<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/NCT04408482</url>
  </required_header>
  <id_info>
    <org_study_id>3509/2019</org_study_id>
    <nct_id>NCT04408482</nct_id>
  </id_info>
  <brief_title>Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?</brief_title>
  <official_title>Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helsinki University Central Hospital</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_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to compare the risk of PEP after pancreatic sphincterotomy&#xD;
      performed for difficult cannulation in a group of patients with and in a group of patients&#xD;
      without placement of a prophylactic pancreatic stent. The definition of difficult cannulation&#xD;
      is defined according to the literature.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2024</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-ERCP pancreatitis rate</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">268</enrollment>
  <condition>Endoscopic Retrograde Cholangiopancreatography</condition>
  <arm_group>
    <arm_group_label>Pancreatic sphincterotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pancreatic sphincterotomy performed in difficult cannulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pancreatic sphincterotomy + pancreatic stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pancreatic sphincterotomy performed in difficult cannulation + pancreatic stent placement</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biliary cannulation</intervention_name>
    <description>Cannulation of biliary duct by sphincterotome</description>
    <arm_group_label>Pancreatic sphincterotomy</arm_group_label>
    <arm_group_label>Pancreatic sphincterotomy + pancreatic stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients with naïve papilla presenting to ERCP with indication of common&#xD;
             bile duct (CBD) cannulation will be considered to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria are age below 18 years, acute pancreatitis and no consent to the&#xD;
             study.&#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_contact>
    <last_name>Andrea Tenca, MD, PhD</last_name>
    <phone>+358408484955</phone>
    <email>ante14@hotmail.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Helsinki Univeristy Hospital</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Tenca, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>March 24, 2022</last_update_submitted>
  <last_update_submitted_qc>March 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Andrea Tenca</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04408482
org study id: 3509/2019
nct id: NCT04408482
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of the study is to compare the risk of PEP after pancreatic sphincterotomy
      performed for difficult cannulation in a group of patients with and in a group of patients
      without placement of a prophylactic pancreatic stent. The definition of difficult cannulation
      is defined according to the literature.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Post-ERCP pancreatitis rate
time frame: 30 days
arm group label: Pancreatic sphincterotomy
arm group type: Active Comparator
description: Pancreatic sphincterotomy performed in difficult cannulation
arm group label: Pancreatic sphincterotomy + pancreatic stent
arm group type: Active Comparator
description: Pancreatic sphincterotomy performed in difficult cannulation + pancreatic stent placement
intervention type: Device
intervention name: Biliary cannulation
description: Cannulation of biliary duct by sphincterotome
arm group label: Pancreatic sphincterotomy
arm group label: Pancreatic sphincterotomy + pancreatic stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Andrea Tenca, MD, PhD
phone: +358408484955
email: ante14@hotmail.it
facility: 
status: Recruiting
contact: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Andrea Tenca
investigator title: Principal investigator
mesh term: Pancreatitis
sharing ipd: Undecided