<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/NCT03763214</url>
  </required_header>
  <id_info>
    <org_study_id>JWGUHMED1-009</org_study_id>
    <nct_id>NCT03763214</nct_id>
  </id_info>
  <brief_title>PTFE Stents for Treatment of Malignant Biliary Strictures</brief_title>
  <official_title>Randomized Comparative Study of Novel PTFE-coated Stents (Hilzo) Versus Standard Silicone-coated Metal Stents (cSEMS) in Distal Malignant DHC Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Vermehren</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Robert Bosch Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Klinikum Stadt Hanau</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johann Wolfgang Goethe University Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this randomized trial two two self-expanding metal stents (SEMS) for treatment of&#xD;
      malignant biliary strictures are investigated.&#xD;
&#xD;
      A newly developed PTFE (Polytetrafluorethylen) (Teflon) stent is tested versus standard&#xD;
      covered metal stents. PFTE (Teflon) coating promises improved formability over standard&#xD;
      silicone-coated stents, easier removal through the soft surface, and significantly reduced&#xD;
      tumor growth through the impermeable surface.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ERCP (endoscopic retrograde cholangiopancreatography) is the standard method of treating&#xD;
      diseases in the biliopancreatic system and the treatment goal is achieved in a very high&#xD;
      proportion of the studies. The ERCP is based on the indirect imaging of the bile ducts by&#xD;
      injection of contrast medium, which is visualized in X-ray fluoroscopy. Furthermore, the&#xD;
      probing of the bile ducts by means of wire and direct interventions within the bile duct&#xD;
      system is possible.&#xD;
&#xD;
      Malignant biliary strictures are caused by various, usually cholangiocellular or pancreatic&#xD;
      tumors, whose surgical therapy is complex and often impossible due to advanced disease.&#xD;
      Tumors of the papillae, lymphomas and lymph node metastases can also lead to stenosis of the&#xD;
      extra hepatic bile ducts.&#xD;
&#xD;
      The outcome of patients with malignant biliary strictures is poor, most are already&#xD;
      presenting with advanced disease because early symptoms are rare. In particular, the&#xD;
      above-mentioned cholangiocellular carcinomas and pancreatic carcinomas are often resectable&#xD;
      only in its early form with high recurrence rates. Furthermore, then only palliative concepts&#xD;
      are possible. Various studies have shown that stenting of the biliary tract with drainage of&#xD;
      more than 50% of the liver volume improves survival. Metal stents seem to be superior to&#xD;
      plastic stents at a slightly higher cholangitis rate. It is therefore considered standard&#xD;
      therapy to palliatively treat these patients with more than 3 months of life expectancy using&#xD;
      a metal stent.&#xD;
&#xD;
      Two types of stents are currently in use, plastic stents and self-expanding metal stents&#xD;
      (SEMS). These in turn are coated (cSEMS) and uncoated (uSEMS). In distal malignant stenosis,&#xD;
      both cSEMS and uSEMS can be used, with a higher patency rate for cSEMS and a longer duration&#xD;
      of uSEMS retention. The disadvantage of the uSEMS is the tumor ingrowth in the stents and the&#xD;
      possibility of re-stenosis. Various studies have shown that metal stents are associated with&#xD;
      better bile duct drainage and better retention time compared to plastic stents and have fewer&#xD;
      early complications, however, a consensus regarding a survival advantage with metal stents&#xD;
      has not yet been substantiated, with the data showing a positive trend. Since metal stents,&#xD;
      unlike plastic stents, do not need to be changed, a significant advantage for the patient is&#xD;
      the significant reduction in endoscopic examinations and associated hospitalization and&#xD;
      complication rates.&#xD;
&#xD;
      PTFE stents are a new development that should significantly reduce tumor ingrowth into the&#xD;
      stent and, in particular, allow for a significantly reduced stent migration rate. PFTE&#xD;
      (Teflon) coating promises improved formability over standard silicone-coated stents, easier&#xD;
      removal through the soft surface, and significantly reduced tumor growth through the&#xD;
      impermeable surface. At both ends of the stents are &quot;tulips&quot; which are coated with silicone.&#xD;
      This in turn reduces the rate of stent closure by sludge, and in particular, the otherwise&#xD;
      very high rate of stent migration should be significantly reduced.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">March 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>
    <intervention_model_description>Randomized, two arms</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stent migration</measure>
    <time_frame>12 month</time_frame>
    <description>Rate of stent migrations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stent dysfunction (re-stenosis)</measure>
    <time_frame>12 month</time_frame>
    <description>Stenosis of stent with necessity to do duodenoscopy again</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ERCPs in one year</measure>
    <time_frame>12 month</time_frame>
    <description>Count of the number of duodenoscopy the patients undergo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival rate</measure>
    <time_frame>12 month</time_frame>
    <description>Survival of patientes 12 month after the procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Bile Duct Stricture</condition>
  <condition>Bile Duct Cancer</condition>
  <condition>Pancreas Cancer</condition>
  <arm_group>
    <arm_group_label>Stenting with PTFE-coated stent (HILZO)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The bile duct is stented with a PTFE-coated stent by duodenoscopy to allow bile duct flow</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stenting standard silicone coated stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The bile duct is stented with a standard silicone-coated stent by duodenoscopy to allow bile duct flow</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stenting with PTFE-coated stent (HILZO)</intervention_name>
    <description>Placing a metal stent in the biliary tract by duodenoscopy</description>
    <arm_group_label>Stenting standard silicone coated stent</arm_group_label>
    <arm_group_label>Stenting with PTFE-coated stent (HILZO)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Indication for the palliative metal-stent system for malignant stenosis of the distal DHC&#xD;
        (bile duct tumors, pancreatic carcinoma, papillary carcinoma, lymphoma, lymph node&#xD;
        metastases in the hilum)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18 years&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Contraindication to an endoscopic examination&#xD;
&#xD;
          -  Life expectancy under 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mireen Friedrich-Rust, Prof.</last_name>
    <phone>069-6301-0</phone>
    <email>mireen.friedrich-rust@kgu.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fabian Finkelmeier, Dr.</last_name>
    <phone>069-6301-0</phone>
    <email>fabian.finkelmeier@kgu.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Klinikum der J. W. Goethe-Universität</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mireen Friedrich-Rust, MD</last_name>
      <email>Mireen.Friedrich-Rust@kgu.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>May 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 1, 2018</last_update_submitted>
  <last_update_submitted_qc>December 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Johann Wolfgang Goethe University Hospital</investigator_affiliation>
    <investigator_full_name>Johannes Vermehren</investigator_full_name>
    <investigator_title>Record Keeper, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>metal stent</keyword>
  <keyword>biliary stricture</keyword>
  <keyword>stenting</keyword>
  <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>Cholangiocarcinoma</mesh_term>
    <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/NCT03763214
org study id: JWGUHMED1-009
nct id: NCT03763214
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this randomized trial two two self-expanding metal stents (SEMS) for treatment of
      malignant biliary strictures are investigated.

      A newly developed PTFE (Polytetrafluorethylen) (Teflon) stent is tested versus standard
      covered metal stents. PFTE (Teflon) coating promises improved formability over standard
      silicone-coated stents, easier removal through the soft surface, and significantly reduced
      tumor growth through the impermeable surface.
ERCP (endoscopic retrograde cholangiopancreatography) is the standard method of treating
      diseases in the biliopancreatic system and the treatment goal is achieved in a very high
      proportion of the studies. The ERCP is based on the indirect imaging of the bile ducts by
      injection of contrast medium, which is visualized in X-ray fluoroscopy. Furthermore, the
      probing of the bile ducts by means of wire and direct interventions within the bile duct
      system is possible.

      Malignant biliary strictures are caused by various, usually cholangiocellular or pancreatic
      tumors, whose surgical therapy is complex and often impossible due to advanced disease.
      Tumors of the papillae, lymphomas and lymph node metastases can also lead to stenosis of the
      extra hepatic bile ducts.

      The outcome of patients with malignant biliary strictures is poor, most are already
      presenting with advanced disease because early symptoms are rare. In particular, the
      above-mentioned cholangiocellular carcinomas and pancreatic carcinomas are often resectable
      only in its early form with high recurrence rates. Furthermore, then only palliative concepts
      are possible. Various studies have shown that stenting of the biliary tract with drainage of
      more than 50% of the liver volume improves survival. Metal stents seem to be superior to
      plastic stents at a slightly higher cholangitis rate. It is therefore considered standard
      therapy to palliatively treat these patients with more than 3 months of life expectancy using
      a metal stent.

      Two types of stents are currently in use, plastic stents and self-expanding metal stents
      (SEMS). These in turn are coated (cSEMS) and uncoated (uSEMS). In distal malignant stenosis,
      both cSEMS and uSEMS can be used, with a higher patency rate for cSEMS and a longer duration
      of uSEMS retention. The disadvantage of the uSEMS is the tumor ingrowth in the stents and the
      possibility of re-stenosis. Various studies have shown that metal stents are associated with
      better bile duct drainage and better retention time compared to plastic stents and have fewer
      early complications, however, a consensus regarding a survival advantage with metal stents
      has not yet been substantiated, with the data showing a positive trend. Since metal stents,
      unlike plastic stents, do not need to be changed, a significant advantage for the patient is
      the significant reduction in endoscopic examinations and associated hospitalization and
      complication rates.

      PTFE stents are a new development that should significantly reduce tumor ingrowth into the
      stent and, in particular, allow for a significantly reduced stent migration rate. PFTE
      (Teflon) coating promises improved formability over standard silicone-coated stents, easier
      removal through the soft surface, and significantly reduced tumor growth through the
      impermeable surface. At both ends of the stents are "tulips" which are coated with silicone.
      This in turn reduces the rate of stent closure by sludge, and in particular, the otherwise
      very high rate of stent migration should be significantly reduced.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, two arms
primary purpose: Treatment
masking: None (Open Label)
measure: Stent migration
time frame: 12 month
description: Rate of stent migrations
measure: Stent dysfunction (re-stenosis)
time frame: 12 month
description: Stenosis of stent with necessity to do duodenoscopy again
measure: Number of ERCPs in one year
time frame: 12 month
description: Count of the number of duodenoscopy the patients undergo
measure: Survival rate
time frame: 12 month
description: Survival of patientes 12 month after the procedure
arm group label: Stenting with PTFE-coated stent (HILZO)
arm group type: Experimental
description: The bile duct is stented with a PTFE-coated stent by duodenoscopy to allow bile duct flow
arm group label: Stenting standard silicone coated stent
arm group type: Active Comparator
description: The bile duct is stented with a standard silicone-coated stent by duodenoscopy to allow bile duct flow
intervention type: Device
intervention name: Stenting with PTFE-coated stent (HILZO)
description: Placing a metal stent in the biliary tract by duodenoscopy
arm group label: Stenting standard silicone coated stent
arm group label: Stenting with PTFE-coated stent (HILZO)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Mireen Friedrich-Rust, Prof.
phone: 069-6301-0
email: mireen.friedrich-rust@kgu.de
last name: Fabian Finkelmeier, Dr.
phone: 069-6301-0
email: fabian.finkelmeier@kgu.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Johann Wolfgang Goethe University Hospital
investigator full name: Johannes Vermehren
investigator title: Record Keeper, Clinical Professor
mesh term: Pancreatic Neoplasms
mesh term: Bile Duct Neoplasms
mesh term: Cholangiocarcinoma
mesh term: Constriction, Pathologic