<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/NCT04420039</url>
  </required_header>
  <id_info>
    <org_study_id>HUBellvitge</org_study_id>
    <nct_id>NCT04420039</nct_id>
  </id_info>
  <brief_title>Plastic Stent Within a Lumen-Apposing Stent for Malignant Biliary Obstruction</brief_title>
  <acronym>LAMSpigBil</acronym>
  <official_title>Is Useful a Coaxial Plastic Stent Within a Lumen-Apposing Metal Stent For The Palliative Management Of Malignant Biliary Obstruction?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari de Bellvitge</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Mutua de Terrassa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut d'Investigació Biomèdica de Bellvitge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitari de Bellvitge</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are doubts concerning the possible benefits derived from the insertion of&#xD;
      double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the&#xD;
      EUS-guided transmural biliary drainage (BD). The aims was to evaluate the safety of LAMS with&#xD;
      and without a coaxial DPS in EUS-BD for the palliative management in malignant biliary&#xD;
      obstruction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">March 2021</completion_date>
  <primary_completion_date type="Actual">September 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Potential benefits</measure>
    <time_frame>4 weeks</time_frame>
    <description>to respond if a coaxial DPS within a biliary LAMS really has a potential benefit in the EUS-BD (less number of adverse events: cholangitis, bleeding, sump syndrome, cholestasis secondary to stent biliary obstruction)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical success</measure>
    <time_frame>24 hours</time_frame>
    <description>Technical success was defined as a successful stent placement between the extrahepatic bile duct and duodenal lumen in a single step approach and determined by endoscopy and fluoroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>4 weeks</time_frame>
    <description>Clinical success was defined as a reduction in bilirubin by 50% at 2-weeks after stent placement, meaning that the biliary stent was functional.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>2 hours</time_frame>
    <description>Procedure time was defined from the insertion of the endoscope to its removal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biliary reintervention</measure>
    <time_frame>6 months</time_frame>
    <description>Biliary reintervention: the need to perform additional interventions to achieve biliary drainage.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">39</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Endoscopy</condition>
  <condition>Oncologic Disorders</condition>
  <condition>Therapy Related Neoplasms</condition>
  <arm_group>
    <arm_group_label>1- Single biliary LAMS</arm_group_label>
    <description>Unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD with a single lumen-apposing stent after failed ERCP cannulation or inaccessible papilla.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2- Biliary LAMS plus Doublu-Pigtail plastic Etent</arm_group_label>
    <description>Unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD with a single lumen-apposing stent (plus double-pigtail plastic stent) after failed ERCP cannulation or inaccessible papilla.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endoscopic biliary transmural drainage</intervention_name>
    <description>Endosonography-guided biliodigestive anastomosis using a dedicated biliary lumen-apposing stent in order to proveide a biliary drainage in cases of palliative malignant biliary obstruction.&#xD;
Two different strategies will be compared: single lumen-apposing stent vs lumen-apposing stent plus dousble-pigtail plastic stent.</description>
    <arm_group_label>1- Single biliary LAMS</arm_group_label>
    <arm_group_label>2- Biliary LAMS plus Doublu-Pigtail plastic Etent</arm_group_label>
    <other_name>Endoscopic Ultrasound-guided biliary drainage</other_name>
    <other_name>Choledochoduodenostomy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Palliative malignant biliopancreatic pathology&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive unresectable/inoperable biliopancreatic cases with distal biliary&#xD;
             obstruction who underwent EUS-BD after failed ERCP cannulation or inaccessible papilla&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Borderline cancer cases&#xD;
&#xD;
          -  Others type of biliary stents&#xD;
&#xD;
          -  Severe coagulopathy or thrombocytopenia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Universitari Mútua de Terrassa</name>
      <address>
        <city>Terrassa</city>
        <state>Barcelona, Catalonia</state>
        <zip>08221</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Sant Pau i de la Santa Creu</name>
      <address>
        <city>Barcelona</city>
        <state>Catalonia</state>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 11, 2021</last_update_submitted>
  <last_update_submitted_qc>July 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitari de Bellvitge</investigator_affiliation>
    <investigator_full_name>Joan B Gornals</investigator_full_name>
    <investigator_title>Programme Director, Endoscopy Area, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Malignant biliary obstrucction</keyword>
  <keyword>Therapeutic endoscopy</keyword>
  <keyword>Biliary drainage</keyword>
  <keyword>Lumen apposing stent</keyword>
  <keyword>Endoscopic Ultrasound</keyword>
  <keyword>Pancreatic neoplasm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms, Second Primary</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/NCT04420039
org study id: HUBellvitge
nct id: NCT04420039
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
There are doubts concerning the possible benefits derived from the insertion of
      double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the
      EUS-guided transmural biliary drainage (BD). The aims was to evaluate the safety of LAMS with
      and without a coaxial DPS in EUS-BD for the palliative management in malignant biliary
      obstruction.
observational model: Cohort
time perspective: Retrospective
measure: Potential benefits
time frame: 4 weeks
description: to respond if a coaxial DPS within a biliary LAMS really has a potential benefit in the EUS-BD (less number of adverse events: cholangitis, bleeding, sump syndrome, cholestasis secondary to stent biliary obstruction)
measure: Technical success
time frame: 24 hours
description: Technical success was defined as a successful stent placement between the extrahepatic bile duct and duodenal lumen in a single step approach and determined by endoscopy and fluoroscopy
measure: Clinical success
time frame: 4 weeks
description: Clinical success was defined as a reduction in bilirubin by 50% at 2-weeks after stent placement, meaning that the biliary stent was functional.
measure: Procedure time
time frame: 2 hours
description: Procedure time was defined from the insertion of the endoscope to its removal.
measure: Biliary reintervention
time frame: 6 months
description: Biliary reintervention: the need to perform additional interventions to achieve biliary drainage.
arm group label: 1- Single biliary LAMS
description: Unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD with a single lumen-apposing stent after failed ERCP cannulation or inaccessible papilla.
arm group label: 2- Biliary LAMS plus Doublu-Pigtail plastic Etent
description: Unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD with a single lumen-apposing stent (plus double-pigtail plastic stent) after failed ERCP cannulation or inaccessible papilla.
intervention type: Device
intervention name: Endoscopic biliary transmural drainage
description: Endosonography-guided biliodigestive anastomosis using a dedicated biliary lumen-apposing stent in order to proveide a biliary drainage in cases of palliative malignant biliary obstruction.
Two different strategies will be compared: single lumen-apposing stent vs lumen-apposing stent plus dousble-pigtail plastic stent.
arm group label: 1- Single biliary LAMS
arm group label: 2- Biliary LAMS plus Doublu-Pigtail plastic Etent
other name: Endoscopic Ultrasound-guided biliary drainage
other name: Choledochoduodenostomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitari de Bellvitge
investigator full name: Joan B Gornals
investigator title: Programme Director, Endoscopy Area, MD, PhD
mesh term: Neoplasms, Second Primary
sharing ipd: No