<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/NCT01673269</url>
  </required_header>
  <id_info>
    <org_study_id>E12053-A</org_study_id>
    <nct_id>NCT01673269</nct_id>
  </id_info>
  <brief_title>Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD</brief_title>
  <official_title>Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Tech University Health Sciences Center, El Paso</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American College of Gastroenterology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Texas Tech University Health Sciences Center, El Paso</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      When a doctor performs Endoscopic retrograde cholangiopancreatography &quot;ERCP&quot; (Endoscopy to&#xD;
      examine the bile duct) a flexible tube is inserted into the mouth and into the stomach. The&#xD;
      tube passes beyond the stomach and into an opening in the liver called the bile duct. Another&#xD;
      small flexible endoscope is inserted inside the ERCP scope to directly visualize the bile&#xD;
      duct to ensure that there are no cancers or stones in the bile duct and occasionally to take&#xD;
      a sample from the bile duct. The purpose of our study is to examine wither performing this&#xD;
      procedure can transmit bacteria from the bile duct to the main blood stream.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective study to measure the frequency of bacteremia in patients undergoing&#xD;
      ERCP with direct cholangioscopic examination of the Common Bile Duct &quot;CBD&quot;. A blood culture&#xD;
      will be drawn from patients prior to the procedure, 5 minutes after the procedure and 30&#xD;
      minutes after the procedure. The patient will be followed up for 7 days after procedure for&#xD;
      fever and sepsis. The estimated sample size is 60 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD</measure>
    <time_frame>5 minutes and 30 minutes</time_frame>
    <description>To measure the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD by obtaining blood culture 5 minutes and 30 minutes after the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To measure the frequency of fever or sepsis after ERCP with direct cholangioscopic examination of the CBD</measure>
    <time_frame>within 24 hours and one week of the procedures.</time_frame>
    <description>This outcome will be obtained by calling the patient 24 hour and 1 week after the procedure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Choledocholithiasis</condition>
  <condition>Cholangiocarcinoma</condition>
  <condition>Benign Stricture of Common Bile Duct</condition>
  <arm_group>
    <arm_group_label>ERCP with direct examination of the CBD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood culture ( aerobic and anaerobic)</intervention_name>
    <description>Blood culture 5 minutes and 30 minutes after the procedure</description>
    <arm_group_label>ERCP with direct examination of the CBD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic&#xD;
             examination of the common bile duct to ensure the clearance of the common bile duct&#xD;
             from stones.&#xD;
&#xD;
             2- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic&#xD;
             examination of the common bile duct for stone removal.&#xD;
&#xD;
             3- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic&#xD;
             examination of the common bile duct for tissue acquisition from the common bile duct&#xD;
             mass.&#xD;
&#xD;
             4- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic&#xD;
             examination of the common bile duct for tissue acquisition from common bile duct&#xD;
             strictures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1- Patients younger than 18 yrs old or older than 80 yrs. 2- Pregnant patients. 3-&#xD;
             Patient with ascending cholangitis, pneumonia or urinary tract infection 4- Patients&#xD;
             who received antibiotics in the last 2 weeks prior to the procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed O Othman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Tech University at El Paso</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Tech University Health Sciences Center at El Paso</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>May 15, 2017</last_update_submitted>
  <last_update_submitted_qc>May 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas Tech University Health Sciences Center, El Paso</investigator_affiliation>
    <investigator_full_name>Mohamed O Othman</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>ERCP</keyword>
  <keyword>Direct cholangioscopic examination of the common bile duct</keyword>
  <keyword>Choledocholithiasis</keyword>
  <keyword>Cholangiocarcinoma</keyword>
  <keyword>Benign stricture of common bile duct</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacteremia</mesh_term>
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <mesh_term>Choledocholithiasis</mesh_term>
    <mesh_term>Constriction, Pathologic</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/NCT01673269
org study id: E12053-A
nct id: NCT01673269
lead sponsor: 
collaborator: 
has dmc: Yes
When a doctor performs Endoscopic retrograde cholangiopancreatography "ERCP" (Endoscopy to
      examine the bile duct) a flexible tube is inserted into the mouth and into the stomach. The
      tube passes beyond the stomach and into an opening in the liver called the bile duct. Another
      small flexible endoscope is inserted inside the ERCP scope to directly visualize the bile
      duct to ensure that there are no cancers or stones in the bile duct and occasionally to take
      a sample from the bile duct. The purpose of our study is to examine wither performing this
      procedure can transmit bacteria from the bile duct to the main blood stream.
This is a prospective study to measure the frequency of bacteremia in patients undergoing
      ERCP with direct cholangioscopic examination of the Common Bile Duct "CBD". A blood culture
      will be drawn from patients prior to the procedure, 5 minutes after the procedure and 30
      minutes after the procedure. The patient will be followed up for 7 days after procedure for
      fever and sepsis. The estimated sample size is 60 patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD
time frame: 5 minutes and 30 minutes
description: To measure the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD by obtaining blood culture 5 minutes and 30 minutes after the procedure
measure: To measure the frequency of fever or sepsis after ERCP with direct cholangioscopic examination of the CBD
time frame: within 24 hours and one week of the procedures.
description: This outcome will be obtained by calling the patient 24 hour and 1 week after the procedure
arm group label: ERCP with direct examination of the CBD
arm group type: Experimental
intervention type: Other
intervention name: Blood culture ( aerobic and anaerobic)
description: Blood culture 5 minutes and 30 minutes after the procedure
arm group label: ERCP with direct examination of the CBD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mohamed O Othman, MD
role: Principal Investigator
affiliation: Texas Tech University at El Paso
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Texas Tech University Health Sciences Center, El Paso
investigator full name: Mohamed O Othman
investigator title: Assistant Professor
mesh term: Bacteremia
mesh term: Cholangiocarcinoma
mesh term: Choledocholithiasis
mesh term: Constriction, Pathologic
sharing ipd: No