<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/NCT03000855</url>
  </required_header>
  <id_info>
    <org_study_id>CRE-2016.193-T</org_study_id>
    <nct_id>NCT03000855</nct_id>
  </id_info>
  <brief_title>EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures</brief_title>
  <acronym>DRAMBO</acronym>
  <official_title>EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures. A Multi-centred Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tokyo Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kinki University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      EUS - guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage&#xD;
      in unresectable malignant distal CBD strictures when endoscopic retrograde&#xD;
      cholangiopancreatography (ERCP) fails. However, how primary ECDS compares with ERCP with&#xD;
      covered self-expanding metallic stents (CSEMS) in unresectable malignant distal CBD&#xD;
      strictures is uncertain.&#xD;
&#xD;
      The aim of the current study is to compare primary ECDS versus ERCP with CSEMS in&#xD;
      unresectable malignant distal CBD strictures. We hypothesis that ECDS is associated with a&#xD;
      higher 1-year stent patency rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malignant biliary obstruction is a common sequela of pancreatic cancers or distal bile duct&#xD;
      cancers, and its development can hinder the use of chemotherapy, decrease patient quality of&#xD;
      life and decrease survival. Malignant biliary obstruction is traditionally palliated with&#xD;
      ERCP with metallic stent insertion. However, these stents are prone to obstruction due to&#xD;
      tumour ingrowth. In addition, ERCP may not always be possible due to tumour obstruction and&#xD;
      percutaneous biliary drainage may be required.&#xD;
&#xD;
      Recently, ECDS has been described as an alternative to percutaneous biliary drainage in&#xD;
      patients with failed ERCP. The procedure is also associated with potential advantages as&#xD;
      compared to conventional ERCP. In particular, the risk of tumour ingrowth into the stent&#xD;
      placed after ECDS is low and stent patency rates may be better than ERCP. Thus, the aim of&#xD;
      the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant&#xD;
      distal CBD strictures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2022</completion_date>
  <primary_completion_date type="Actual">December 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</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>stent patency rate</measure>
    <time_frame>1-year</time_frame>
    <description>Stent dysfunction is defined as radiology or endoscopy confirmed stent obstruction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical success</measure>
    <time_frame>1year</time_frame>
    <description>Technical success is defined as the ability to access and drain the CBD by placement of a stent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>1 year</time_frame>
    <description>Clinical success is defined as &gt;30% drop in bilirubin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>30 days</time_frame>
    <description>Adverse events related to the endoscopic procedures would be graded according to the lexicon of endoscopic adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">77</enrollment>
  <condition>Malignant Biliary Obstruction</condition>
  <arm_group>
    <arm_group_label>ECDS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EUS-guided choledocho-duodenostomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERCP with CSEMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endoscopic retrograde cholangiopancreatography with covered metallic stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>EUS-guided choledocho-duodenostomy</intervention_name>
    <description>The CBD would be identified by a linear echoendoscope and a suitable puncture site in the bulb of the duodenum would be located. The common bile duct would be punctured with a 19-gauge needle and the position would be confirmed by aspiration of bile and contrast injection. A 0.025&quot; or 0.035&quot; guide wire would be passed through the needle in to the CBD. A fully covered metal stent would then be inserted after track dilation.</description>
    <arm_group_label>ECDS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic retrograde cholangiopancreatography with covered metallic stent</intervention_name>
    <description>After cannulation of the CBD, a cholangiography would be performed to assess the diameter of the CBD, the length and position of the biliary stricture. The endoscopist would decide on the appropriate size of SEMS to be placed. The stents should be visible from the duodenal lumen after deployment.</description>
    <arm_group_label>ERCP with CSEMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old with informed consent&#xD;
&#xD;
          -  Histologically (preferred) or radiologically confirmed distal malignant bile duct&#xD;
             tumors&#xD;
&#xD;
          -  Inoperability by staging, comorbidities or patient wishes&#xD;
&#xD;
          -  Distal tumors 2cm away from the portal hilum&#xD;
&#xD;
          -  Bilirubin &gt; 50umol/L at diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple hepatic metastases with significant blockage of one or more liver segments&#xD;
             (if no segment blockage, metastasis is not an exclusion criteria)&#xD;
&#xD;
          -  Presence of main portal vein thrombosis&#xD;
&#xD;
          -  Prior SEMS placement&#xD;
&#xD;
          -  Intraductal papillary mucinous carcinomas&#xD;
&#xD;
          -  Prior Billroth II or roux-en Y reconstruction&#xD;
&#xD;
          -  History of bleeding disorder or use of anticoagulation&#xD;
&#xD;
          -  Child's B/C cirrhosis&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Performance status ECOG ≥3 (confined to bed / chair &gt; 50% waking hours)&#xD;
&#xD;
          -  Presence of other malignancy&#xD;
&#xD;
          -  Life expectancy &lt; 3months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony Teoh, FRCSEd(Gen</last_name>
    <role>Principal Investigator</role>
    <affiliation>anthoyteoh@surgery.cuhk.edu.hk</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Sydney</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wakayama Medical University School of Medicine</name>
      <address>
        <city>Wakayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>China</country>
    <country>Denmark</country>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Anthony Teoh</investigator_full_name>
    <investigator_title>Honorary Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Malignant biliary obstruction</keyword>
  <keyword>EUS - guided choledocho-duodenostomy</keyword>
  <keyword>ERCP with covered metallic stents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constriction, Pathologic</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/NCT03000855
org study id: CRE-2016.193-T
nct id: NCT03000855
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
EUS - guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage
      in unresectable malignant distal CBD strictures when endoscopic retrograde
      cholangiopancreatography (ERCP) fails. However, how primary ECDS compares with ERCP with
      covered self-expanding metallic stents (CSEMS) in unresectable malignant distal CBD
      strictures is uncertain.

      The aim of the current study is to compare primary ECDS versus ERCP with CSEMS in
      unresectable malignant distal CBD strictures. We hypothesis that ECDS is associated with a
      higher 1-year stent patency rate.
Malignant biliary obstruction is a common sequela of pancreatic cancers or distal bile duct
      cancers, and its development can hinder the use of chemotherapy, decrease patient quality of
      life and decrease survival. Malignant biliary obstruction is traditionally palliated with
      ERCP with metallic stent insertion. However, these stents are prone to obstruction due to
      tumour ingrowth. In addition, ERCP may not always be possible due to tumour obstruction and
      percutaneous biliary drainage may be required.

      Recently, ECDS has been described as an alternative to percutaneous biliary drainage in
      patients with failed ERCP. The procedure is also associated with potential advantages as
      compared to conventional ERCP. In particular, the risk of tumour ingrowth into the stent
      placed after ECDS is low and stent patency rates may be better than ERCP. Thus, the aim of
      the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant
      distal CBD strictures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: stent patency rate
time frame: 1-year
description: Stent dysfunction is defined as radiology or endoscopy confirmed stent obstruction.
measure: Technical success
time frame: 1year
description: Technical success is defined as the ability to access and drain the CBD by placement of a stent.
measure: Clinical success
time frame: 1 year
description: Clinical success is defined as >30% drop in bilirubin levels
measure: Adverse events
time frame: 30 days
description: Adverse events related to the endoscopic procedures would be graded according to the lexicon of endoscopic adverse events
arm group label: ECDS
arm group type: Active Comparator
description: EUS-guided choledocho-duodenostomy
arm group label: ERCP with CSEMS
arm group type: Active Comparator
description: Endoscopic retrograde cholangiopancreatography with covered metallic stent
intervention type: Procedure
intervention name: EUS-guided choledocho-duodenostomy
description: The CBD would be identified by a linear echoendoscope and a suitable puncture site in the bulb of the duodenum would be located. The common bile duct would be punctured with a 19-gauge needle and the position would be confirmed by aspiration of bile and contrast injection. A 0.025" or 0.035" guide wire would be passed through the needle in to the CBD. A fully covered metal stent would then be inserted after track dilation.
arm group label: ECDS
intervention type: Procedure
intervention name: Endoscopic retrograde cholangiopancreatography with covered metallic stent
description: After cannulation of the CBD, a cholangiography would be performed to assess the diameter of the CBD, the length and position of the biliary stricture. The endoscopist would decide on the appropriate size of SEMS to be placed. The stents should be visible from the duodenal lumen after deployment.
arm group label: ERCP with CSEMS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anthony Teoh, FRCSEd(Gen
role: Principal Investigator
affiliation: anthoyteoh@surgery.cuhk.edu.hk
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Belgium
country: China
country: Denmark
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Anthony Teoh
investigator title: Honorary Associate Professor
mesh term: Constriction, Pathologic