<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/NCT04503200</url>
  </required_header>
  <id_info>
    <org_study_id>DGWRCT</org_study_id>
    <nct_id>NCT04503200</nct_id>
  </id_info>
  <brief_title>Double Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.</brief_title>
  <official_title>Double Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Difficult cannulation of the common bile duct is encountered in about 10%of ERCP procedures.&#xD;
      This frequently happens in the form of repeated unintentional cannulation of the pancreatic&#xD;
      duct. Two valid options are available to facilitate cannulation at this point: Double&#xD;
      guidewire technique or performing a transpancreatic precut. This is a randomized trial&#xD;
      comparing the efficacy and Safety of double guidwire technique versus transpancreatic precut&#xD;
      after three unintentional passages of the guidewire into the pancreatic duct.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 15, 2020</start_date>
  <completion_date type="Anticipated">August 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2022</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cannulation success</measure>
    <time_frame>Within 10 minutes</time_frame>
    <description>Proportion of patients with successful cannulation of the common bile duct</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of post-ERCP pancreatitis</measure>
    <time_frame>up to 24 hours after the procedure</time_frame>
    <description>Proportion of patients suffering post-ERCP pancreatitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to successful cannulation</measure>
    <time_frame>Within 10 minutes</time_frame>
    <description>Time to achieve cannulation after the 3rd passage of the guidewire into the pancreatic duct</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Endoscopic Retrograde Cholangiopancreatography</condition>
  <condition>Common Bile Duct Diseases</condition>
  <condition>Transpancreatic Precut</condition>
  <condition>Precut</condition>
  <condition>Double Guidewire</condition>
  <arm_group>
    <arm_group_label>Double guidewire</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Transpancreatic precut</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Double guidewire</intervention_name>
    <description>After the 3rd passage of the guidewire into the pancreatic duct, the catheter will be removed leaving the guidewire in place. The catheter will be re-inserted and a second guidewire will be used and directed above the pancreatic wire in the 11-12 o'clock direction to attempt cannulation of the common bile duct.</description>
    <arm_group_label>Double guidewire</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transpancreatic precut</intervention_name>
    <description>After the 3rd passage of the guidewire unintentionally into the pancreatic duct, the guidewire will be left in the pancreatic duct, a sphincterotome will be used to cut in the direction of 11-12 o'clock attempting to deroof the pancreatic duct and gain access into the common bile duct. The wire will then be retracted and reinserted in the direction of the cut to attempt cannulation of the common bile duct.</description>
    <arm_group_label>Transpancreatic precut</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unintentional cannulation of the pancreatic duct 3 times&#xD;
&#xD;
          -  Consenting to join the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous ERCP with or without previous sphincterotomy&#xD;
&#xD;
          -  Known coagulopathy&#xD;
&#xD;
               -  - Pregnancy&#xD;
&#xD;
               -  - Known acute pancreatitis at the time of procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hany M Shehab</last_name>
    <role>Study Chair</role>
    <affiliation>Kasr-Elaini Faculty of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hany Shehab</last_name>
    <phone>01111111071</phone>
    <email>h.shehab@kasralainy.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Hany M Shehab, MD</last_name>
      <phone>01111111071</phone>
      <email>H.shehab@kasralainy.edu.eg</email>
    </contact>
    <investigator>
      <last_name>Hany M Shehab, FRCP</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hany Shehab</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bile Duct Diseases</mesh_term>
    <mesh_term>Common Bile Duct Diseases</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/NCT04503200
org study id: DGWRCT
nct id: NCT04503200
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Difficult cannulation of the common bile duct is encountered in about 10%of ERCP procedures.
      This frequently happens in the form of repeated unintentional cannulation of the pancreatic
      duct. Two valid options are available to facilitate cannulation at this point: Double
      guidewire technique or performing a transpancreatic precut. This is a randomized trial
      comparing the efficacy and Safety of double guidwire technique versus transpancreatic precut
      after three unintentional passages of the guidewire into the pancreatic duct.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Cannulation success
time frame: Within 10 minutes
description: Proportion of patients with successful cannulation of the common bile duct
measure: Rate of post-ERCP pancreatitis
time frame: up to 24 hours after the procedure
description: Proportion of patients suffering post-ERCP pancreatitis
measure: Time to successful cannulation
time frame: Within 10 minutes
description: Time to achieve cannulation after the 3rd passage of the guidewire into the pancreatic duct
arm group label: Double guidewire
arm group type: Active Comparator
arm group label: Transpancreatic precut
arm group type: Active Comparator
intervention type: Procedure
intervention name: Double guidewire
description: After the 3rd passage of the guidewire into the pancreatic duct, the catheter will be removed leaving the guidewire in place. The catheter will be re-inserted and a second guidewire will be used and directed above the pancreatic wire in the 11-12 o'clock direction to attempt cannulation of the common bile duct.
arm group label: Double guidewire
intervention type: Procedure
intervention name: Transpancreatic precut
description: After the 3rd passage of the guidewire unintentionally into the pancreatic duct, the guidewire will be left in the pancreatic duct, a sphincterotome will be used to cut in the direction of 11-12 o'clock attempting to deroof the pancreatic duct and gain access into the common bile duct. The wire will then be retracted and reinserted in the direction of the cut to attempt cannulation of the common bile duct.
arm group label: Transpancreatic precut
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hany M Shehab
role: Study Chair
affiliation: Kasr-Elaini Faculty of Medicine
last name: Hany Shehab
phone: 01111111071
email: h.shehab@kasralainy.edu.eg
facility: 
contact: 
investigator: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hany Shehab
investigator title: Professor
mesh term: Bile Duct Diseases
mesh term: Common Bile Duct Diseases