<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/NCT01675908</url>
  </required_header>
  <id_info>
    <org_study_id>356090</org_study_id>
    <nct_id>NCT01675908</nct_id>
  </id_info>
  <brief_title>Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression</brief_title>
  <official_title>Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AdventHealth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AdventHealth</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare the performance of full covered metal stents and plastic stents for preoperative&#xD;
      biliary decompression&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr&#xD;
      plastic stents. When compared to plastic stents, randomized trials have shown longer patency&#xD;
      and fewer stent-related complications for CSEMS. The investigators hypothesize that placement&#xD;
      of CSEMS would be a better treatment option for preoperative biliary decompression in&#xD;
      patients with pancreatic cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2012</start_date>
  <completion_date type="Actual">August 21, 2019</completion_date>
  <primary_completion_date type="Actual">August 21, 2019</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>Complications related to stent dysfunction</measure>
    <time_frame>30 days</time_frame>
    <description>Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedural complications</measure>
    <time_frame>30 days</time_frame>
    <description>This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Obstructive Jaundice</condition>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Metal stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plastic Stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stent Dysfunction</intervention_name>
    <description>Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.</description>
    <arm_group_label>Metal stent</arm_group_label>
    <arm_group_label>Plastic Stent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Complications</intervention_name>
    <description>Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.</description>
    <arm_group_label>Metal stent</arm_group_label>
    <arm_group_label>Plastic Stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
          1. Patients with pancreatic cancer and mass in the head of pancreas causing jaundice.&#xD;
&#xD;
          2. Patients 19 yrs of age and older&#xD;
&#xD;
          3. Serum bilirubin &gt; 2mg/dl&#xD;
&#xD;
          4. CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding&#xD;
             portal or mesenteric vessels for more than 180 degrees of their circumference or an&#xD;
             irregular vessel margin).&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          1. Karnofsky score &lt; 60&#xD;
&#xD;
          2. Prior (ERCP or PTC) attempts at biliary decompression for the same indication&#xD;
&#xD;
          3. Tumor-related gastric outlet obstruction (vomiting and oral intake of &lt; 1L/day)&#xD;
&#xD;
          4. Ongoing or planned neoadjuvant therapy&#xD;
&#xD;
          5. Cholangitis at presentation or coagulopathy needing reversal medication&#xD;
&#xD;
          6. Post-surgical anatomy&#xD;
&#xD;
          7. Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum&#xD;
&#xD;
          8. Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC&#xD;
             or surgery).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>shyam varadarajulu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida Hospital Center for Interventional Endoscopy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>February 15, 2022</last_update_submitted>
  <last_update_submitted_qc>February 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2022</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>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Jaundice</mesh_term>
    <mesh_term>Jaundice, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>A manuscript will be developed following completion of the study.</ipd_description>
  </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/NCT01675908
org study id: 356090
nct id: NCT01675908
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Compare the performance of full covered metal stents and plastic stents for preoperative
      biliary decompression
Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr
      plastic stents. When compared to plastic stents, randomized trials have shown longer patency
      and fewer stent-related complications for CSEMS. The investigators hypothesize that placement
      of CSEMS would be a better treatment option for preoperative biliary decompression in
      patients with pancreatic cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complications related to stent dysfunction
time frame: 30 days
description: Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.
measure: Procedural complications
time frame: 30 days
description: This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage.
arm group label: Metal stent
arm group type: Active Comparator
description: Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated.
arm group label: Plastic Stent
arm group type: Active Comparator
description: At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.
intervention type: Procedure
intervention name: Stent Dysfunction
description: Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.
arm group label: Metal stent
arm group label: Plastic Stent
intervention type: Procedure
intervention name: Complications
description: Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.
arm group label: Metal stent
arm group label: Plastic Stent
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: shyam varadarajulu, MD
role: Principal Investigator
affiliation: Florida Hospital Center for Interventional Endoscopy
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Jaundice
mesh term: Jaundice, Obstructive
sharing ipd: No
ipd description: A manuscript will be developed following completion of the study.