<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/NCT03821025</url>
  </required_header>
  <id_info>
    <org_study_id>661/2017</org_study_id>
    <nct_id>NCT03821025</nct_id>
  </id_info>
  <brief_title>Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction</brief_title>
  <official_title>Treatment of Malignant Distal Biliary Obstruction - a Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cape Town</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cape Town</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomised clinical trial to compare the clinical efficacy of multiple plastic stents to&#xD;
      fully covered self expanding metal stents in the palliation of distal malignant biliary&#xD;
      obstruction in patients with irresectable tumours.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Number of patients without stent failure</measure>
    <time_frame>12 months</time_frame>
    <description>Number of patients without Stent failure (jaundice) or death with a patent stent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>12 months</time_frame>
    <description>Number of patietns alive in each group at 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent deployment failure</measure>
    <time_frame>During procedure</time_frame>
    <description>Number of patients in whom there was failure to deploy the assigned stent(s) after randomisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost</measure>
    <time_frame>12 months</time_frame>
    <description>The differance in treatment costs between the two groups, measured in USD</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Bile Duct Obstruction, Extrahepatic</condition>
  <condition>Cancer of the Pancreas</condition>
  <condition>Cancer of the Bile Duct</condition>
  <condition>Biliary Stricture</condition>
  <arm_group>
    <arm_group_label>Multiple Plastic Stents</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive two 8.5Fr Platic biliary stents placed side by side across the biliary stricture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-expandable Metal Stents</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive a fully covered Self-expandable Metal Stents (10mm) across the biliary stricture</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biliary stent</intervention_name>
    <description>Palliation of malignant biliary obstruction</description>
    <arm_group_label>Multiple Plastic Stents</arm_group_label>
    <arm_group_label>Self-expandable Metal Stents</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18years of age or older&#xD;
&#xD;
          -  informed consent obtained after oral and written information&#xD;
&#xD;
          -  clinical data in accordance with a malignant bile duct obstruction&#xD;
&#xD;
          -  imaging evidence: (ultrasonography (US), computed tomography (CT) or magnetic&#xD;
             resonance imaging (MRI) shows signs of extrahepatic malignant common bile duct&#xD;
             obstruction&#xD;
&#xD;
          -  typical ERCP findings of a malignant common bile duct stenosis&#xD;
&#xD;
          -  proximal margin of the bile duct stenosis ≥2 cm from the hepatic confluence&#xD;
&#xD;
          -  bilirubin &gt; 50 micromol/L&#xD;
&#xD;
          -  radical surgery not deemed possible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with active hepatitis or other jaundice-causing hepatic diseases&#xD;
&#xD;
          -  informed consent not obtained or patient unable to give informed consent&#xD;
&#xD;
          -  patients with no understanding of English, Afrikaans or Xhosa where it is not possible&#xD;
             to obtain informed consent&#xD;
&#xD;
          -  metastasis with multiple significant intrahepatic stenosis causing blockage of one or&#xD;
             more segments of the liver (liver metastasis otherwise not an exclusion criteria)&#xD;
&#xD;
          -  the patient is a possible candidate for surgical resection&#xD;
&#xD;
          -  suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis&#xD;
             (should initiate further investigations)&#xD;
&#xD;
          -  the proximal end of the stenosis is &lt; 2 cm from the hepatic confluence&#xD;
&#xD;
          -  previous BII or Roux-en-Y gastric reconstruction&#xD;
&#xD;
          -  significant duodenal obstruction making ERCP difficult&#xD;
&#xD;
          -  previous bile duct stent&#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_contact>
    <last_name>Marc M Bernon, MBBCh</last_name>
    <phone>+27 (0)21 404 3042</phone>
    <email>mm.bernon@uct.ac.za</email>
  </overall_contact>
  <location>
    <facility>
      <name>Groote Schuur Hospital</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7925</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc M Bernon, MBBCh</last_name>
      <phone>+27 (0)21 404 3042</phone>
      <email>mm.bernon@uct.ac.za</email>
    </contact>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 26, 2019</study_first_submitted>
  <study_first_submitted_qc>January 26, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>February 18, 2019</last_update_submitted>
  <last_update_submitted_qc>February 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cape Town</investigator_affiliation>
    <investigator_full_name>Marc Bernon</investigator_full_name>
    <investigator_title>Senior consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Bile Duct Neoplasms</mesh_term>
    <mesh_term>Cholestasis</mesh_term>
    <mesh_term>Cholestasis, Extrahepatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03821025
org study id: 661/2017
nct id: NCT03821025
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
A randomised clinical trial to compare the clinical efficacy of multiple plastic stents to
      fully covered self expanding metal stents in the palliation of distal malignant biliary
      obstruction in patients with irresectable tumours.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients without stent failure
time frame: 12 months
description: Number of patients without Stent failure (jaundice) or death with a patent stent
measure: Overall survival
time frame: 12 months
description: Number of patietns alive in each group at 12 months
measure: Stent deployment failure
time frame: During procedure
description: Number of patients in whom there was failure to deploy the assigned stent(s) after randomisation
measure: Cost
time frame: 12 months
description: The differance in treatment costs between the two groups, measured in USD
arm group label: Multiple Plastic Stents
arm group type: Active Comparator
description: Patients will receive two 8.5Fr Platic biliary stents placed side by side across the biliary stricture.
arm group label: Self-expandable Metal Stents
arm group type: Active Comparator
description: Patients will receive a fully covered Self-expandable Metal Stents (10mm) across the biliary stricture
intervention type: Device
intervention name: Biliary stent
description: Palliation of malignant biliary obstruction
arm group label: Multiple Plastic Stents
arm group label: Self-expandable Metal Stents
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc M Bernon, MBBCh
phone: +27 (0)21 404 3042
email: mm.bernon@uct.ac.za
facility: 
status: Recruiting
contact: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: University of Cape Town
investigator full name: Marc Bernon
investigator title: Senior consultant
mesh term: Pancreatic Neoplasms
mesh term: Bile Duct Neoplasms
mesh term: Cholestasis
mesh term: Cholestasis, Extrahepatic
sharing ipd: No