<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/NCT03788655</url>
  </required_header>
  <id_info>
    <org_study_id>JWGUHMED1-010</org_study_id>
    <nct_id>NCT03788655</nct_id>
  </id_info>
  <brief_title>Metal Stents (Moving Cell Stent) for Inoperable Tumors of the Bile Duct Tract</brief_title>
  <official_title>Feasibility Study on Novel Metal Stents (Moving Cell Stent) for Inoperable Tumors of the Bile Duct Tract</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Vermehren</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <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 feasibility study (non-randomized), the applicability of a new &quot;moving cell&quot; biliary&#xD;
      stents (by HILZO) in Klatskin tumors (bile duct obstruction) will be investigated.&#xD;
&#xD;
      The HILZO Moving-Cell Stent to be examined here is a non-coated metal stent with a novelty.&#xD;
      The meshes have a diameter of 4 mm, which is rather small compared to most other stents. This&#xD;
      significantly increases the radial force and thus the stability of the stent. Furthermore,&#xD;
      ingrowth by tumors in the stent is difficult. The special feature is that the individual&#xD;
      meshes can easily be stretched to 10 mm without changing the stability of the stent. This&#xD;
      allows a second stent to pass through the first to another segment of liver.&#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;
      The HILZO Moving-Cell Stent to be examined here is a non-coated metal stent with a novelty.&#xD;
      The meshes have a diameter of 4 mm, which is rather small compared to most other stents. This&#xD;
      significantly increases the radial force and thus the stability of the stent. Furthermore,&#xD;
      ingrowth by tumors in the stent is difficult. The special feature is that the individual&#xD;
      meshes can easily be stretched to 10 mm without changing the stability of the stent. This&#xD;
      allows a second stent to pass through the first to another segment of liver. Previous metal&#xD;
      stents could previously only be placed side by side in the common bile duct, thereby limiting&#xD;
      the number of stents as a function of the gait and the stents can develop worse in the main&#xD;
      course.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">December 31, 2018</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Technical feasibility of intrahepatic stenting</measure>
    <time_frame>12 month</time_frame>
    <description>Successful biliary drainage by new stent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of drained segments</measure>
    <time_frame>12</time_frame>
    <description>Number of successful drained liver segments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of intervention</measure>
    <time_frame>12 month</time_frame>
    <description>Length of the endoscopy with the new stent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent dysfunction</measure>
    <time_frame>12 month</time_frame>
    <description>Stent migration or stenosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of necessary endoscopies per year</measure>
    <time_frame>12 month</time_frame>
    <description>Number of necessary endoscopies per year to have successful drainage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival rate</measure>
    <time_frame>12 month</time_frame>
    <description>Survival of patients 12 month after the procedure</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Bile Duct Stricture</condition>
  <condition>Bile Duct Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with the indication for palliative stenting of the bile duct system due to&#xD;
        non-operable Klatskin tumors type II-IV&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Indication for the palliative metal-stent system for malignant stenosis due to biliary&#xD;
        cancer (Klatskin tumor).&#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_official>
    <last_name>Mireen Friedrich-Rust, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Clinic Frankfurt am Main</affiliation>
  </overall_official>
  <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, Prof.</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>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>December 25, 2018</last_update_submitted>
  <last_update_submitted_qc>December 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 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>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/NCT03788655
org study id: JWGUHMED1-010
nct id: NCT03788655
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this feasibility study (non-randomized), the applicability of a new "moving cell" biliary
      stents (by HILZO) in Klatskin tumors (bile duct obstruction) will be investigated.

      The HILZO Moving-Cell Stent to be examined here is a non-coated metal stent with a novelty.
      The meshes have a diameter of 4 mm, which is rather small compared to most other stents. This
      significantly increases the radial force and thus the stability of the stent. Furthermore,
      ingrowth by tumors in the stent is difficult. The special feature is that the individual
      meshes can easily be stretched to 10 mm without changing the stability of the stent. This
      allows a second stent to pass through the first to another segment of liver.
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.

      The HILZO Moving-Cell Stent to be examined here is a non-coated metal stent with a novelty.
      The meshes have a diameter of 4 mm, which is rather small compared to most other stents. This
      significantly increases the radial force and thus the stability of the stent. Furthermore,
      ingrowth by tumors in the stent is difficult. The special feature is that the individual
      meshes can easily be stretched to 10 mm without changing the stability of the stent. This
      allows a second stent to pass through the first to another segment of liver. Previous metal
      stents could previously only be placed side by side in the common bile duct, thereby limiting
      the number of stents as a function of the gait and the stents can develop worse in the main
      course.
observational model: Cohort
time perspective: Prospective
measure: Technical feasibility of intrahepatic stenting
time frame: 12 month
description: Successful biliary drainage by new stent
measure: Number of drained segments
time frame: 12
description: Number of successful drained liver segments
measure: Length of intervention
time frame: 12 month
description: Length of the endoscopy with the new stent
measure: Stent dysfunction
time frame: 12 month
description: Stent migration or stenosis
measure: Number of necessary endoscopies per year
time frame: 12 month
description: Number of necessary endoscopies per year to have successful drainage
measure: Survival rate
time frame: 12 month
description: Survival of patients 12 month after the procedure
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Mireen Friedrich-Rust, Prof.
role: Principal Investigator
affiliation: University Clinic Frankfurt am Main
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: Bile Duct Neoplasms
mesh term: Cholangiocarcinoma
mesh term: Constriction, Pathologic