<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/NCT02971579</url>
  </required_header>
  <id_info>
    <org_study_id>request</org_study_id>
    <nct_id>NCT02971579</nct_id>
  </id_info>
  <brief_title>A Register on the Quality of ERCP and Training of Endoscopists in Italy</brief_title>
  <acronym>REQUEST</acronym>
  <official_title>A Network on the Quality of ERCP, on the Organization of the Endoscopic Units and on the Training of the Endoscopists in Italy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ASST Rhodense</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ASST Rhodense</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective observational longitudinal study&#xD;
&#xD;
      Aim of the study is to collect information:&#xD;
&#xD;
        -  on the organization models of the Endoscopic Units performing ERCP in Italy&#xD;
&#xD;
        -  on the previous and/or ongoing training of the endoscopists performing ERCP&#xD;
&#xD;
        -  on the clinical characteristics of patients undergoing ERCP in Italy as well as on the&#xD;
           outcome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Quality of ERCP in Italy has been object of various, mainly retrospective studies in Italy,&#xD;
      but it has never systematically and prospectively evaluated in a large prospective series.&#xD;
&#xD;
      Moreover, the study aim at collecting data on the organization models of the Endoscopic Units&#xD;
      performing ERCP in Italy; on the previous and/or ongoing training of the endoscopists&#xD;
      performing ERCP; on the clinical characteristics of patients undergoing ERCP in Italy as well&#xD;
      as on the outcome of the procedure&#xD;
&#xD;
      The study consists of 3 phases:&#xD;
&#xD;
        1. Collection of the information on the Endoscopic Unit and on the endoscopists who&#xD;
           performed ERCP in the center&#xD;
&#xD;
        2. Collection of data regarding consecutive ERCPs performed in adult patients in each&#xD;
           center including demographic, clinical and procedural information&#xD;
&#xD;
        3. Definition of the the outcome of ERCP assessed after 30 days from the procedure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complications rate</measure>
    <time_frame>30 days</time_frame>
    <description>Occurrence of post -ERCP complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of repeated procedure</measure>
    <time_frame>30 days</time_frame>
    <description>The rate of ERCPs that have to be repeated within 1 month</description>
  </secondary_outcome>
  <enrollment type="Actual">1800</enrollment>
  <condition>Biliary Tract Diseases</condition>
  <condition>Pancreatic Diseases</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ERCP</intervention_name>
    <description>Endoscopic procedure used to manage biliary and pancreatic diseases</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive adult patients undergoing ERCP for various indications&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Informed consent not subscribed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pietro Occhipinti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AOU Maggiore della Carità Novara</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AOU Maggiore della Carità</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>January 17, 2021</last_update_submitted>
  <last_update_submitted_qc>January 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>ASST Rhodense</investigator_affiliation>
    <investigator_full_name>gianpiero manes</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>ERCP</keyword>
  <keyword>biliary diseases</keyword>
  <keyword>Pancreatic diseases</keyword>
  <keyword>outcome</keyword>
  <keyword>Quality</keyword>
  <keyword>Training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Diseases</mesh_term>
    <mesh_term>Biliary Tract 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/NCT02971579
org study id: request
nct id: NCT02971579
lead sponsor: 
has dmc: No
This is a prospective observational longitudinal study

      Aim of the study is to collect information:

        -  on the organization models of the Endoscopic Units performing ERCP in Italy

        -  on the previous and/or ongoing training of the endoscopists performing ERCP

        -  on the clinical characteristics of patients undergoing ERCP in Italy as well as on the
           outcome
Quality of ERCP in Italy has been object of various, mainly retrospective studies in Italy,
      but it has never systematically and prospectively evaluated in a large prospective series.

      Moreover, the study aim at collecting data on the organization models of the Endoscopic Units
      performing ERCP in Italy; on the previous and/or ongoing training of the endoscopists
      performing ERCP; on the clinical characteristics of patients undergoing ERCP in Italy as well
      as on the outcome of the procedure

      The study consists of 3 phases:

        1. Collection of the information on the Endoscopic Unit and on the endoscopists who
           performed ERCP in the center

        2. Collection of data regarding consecutive ERCPs performed in adult patients in each
           center including demographic, clinical and procedural information

        3. Definition of the the outcome of ERCP assessed after 30 days from the procedure
observational model: Case-Only
time perspective: Prospective
measure: Complications rate
time frame: 30 days
description: Occurrence of post -ERCP complications
measure: Rate of repeated procedure
time frame: 30 days
description: The rate of ERCPs that have to be repeated within 1 month
intervention type: Procedure
intervention name: ERCP
description: Endoscopic procedure used to manage biliary and pancreatic diseases
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Pietro Occhipinti, MD
role: Principal Investigator
affiliation: AOU Maggiore della Carità Novara
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: ASST Rhodense
investigator full name: gianpiero manes
investigator title: MD
mesh term: Pancreatic Diseases
mesh term: Biliary Tract Diseases
sharing ipd: No