<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/NCT03282539</url>
  </required_header>
  <id_info>
    <org_study_id>LAMSpig1</org_study_id>
    <nct_id>NCT03282539</nct_id>
  </id_info>
  <brief_title>Lumen Apposing Metal Stents With and Without a Double Pigtail Stent in Pancreatic Collections</brief_title>
  <official_title>Lumen Apposing Metal Stents With and Without a Coaxial Double Pigtail Stent in the Management of Pancreatic Fluid Collections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari de Bellvitge</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari de Bellvitge</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study evaluates the security of LAMS with ando without a coaxial double pigtail plastic&#xD;
      stent in the management of pancreatic fuid collections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The introduction of lumen-apposing metal stents (LAMS) represented a great improvement in the&#xD;
      EUS-guided transmural drainage of pancreatic fluid collections (PFCs). It is postulated safer&#xD;
      than other types of stents due to the presence of bilateral anchoring flanges, designed to&#xD;
      appose the stomach or duodenum to the PFC wall minimizing the risk of perforation or&#xD;
      peritoneal leakage. In addition, the larger lumen diameter facilitates the drainage of PFC,&#xD;
      specially the walled-off pancreatic necrosis (WOPN). However, secondary adverse effects such&#xD;
      as infection due to complete or partial stent obstruction, migration, bleeding or buried LAMS&#xD;
      syndrome have also been related . The placement of a coaxial double pigtail plastic within&#xD;
      the LAMS has been reported beneficial in order to avoid external migration or the lumen&#xD;
      obstruction and to the prevention of bleeding and other adverse events. The aim of this study&#xD;
      was to evaluate the efficacy and safety of LAMS with and without a coaxial double pigtail&#xD;
      plastic stent in the EUS-guided transmural drainage of PFCs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2011</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Adverse events</measure>
    <time_frame>Outcomes will be assessed 6 months after the inclusion of last patient.</time_frame>
    <description>Defined and graded according to the ASGE lexicon's severity grading system</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">37</enrollment>
  <condition>Pancreatic Collection</condition>
  <arm_group>
    <arm_group_label>LAMS</arm_group_label>
    <description>EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LAMS + pigtail</arm_group_label>
    <description>EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents and a coaxial double pigtail stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LAMS</intervention_name>
    <description>EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents</description>
    <arm_group_label>LAMS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LAMS + pigtail</intervention_name>
    <description>EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents and a coaxial double pigtail stent</description>
    <arm_group_label>LAMS + pigtail</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients wiht pancreatic fluid collections and indication for EUS-guided transmural&#xD;
        drainage in accordance l wiht international creteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with pancreatic fluid collections and indication of drainage.&#xD;
&#xD;
          -  EUS-guided trasmural drainage wiht lumen apposing metal stents.&#xD;
&#xD;
          -  Criteria for drainage were as specified by the Working Group of the International&#xD;
             Association of Pancreatology.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other types of collections and stents&#xD;
&#xD;
          -  Severe coagulopathy (protombin time &gt; 1,5) or thrombocytopenia (platelet count &lt; 50 x&#xD;
             109/L)&#xD;
&#xD;
          -  PFCs with a previous attempt failed of EUS-guided transmural drainage&#xD;
&#xD;
          -  Age younger than 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joan Gornals</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitari de Bellvitge</affiliation>
  </overall_official>
  <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_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</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>PhD</investigator_title>
  </responsible_party>
  <keyword>Lumen apposing metal stents</keyword>
  <keyword>Double pigtail stents</keyword>
  <keyword>Endoscopic ultrasonography</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The results of the stuydy will be shared with other researchers.</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/NCT03282539
org study id: LAMSpig1
nct id: NCT03282539
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The study evaluates the security of LAMS with ando without a coaxial double pigtail plastic
      stent in the management of pancreatic fuid collections.
The introduction of lumen-apposing metal stents (LAMS) represented a great improvement in the
      EUS-guided transmural drainage of pancreatic fluid collections (PFCs). It is postulated safer
      than other types of stents due to the presence of bilateral anchoring flanges, designed to
      appose the stomach or duodenum to the PFC wall minimizing the risk of perforation or
      peritoneal leakage. In addition, the larger lumen diameter facilitates the drainage of PFC,
      specially the walled-off pancreatic necrosis (WOPN). However, secondary adverse effects such
      as infection due to complete or partial stent obstruction, migration, bleeding or buried LAMS
      syndrome have also been related . The placement of a coaxial double pigtail plastic within
      the LAMS has been reported beneficial in order to avoid external migration or the lumen
      obstruction and to the prevention of bleeding and other adverse events. The aim of this study
      was to evaluate the efficacy and safety of LAMS with and without a coaxial double pigtail
      plastic stent in the EUS-guided transmural drainage of PFCs.
observational model: Cohort
time perspective: Prospective
measure: Adverse events
time frame: Outcomes will be assessed 6 months after the inclusion of last patient.
description: Defined and graded according to the ASGE lexicon's severity grading system
arm group label: LAMS
description: EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents.
arm group label: LAMS + pigtail
description: EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents and a coaxial double pigtail stent
intervention type: Device
intervention name: LAMS
description: EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents
arm group label: LAMS
intervention type: Device
intervention name: LAMS + pigtail
description: EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents and a coaxial double pigtail stent
arm group label: LAMS + pigtail
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joan Gornals
role: Principal Investigator
affiliation: Hospital Universitari de Bellvitge
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitari de Bellvitge
investigator full name: JOAN B GORNALS
investigator title: PhD
sharing ipd: No
ipd description: The results of the stuydy will be shared with other researchers.