<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/NCT04403893</url>
  </required_header>
  <id_info>
    <org_study_id>2753</org_study_id>
    <nct_id>NCT04403893</nct_id>
  </id_info>
  <brief_title>Feasibility and Safety of a Dedicated Biliary Stent for Transmural EUS-guided Hepatico-gastrostomy: the FIT Study</brief_title>
  <acronym>FIT</acronym>
  <official_title>Feasibility and Safety of a Dedicated Biliary Stent for Transmural EUS-guided Hepatico-gastrostomy: the FIT Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Clinico Humanitas</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>
      One of the major roles of interventional EUS is biliary drainage (EUS-BD) as an alternative&#xD;
      to ERCP-based biliary decompression.&#xD;
&#xD;
      In fact, even when performed by expert endoscopists, ERCP-based stenting fails in 5% of&#xD;
      cases. In these cases, standard alternative approaches include surgical bypass and&#xD;
      percutaneous transhepatic cholangiography and biliary drainage (PTBD). However, these&#xD;
      procedures are associated with higher patient discomfort and prolonged hospital stay.&#xD;
&#xD;
      The most diffuse approach for EUS-BD are choledochoduodenostomy (CDS) or hepaticogastrostomy&#xD;
      (HGS). As a matter of fact, since dedicate devices as lumen apposing metal stents (LAMS),&#xD;
      have been adopted for CDS, we have been witnessing the escalation of such procedure.&#xD;
&#xD;
      On the other hand, the diffusion of EUS-HGS is still limited due to the complexity of the&#xD;
      procedure and the lack of dedicated devices. However, recently a dedicated stent was&#xD;
      conceived as asymmetrically covered and shaped in order to have its uncovered, tubular end&#xD;
      into the intrahepatic ducts and the covered, flanged end into the gastric cavity, to reduce&#xD;
      the risk of migration. The developement of such stent could further increase both the&#xD;
      technical feasibility and the clinical outcomes of HGS in order to explore the whole&#xD;
      potential of this procedure and to definitively find its role in biliary drainage algorithm.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>AE and SAE events</measure>
    <time_frame>12 Months</time_frame>
    <description>To assess the technical safety for EUS-guided hepaticogastrostomy.</description>
  </primary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Malignant Bilio-pancreatic Diseases</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HANARO biliary stent placement</intervention_name>
    <description>HANARO biliary stent placement</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with malignant bilio-pancreatic diseases with an indication to undergo biliary&#xD;
        stent positioning for biliary drainage after ERCP failure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • subjects with malignant bilio-pancreatic diseases with an indication to undergo biliary&#xD;
        stent positioning for biliary drainage after ERCP failure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 y&#xD;
&#xD;
          -  Contra-indication for endoscopy or interventional radiology&#xD;
&#xD;
          -  Unsigned informing consent form, ICF&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Endoscopy Unit, Humanitas Research Hospital</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 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 Diseases</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/NCT04403893
org study id: 2753
nct id: NCT04403893
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
One of the major roles of interventional EUS is biliary drainage (EUS-BD) as an alternative
      to ERCP-based biliary decompression.

      In fact, even when performed by expert endoscopists, ERCP-based stenting fails in 5% of
      cases. In these cases, standard alternative approaches include surgical bypass and
      percutaneous transhepatic cholangiography and biliary drainage (PTBD). However, these
      procedures are associated with higher patient discomfort and prolonged hospital stay.

      The most diffuse approach for EUS-BD are choledochoduodenostomy (CDS) or hepaticogastrostomy
      (HGS). As a matter of fact, since dedicate devices as lumen apposing metal stents (LAMS),
      have been adopted for CDS, we have been witnessing the escalation of such procedure.

      On the other hand, the diffusion of EUS-HGS is still limited due to the complexity of the
      procedure and the lack of dedicated devices. However, recently a dedicated stent was
      conceived as asymmetrically covered and shaped in order to have its uncovered, tubular end
      into the intrahepatic ducts and the covered, flanged end into the gastric cavity, to reduce
      the risk of migration. The developement of such stent could further increase both the
      technical feasibility and the clinical outcomes of HGS in order to explore the whole
      potential of this procedure and to definitively find its role in biliary drainage algorithm.
observational model: Cohort
time perspective: Prospective
measure: AE and SAE events
time frame: 12 Months
description: To assess the technical safety for EUS-guided hepaticogastrostomy.
intervention type: Other
intervention name: HANARO biliary stent placement
description: HANARO biliary stent placement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Pancreatic Diseases
sharing ipd: No