<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/NCT02232451</url>
  </required_header>
  <id_info>
    <org_study_id>loop20216</org_study_id>
    <nct_id>NCT02232451</nct_id>
  </id_info>
  <brief_title>Comparison of Loop-tip Cook Medical® Wire Versus Traditional Endoscopic Technique</brief_title>
  <acronym>loop</acronym>
  <official_title>Comparison of Loop-tip Cook Medical® Wire vs Traditional Endoscopic Technique Cannulation in the Prevention of Post-ercp Pancreatitis and Biliary Tree Access in High-risk Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera San Paolo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera San Paolo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip&#xD;
      for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be&#xD;
      associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the&#xD;
      conventional biliary tree access with contrast injection even if results are conflicting. The&#xD;
      aim of our study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the&#xD;
      prevention of PEP and biliary tree access, in PEP high-risk patients.&#xD;
&#xD;
      Type of study: Multicentric, prospective and randomized trial&#xD;
&#xD;
      Patients: PEP high-risk patients underwent ERCP for benign biliary pathology&#xD;
&#xD;
      Number of patients: 320 patients (160 for each group)&#xD;
&#xD;
      Aim:&#xD;
&#xD;
      Primary end point: The evaluation of the incidence of PEP . Secondary end point: The&#xD;
      evaluation of CBD percentage cannulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2010</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">June 2012</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The evaluation of the incidence of PEP</measure>
    <time_frame>loop20216</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The evaluation of CBD percentage cannulation.</measure>
    <time_frame>loop20216</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Complications of Surgical and Medical Care: General Terms</condition>
  <arm_group>
    <arm_group_label>ERCP with loop tip wire</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ERCP with loop tip wire is an endoscopic procedure to treat biliary disease. Wire guide cannulation with loop-tip is a new procedure to improve rate of biliary cannulation and reduce complication, as post-procedure pancreatitis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERCP for cannulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ERCP for cannulation of CBD with traditional technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ERCP with loop tip wire</intervention_name>
    <description>Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation</description>
    <arm_group_label>ERCP with loop tip wire</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ERCP for cannulation</intervention_name>
    <description>Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation</description>
    <arm_group_label>ERCP for cannulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  high risk patients for post-ERCP pancreatitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 yrs&#xD;
&#xD;
          -  allergy to the contrast medium&#xD;
&#xD;
          -  previous surgery&#xD;
&#xD;
          -  neoplastic bilio-pancreatic disease&#xD;
&#xD;
          -  previous EBS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Enzo Masci, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital San Paolo</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 1, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>September 23, 2014</last_update_submitted>
  <last_update_submitted_qc>September 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera San Paolo</investigator_affiliation>
    <investigator_full_name>Enzo Masci</investigator_full_name>
    <investigator_title>Chief of Gastrointestinal Endoscopy</investigator_title>
  </responsible_party>
  <keyword>loop</keyword>
  <keyword>ERCP</keyword>
  <keyword>cannulation</keyword>
  <keyword>biliary</keyword>
  <keyword>wire</keyword>
  <!-- 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/NCT02232451
org study id: loop20216
nct id: NCT02232451
lead sponsor: 
has dmc: No
The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip
      for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk
      patients.
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be
      associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the
      conventional biliary tree access with contrast injection even if results are conflicting. The
      aim of our study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the
      prevention of PEP and biliary tree access, in PEP high-risk patients.

      Type of study: Multicentric, prospective and randomized trial

      Patients: PEP high-risk patients underwent ERCP for benign biliary pathology

      Number of patients: 320 patients (160 for each group)

      Aim:

      Primary end point: The evaluation of the incidence of PEP . Secondary end point: The
      evaluation of CBD percentage cannulation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The evaluation of the incidence of PEP
time frame: loop20216
measure: The evaluation of CBD percentage cannulation.
time frame: loop20216
arm group label: ERCP with loop tip wire
arm group type: Experimental
description: ERCP with loop tip wire is an endoscopic procedure to treat biliary disease. Wire guide cannulation with loop-tip is a new procedure to improve rate of biliary cannulation and reduce complication, as post-procedure pancreatitis.
arm group label: ERCP for cannulation
arm group type: Active Comparator
description: ERCP for cannulation of CBD with traditional technique
intervention type: Device
intervention name: ERCP with loop tip wire
description: Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation
arm group label: ERCP with loop tip wire
intervention type: Device
intervention name: ERCP for cannulation
description: Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation
arm group label: ERCP for cannulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Enzo Masci, MD
role: Study Director
affiliation: Hospital San Paolo
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera San Paolo
investigator full name: Enzo Masci
investigator title: Chief of Gastrointestinal Endoscopy