 days after the intervention.
description: Evaluation of the cost for different procedures.
measure: overall survival
time frame: within 6-9 months from the procedures
description: death in the follow up after endoscopic treatment
arm group label: ERCP assisted trans-papillary drainage
arm group type: Active Comparator
description: ERCP assisted trans-papillary drainage for malignant biliary obstruction
arm group label: EUS-guide biliary drainage
arm group type: Active Comparator
description: EUS-guide biliary drainage for malignant biliary obstruction
intervention type: Procedure
intervention name: ERCP assisted trans-papillary drainage for malignant biliary obstruction
description: ERCP assisted trans-papillary drainage for malignant biliary obstruction
arm group label: ERCP assisted trans-papillary drainage
intervention type: Procedure
intervention name: EUS-guide biliary drainage for malignant biliary obstruction
description: EUS-guide biliary drainage for malignant biliary obstruction
arm group label: EUS-guide biliary drainage
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Xiaofeng Zhang, M.D.
role: Principal Investigator
affiliation: First People's Hospital of Hangzhou
facility: 
country: China
citation: Park JK, Woo YS, Noh DH, Yang JI, Bae SY, Yun HS, Lee JK, Lee KT, Lee KH. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study. Gastrointest Endosc. 2018 Aug;88(2):277-282. doi: 10.1016/j.gie.2018.03.015. Epub 2018 Mar 30.
PMID: 29605722
responsible party type: Principal Investigator
investigator affiliation: First People's Hospital of Hangzhou
investigator full name: Jianfeng Yang
investigator title: Hangzhou First People's Hospital