<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/NCT01673763</url>
  </required_header>
  <id_info>
    <org_study_id>240179</org_study_id>
    <nct_id>NCT01673763</nct_id>
  </id_info>
  <brief_title>Post-ERCP Pancreatitis Prevention by Stent Insertion</brief_title>
  <acronym>PEPSI</acronym>
  <official_title>Study to Reduce Incidence of Post-ERCP Pancreatitis by Stent Insertion in the Main Pancreatic Duct After Unintended Cannulation of the Main Pancreatic Duct</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northern State University, Russia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Latvijas Universitates Medicinas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Technical University of Munich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The presented study is designed to analyze the efficacy of pancreatic stent insertion in&#xD;
      patients undergoing ERCP with accidental cannulation of the pancreatic duct.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2010</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">June 2016</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of post-ERCP pancreatitis</measure>
    <time_frame>up to 1 week</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">169</enrollment>
  <condition>Post-ERCP Acute Pancreatitis</condition>
  <arm_group>
    <arm_group_label>Stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stent insertion into the main pancreatic duct</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No stent</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No stent insertion into the main pancreatic duct</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stent insertion into the main pancreatic duct</intervention_name>
    <description>Stent insertion into the main pancreatic duct</description>
    <arm_group_label>Stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients undergoing ERCP with unintended cannulation or opifiacation of main&#xD;
             pancreatic duct&#xD;
&#xD;
          -  age &gt; 17 years&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intention to intervene main pancreatic duct&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  absent of signed informed consent&#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>Hana Algül, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>II. Medizinische Klinik, Klinikum rechts der Isar, Ismaniger Strasse 22, 81675 Munich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Deptartment of Hepatobiliary Diseases Leuven University Hospitals</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar, Technische Universität München</name>
      <address>
        <city>Munich</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P. Stradin Clinical University Hospital Gastroenterology Centere Latvijas Universitates Medicinas</name>
      <address>
        <city>Riga</city>
        <zip>1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First city hospital of emergency care Northern State Medical University</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
    <country>Latvia</country>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 17, 2011</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Technical University of Munich</investigator_affiliation>
    <investigator_full_name>Monther Bajbouj</investigator_full_name>
    <investigator_title>PD Dr. med. Hana Algül</investigator_title>
  </responsible_party>
  <keyword>ERCP</keyword>
  <keyword>endoscopy</keyword>
  <keyword>pancreatitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</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/NCT01673763
org study id: 240179
nct id: NCT01673763
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The presented study is designed to analyze the efficacy of pancreatic stent insertion in
      patients undergoing ERCP with accidental cannulation of the pancreatic duct.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Incidence of post-ERCP pancreatitis
time frame: up to 1 week
arm group label: Stent
arm group type: Active Comparator
description: Stent insertion into the main pancreatic duct
arm group label: No stent
arm group type: No Intervention
description: No stent insertion into the main pancreatic duct
intervention type: Device
intervention name: Stent insertion into the main pancreatic duct
description: Stent insertion into the main pancreatic duct
arm group label: Stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Hana Algül, MD, MPH
role: Principal Investigator
affiliation: II. Medizinische Klinik, Klinikum rechts der Isar, Ismaniger Strasse 22, 81675 Munich
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Germany
country: Latvia
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Technical University of Munich
investigator full name: Monther Bajbouj
investigator title: PD Dr. med. Hana Algül
mesh term: Pancreatitis